US Market News
4日前
FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each with Trodelvy® (sacituzumab govitecan-hziy) as First-Line Treatment of PD-L1+ (CPS ≥10) Advanced Triple-Negative Breast Cancer (TNBC)June 25, 2026 6:45 AM
Business Wire First approval of PD-1 inhibitors in combination with a Trop-2-directed antibody-drug conjugate (ADC) in advanced TNBC, marking a potentially practice-changing treatment option Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Trodelvy® (sacituzumab govitecan-hziy), Gilead’s Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-authorized test. These approvals represent the first PD-1 inhibitors plus Trop-2-directed ADC regimen in advanced TNBC. These approvals are based on data from the Phase 3 KEYNOTE-D19/ASCENT-04 trial demonstrating that KEYTRUDA plus Trodelvy reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.51-0.84]; p=0.0009) versus KEYTRUDA plus chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin) for the first-line treatment of adult patients with PD-L1+ (CPS ≥10) unresectable locally advanced or metastatic TNBC. KEYTRUDA plus Trodelvy resulted in a median progression-free survival (PFS) of 11.2 months [95% CI, 9.3-16.7] versus 7.8 months [95% CI, 7.3-9.3] with KEYTRUDA plus chemotherapy. The objective response rate (ORR) was higher with KEYTRUDA plus Trodelvy (61% [95% CI, 55-68]) than with KEYTRUDA plus chemotherapy (55% [95% CI, 48-62]), and complete responses occurred in 12% and 8% of patients, respectively. The effectiveness of KEYTRUDA QLEX for its approved indications has been established based upon evidence from the adequate and well-controlled studies conducted with KEYTRUDA and additional data from MK-3475A-D77 comparing the pharmacokinetic, efficacy and safety profiles of KEYTRUDA QLEX and KEYTRUDA. “For people living with metastatic triple-negative breast cancer, the first treatment choice can be pivotal, as many patients may not have the opportunity to receive subsequent therapies,” said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and a principal investigator of Merck’s KEYNOTE-D19 and Gilead’s ASCENT-04 study. “These approvals are heartening news for patients and the clinical community, and I believe offer practice-changing first-line treatment options.” KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. KEYTRUDA and KEYTRUDA QLEX are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions in any or multiple organs, which can occur during or after treatment, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, other transplant (including corneal graft) rejection; severe and life-threatening infusion or injection-related reactions; fatal and other serious complications in patients who receive allogeneic hematopoietic stem cell transplantation before or after beginning treatment; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when KEYTRUDA or KEYTRUDA QLEX is added to a thalidomide analogue plus dexamethasone, which is not recommended outside of controlled trials. Immune-mediated adverse reactions listed here may not include all such possible severe or fatal reactions. For more information, see “Selected Important Safety Information” below. “Patients with PD-L1+ unresectable locally advanced or metastatic TNBC have limited treatment options in the first-line setting, as this aggressive disease often advances quickly,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We now have new first-line treatment options that combine, for the first time, a PD-1 inhibitor with a Trop-2-directed ADC, and significantly reduce disease progression or death compared to KEYTRUDA plus chemotherapy. Today’s approvals of KEYTRUDA and KEYTRUDA QLEX each in combination with Trodelvy represent a meaningful milestone for those living with advanced TNBC.” Pembrolizumab (KEYTRUDA®) in combination with sacituzumab govitecan-hziy (Trodelvy®) is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer as a category 1 preferred first-line treatment option for certain patients with recurrent unresectable (local or regional) or stage IV (M1) triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10).* “For appropriate patients with metastatic TNBC, a new first-line treatment option offers optimism to a community with historically few choices,” said Ricki Fairley, co-founder and CEO of TOUCH, The Black Breast Cancer Alliance. “TNBC disproportionately affects younger women – many in the prime of their lives – and often leads to poorer outcomes. Because so many patients may never receive subsequent lines of therapy, the ability to start with options like Trodelvy with or without KEYTRUDA or KEYTRUDA QLEX is critical. We have sought additional alternatives to chemotherapy-containing regimens in the first-line metastatic setting since TNBC was classified as a disease more than 20 years ago. As such, these approvals represent meaningful progress for the families impacted by this disease.” The median duration of exposure to KEYTRUDA was 8.5 months (range 1 day to 26.8 months). Fatal adverse reactions occurred in 3.2% of patients receiving KEYTRUDA in combination with sacituzumab govitecan-hziy, including death due to unknown cause (0.9%), and completed suicide, neutropenic sepsis, sepsis, pneumonia and pulmonary embolism (0.5% each). Serious adverse reactions occurred in 38% of patients receiving KEYTRUDA in combination with sacituzumab govitecan-hziy. Serious adverse reactions in ≥2% of patients were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), fatigue and pneumonia (2.3% each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 9% of patients. The adverse reactions which resulted in permanent discontinuation of KEYTRUDA most commonly (≥1%) were pneumonitis and rash (1.4% each). Dosage interruptions of KEYTRUDA due to adverse reactions occurred in 67% of patients. Adverse reactions which required dosage interruption in ≥2% of patients included neutropenia (36%), diarrhea (7%), upper respiratory tract infection (4.5%), anemia (4.1%), fatigue (4.1%), increased alanine aminotransferase (ALT) (3.2%), cough (2.7%), leukopenia (2.7%), nausea (2.7%), pyrexia (2.7%), rash (2.7%), vomiting (2.7%) and COVID-19 (2.3%). The most common (≥25%) adverse reactions, including laboratory abnormalities, occurring in patients treated with KEYTRUDA in combination with sacituzumab govitecan-hziy were decreased neutrophil count and decreased hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and increased glucose (50% each), increased ALT (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache, and increased eosinophils (26% each) and decreased albumin (25%). *According to the NCCN Guidelines (Version 4.2026), category 1 is based upon high-level evidence (≥1 randomized phase 3 trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate. Preferred intervention refers to interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. About KEYNOTE-D19/ASCENT-04 KEYNOTE-D19/ASCENT-04 (ClinicalTrials.gov, NCT05382286) is a Phase 3 multicenter, open-label, randomized, active-controlled trial evaluating KEYTRUDA in combination with sacituzumab govitecan-hziy in patients with unresectable locally advanced or metastatic TNBC, who had not been previously treated with systemic therapy for advanced disease and whose tumors expressed PD-L1 (CPS ≥10) according to the PD-L1 IHC 22C3 pharmDx assay. The primary efficacy endpoint was progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary efficacy endpoints included overall survival (OS) and objective response rate (ORR) as assessed by BICR using RECIST v1.1. Safety also was evaluated. The study enrolled 443 patients who were randomized 1:1 to receive either KEYTRUDA (200 mg intravenously [IV] on Day 1 of each 21-day cycle) plus sacituzumab govitecan-hziy (10 mg/kg IV on Days 1 and 8 of each 21-day cycle) (n=221) or KEYTRUDA (200 mg IV on Day 1 of each 21-day cycle) plus chemotherapy (n=222). The chemotherapy regimen included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel. Assessment of tumor status was performed every 8 weeks for the first 18 months, and every 12 weeks thereafter. Treatment beyond BICR-verified disease progression per RECIST 1.1 was permitted if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. Crossover to sacituzumab govitecan-hziy monotherapy was offered following disease progression and study treatment discontinuation. About triple-negative breast cancer (TNBC) Triple-negative breast cancer is an aggressive type of breast cancer; it has the highest risk of recurrence within the first five years after treatment and is associated with worse outcomes compared to other forms of breast cancer. Approximately 10-15% of patients with breast cancer are diagnosed with TNBC. While some breast cancers may test positive for estrogen receptors (ER), progesterone receptors (PR) or overexpression of human epidermal growth factor receptor 2 (HER2), TNBC tests negative for ER and PR, and does not overexpress HER2. Triple-negative breast cancer tends to be more common in people who are younger than age 40, who are Black or who have certain gene mutations. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. About KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use, 165 mg + 2,000 units/mL KEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL). KEYTRUDA QLEX must be administered by a healthcare provider. Selected Indications in the U.S. for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Triple-Negative Breast Cancer KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then each continued as a single agent as adjuvant treatment after surgery. KEYTRUDA and KEYTRUDA QLEX, each in combination with sacituzumab govitecan-hziy, are indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with chemotherapy, for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. See additional selected indications for KEYTRUDA and KEYTRUDA QLEX in the U.S. after the Selected Safety Information. Selected Safety Information for KEYTRUDA and KEYTRUDA QLEX Contraindications KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA and KEYTRUDA QLEX are monoclonal antibodies that belong to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA or KEYTRUDA QLEX in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA and KEYTRUDA QLEX depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA and KEYTRUDA QLEX require interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Immune-mediated pneumonitis occurred in 5% (13/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including fatal (0.4%), Grade 3 (2%), and Grade 2 (1.2%) adverse reactions. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (
US Market News
5日前
Next-Generation DNA Repair Inhibitors Could Capture Billions in Emerging MarketJune 24, 2026 9:00 AM
InvestorsHub NewsWireNext-Generation DNA Repair Inhibitors Could Capture Billions in Emerging MarketBioMedWire Editorial Coverage: Oncology research is moving through one of its most active stretches in years. DNA Damage Response ("DDR") inhibitors, a category of drugs that work by blocking cancer cells' capacity to fix their own damaged DNA, are growing well beyond the poly ADP ribose polymerase ("PARP") inhibitor that first defined the category. DDR-inhibiting therapies generated an estimated $7 billion-plus in worldwide sales in 2025, and the wider oncology, diagnostics and precision medicine markets are expected to approach about $750 billion by 2030. A fresh wave of inhibitor classes is now taking shape as the next major opportunity. Standing at the leading edge of this shift is Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (Profile), a Canadian clinical-stage oncology company developing ONC010(TM), a nanoparticle-encapsulated PNKP inhibitor designed to target a DNA repair enzyme that participates in several distinct repair pathways. As the industry works toward the next generation of synthetic lethality assets, Onco-Innovations occupies a distinctive niche as it builds out its position within the biopharmaceutical and biotechnology space, alongside other established companies such as Merck & Co. Inc. (NYSE: MRK), Pfizer Inc. (NYSE: PFE), GSK plc (NYSE: GSK) and Gilead Sciences Inc. (NASDAQ: GILD), all of which are focused on developing therapies for serious illnesses, including cancer.PARP inhibitors reshaped oncology when they first reached patients some 10 years ago, but they represent just one entry point into a much larger and more intricate biological network.Onco-Technologies owns exclusive worldwide rights to a foundational set of PNKP inhibitor technologies.The company's preclinical program has generated concrete, measurable outcomes that support the biological case for PNKP inhibition in solid tumors.Onco-Innovations holds global rights across three separate layers of protection, with each layer reinforcing the others.Click here to view the custom infographic of the Onco-Innovations editorial.DNA Repair Science Expands Past the PARP EraPARP inhibitors reshaped oncology when they first reached patients some 10 years ago. They put into practice a concept known as synthetic lethality, in which cancers carrying particular DNA repair defects could be selectively destroyed by disabling a secondary repair pathway. The effect was striking in BRCA-mutated cancers, and the drug class has since grown into a market worth billions of dollars. Yet PARP inhibitors represent just one entry point into a much larger and more intricate biological network.The DNA Damage Response system involves dozens of proteins and pathways that cancer cells depend on to withstand chemotherapy, radiation and other forms of cellular stress. Researchers have spent years systematically charting this network in search of new drug targets. A field once confined to academic circles is now attracting serious investment and clinical interest. Artios Pharma, for instance, closed a $115 million Series D financing round late last year to advance mid-stage studies of experimental cancer drugs targeting DNA repair mechanisms beyond PARP, one of the strongest signals yet that this segment has matured into an investable category.The clinical pipeline backs up that narrative. Last month, Artios dosed its first patient in a randomized phase 2 trial of ART6043, a DNA polymerase theta inhibitor, in patients with gBRCA-mutated, HER2-negative breast cancer, advancing a non-PARP DDR target into mid-stage, biomarker-guided development. Also last month, MD Anderson released phase 1 proof-of-concept results for RO7589831, a Werner helicase inhibitor, in cancers exhibiting high microsatellite instability. These are not minor announcements; they demonstrate that novel DDR mechanisms can produce real clinical responses in actual patients.Interest from potential partners in DDR assets has remained resilient even amid broader market turbulence. Last year, Repare Therapeutics out-licensed lunresertib to Debiopharm in a deal worth $10 million upfront, plus up to $257 million tied to milestones. Debiopharm went on to secure U.S. Food and Drug Administration ("FDA") Fast Track designation for a lunresertib combination in April 2026, converting a licensing arrangement into a formal regulatory achievement. The takeaway for investors appears straightforward: Biomarker-defined DDR assets backed by a credible scientific mechanism can still attract partners and earn regulatory recognition, even when funding conditions remain cautious.Polynucleotide Kinase Phosphatase, or PNKP, is a DNA repair enzyme that functions across numerous repair pathways, addressing both single-strand and double-strand break repair. This broader scope gives PNKP inhibitors a potentially wider therapeutic reach than PARP inhibitors, which act primarily on single-strand break repair. Inhibiting PNKP has already shown preclinical activity in colorectal, lung, breast, prostate, ovarian and blood cancers. With worldwide PARP inhibitor revenue forecast to total roughly $12 billion by 2030, PNKP inhibitors are surfacing as a significant drug class positioned to capture share within the expanding DNA Damage Response segment. Onco-Innovations has established itself as the recognized leader for this novel DDR target.Holding First-Mover Ground in Wide-Open CategoryMost competitive space in oncology drug development becomes crowded quickly. PARP inhibitors, PD-1 checkpoint drugs and CDK4/6 inhibitors each drew dozens of rivals once their commercial promise became evident. PNKP inhibitors stand apart from that pattern. The target has been described in academic literature for years, yet the drug-development community has been slow to act on it. That hesitancy created an opening, and Onco-Innovations has moved directly into it.The company owns exclusive worldwide rights to a foundational set of PNKP inhibitor technologies. This encompasses the core inhibitor compounds, the nanoparticle delivery science needed to carry those compounds effectively to tumors, and the synthetic lethality applications that define how the therapy is meant to function. Holding rights across molecular design, delivery mechanism and therapeutic application simultaneously is uncommon at this stage of oncology development.The competitive value of this position becomes clearer with added information. Once a new DDR target draws widespread industry attention, patent landscapes become congested, valuations climb and the window for first movers closes. Onco-Innovations entered the PNKP space while that window was still open. The company's patents cover the PNKP inhibitor technology as well as the ONC010 program, extending protection across the small molecule inhibitors themselves, the delivery system and the clinical applications, which together form a wide and durable competitive barrier.The broader DDR market supplies the commercial backdrop. Per the company, DDR-inhibiting products surpassed $7 billion in global sales last year. The global oncology market overall is forecast to approach $500 billion by 2032, representing growth of 131% across a 10-year span. Within that landscape, PNKP inhibitors occupy a category with no approved competitor and no entrenched incumbent. Rather than fighting for share in an already mature market, the company is effectively building the market itself.Laboratory Evidence Lays Groundwork for Clinical TrialsAmong the central risk factors in early-stage oncology investing is the distance separating laboratory findings from clinical reality. Onco-Innovations has worked methodically to close that gap. The company's preclinical program has generated concrete, measurable outcomes that support the biological case for PNKP inhibition in solid tumors.The standout finding from animal studies relates to survival outcomes in colorectal cancer. Published preclinical data show that the company's novel nanoparticle formulation, ONC010, extended median survival to 60 days in mice with PTEN-deficient colorectal cancer, compared with 23 days in untreated animals, more than double the survival duration. The same body of research showed substantial tumor growth reduction relative to placebo, paired with a favorable toxicity profile.The lack of observed toxicity in animal models carries particular weight. DDR inhibitors have generally run into off-target effects that constrain their clinical usefulness. Onco-Innovations' nanoparticle delivery system was built specifically to deal with this challenge. By pairing the active pharmaceutical ingredient A83B4C63 with a polymer-based micellar carrier, the platform extends circulation time and encourages preferential buildup within tumor tissue while reducing exposure to healthy cells.The company has continued advancing its Chemistry, Manufacturing and Controls program alongside its preclinical research. Onco-Innovations is carrying out manufacturing scale-up and formulation development with Dalton Pharma Services, while running IND-enabling studies, including pharmacokinetic and biodistribution work, with Nucro-Technics. The company recently reported successful API process development and intermediate-scale production for its PNKP inhibitor technology, the kind of key manufacturing announcements that reduce risk on the path toward a first-in-human trial.The company has also set up a subsidiary in Australia to back anticipated phase 1 development through the Therapeutic Goods Administration regulatory pathway. Activation of a first-in-human phase 1 trial is planned later this year. The anticipated clinical approach is underpinned by validated preclinical data, a clear regulatory roadmap and the possibility of pursuing Fast Track designation, considering the substantial unmet need across the target indications.Intellectual Property Designed to Protect ExclusivityIntellectual property forms the foundation of value in early-stage drug development. Without critical IP, clinical achievements fail to result in commercial exclusivity. Onco-Innovations has constructed its IP portfolio with that principle firmly in place. The company owns global rights across three separate layers of protection, with each layer reinforcing the others.The first layer covers the core PNKP inhibitor molecules, the foundational drug candidates from which ONC010 and future programs are derived. The second layer covers the nanoparticle delivery science, specifically the polymer-based micellar carrier system that enables effective tumor-targeted delivery of the inhibitors. This delivery technology is not a peripheral feature; it is central to the program's ability to achieve efficacy without unacceptable toxicity. The third layer protects synthetic lethality applications, which outlines how the therapy is matched to specific tumor biology to maximize selective destruction of cancer cells.Collectively, these patents provide comprehensive protection for the PNKP technology and the ONC010 program. The portfolio is designed to included not just the current lead compound but the main platform itself, supporting the company's specified objective of increasing its PNKP inhibitor technology across additional cancer types.For example, the company has wrapped up a collaborative project with Kuano, applying a quantum-based computational chemistry platform to generate insights aimed at optimizing PNKP inhibitor technology, further reinforcing the molecular foundation underlying the program.Causal AI Speeds Up Precision-Focused Trial DesignDrug development remains costly and slow. The typical oncology drug requires more than a decade and over $1 billion to reach the market, and most candidates that enter clinical trials ultimately fail. Artificial intelligence is being applied with growing frequency to improve those odds, not by substituting for biology but by making it easier to identify the right patients, design more effective trials and interpret results more rapidly.With this in mind, last year Onco-Innovations acquired Inka Health Corp. Inka Health's SynoGraph(TM) platform prototype is a proprietary causal AI engine built specifically for oncology applications. Unlike standard machine learning, which identifies statistical correlations, causal AI is designed to reason about cause-and-effect relationships, a difference that carries significant weight in clinical research, where the gap between association and true causation can be the reason a drug appears effective or ineffective.The SynoGraph offering is designed to support patient stratification, clinical trial design, translational decision-making and evidence generation. The exclusive prototype will combine real-world data, clinical evidence and molecular insights to help predict trial outcomes, treatment efficacy and safety, as well as adverse events. For a company preparing to launch a first-in-human trial, the ability to pinpoint the right patient population before the trial even begins represents a meaningful reduction in clinical risk rather than a mere convenience.Inka Health is also working with both AstraZeneca and GlaxoSmithKline in collaborations centered on predictive modeling, real-world evidence and AI-enabled cancer study. These companies are far from minor partners. And last month, Inka Health started a research partnership within PROmAI, additionally broadening the range of applications for the SynoGraph platform.Folding SynoGraph into the ONC010 development program means Onco-Innovations can use AI-driven patient stratification across its planned clinical studies. This provides the potential to shorten enrollment timelines, enhance the signal within early efficacy data and increase the overall potential for success. Precision-focused trial design is increasingly becoming a significant differentiator within oncology, and Onco-Innovations is working to build that capability internally.Biotech Innovation Continues Advancing Patient CareRecent developments across the biotechnology industry highlight continued progress in the development of innovative therapies and preventive treatments for a wide range of serious diseases. Companies are achieving important regulatory milestones, reporting encouraging clinical trial results and advancing next-generation treatment approaches designed to improve patient outcomes.Merck & Co. Inc. (NYSE: MRK) announced that the FDA has approved an expanded indication for CAPVAXIVE(R) (Pneumococcal 21-valent Conjugate Vaccine). The indication will include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. With this approval, CAPVAXIVE is the only PCV specifically indicated and studied in the United States for use in this patient population.Pfizer Inc. (NYSE: PFE) announced that the FDA has approved an expanded indication for HYMPAVZI(R) (marstacimab-hncq). The expanded indication includes the treatment of patients, diagnosed with hemophilia A or B, who are 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. HYMPAVZI is now indicated in the United States for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors.GSK plc (NYSE: GSK) is reporting interim phase 2 data from the global phase 2/3 ROSETTA Lung-02 clinical trial. The trial evaluated the investigational PD-L1xVEGF-A bispecific immunomodulator pumitamig, also known as BNT327 or BMS-986545, plus chemotherapy in patients with previously untreated advanced non-small cell lung cancer ("NSCLC"). The data showed encouraging anti-tumor activity, with high response rates observed in both nonsquamous and squamous NSCLC and at each PD-L1 expression level. The data was presented at the 2026 American Society of Clinical Oncology Annual Meeting.Gilead Sciences Inc. (NASDAQ: GILD) announced that the primary efficacy endpoint at Week 48 was met in both the phase 3 ISLEND-1 and ISLEND-2 trials with the investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir. The ISLEND trials are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in people with HIV who are virologically suppressed and switched from BIKTARVY(R) (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2). The safety profile of ISL/LEN was generally comparable to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified.As scientific innovation continues to accelerate, the biotechnology sector remains at the forefront of transforming healthcare through novel medicines, advanced biologics and precision treatment strategies. These achievements reflect a growing pipeline of therapies that have the potential to reshape treatment standards and deliver meaningful benefits to patients across diverse disease areas.For further information about Onco-Innovations, visit the Onco-Innovations profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today's market, BMW brings its clients unparalleled recognition and brand awareness.BMW is where breaking news, insightful content and actionable information converge.To receive SMS alerts from BioMedWire, "Biotech" to 888-902-4192 (U.S. Mobile Phones Only)For more information, please visit https://www.BioMedWire.comDISCLAIMER: BioMedWire (BMW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by BMW are solely those of BMW. Readers of this Article and content agree that they cannot and will not seek to hold liable BMW for any investment decisions by their readers or subscribers. BMW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.The Article and content related to the profiled company represent the personal and subjective views of the Author and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. None of the Author, BMW, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer's filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer's securities, including, but not limited to, the complete loss of your investment.BMW HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and BMW undertakes no obligation to update such statements.Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/DisclaimerBioMedWire
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5日前
The Quest to Repair What Multiple Sclerosis Takes AwayJune 24, 2026 9:00 AM
InvestorsHub NewsWireThe Quest to Repair What Multiple Sclerosis Takes AwayBioMedWire Editorial Coverage: Multiple sclerosis ("MS") gradually strips people of command over their own bodies, advancing steadily with no available cure. More than 2.9 million people across the globe are currently living with the disease. But even with generations of scientific study and research, every approved treatment still falls short of one essential objective: bringing the disease to a complete stop. Existing therapies can slow its advance, but none can halt it outright. That shortfall translates into a future of mounting disability for millions of MS sufferers. Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (Profile) is determined working to change that outcome. The company is developing Lucid-MS, a patented, first-in-class drug candidate that approaches the disease from an entirely different angle by directly targeting the myelin sheath that MS destroys; the potential treatment is now preparing to move into phase 2 clinical trials. Quantum BioPharma stands among a group of companies pursuing therapies for neurological, autoimmune and immune-mediated conditions, a group that also includes Novartis AG (NYSE: NVS), Merck & Co. Inc. (NYSE: MRK), TG Therapeutics Inc. (NASDAQ: TGTX) and Bristol Myers Squibb Company (NYSE: BMY).Multiple sclerosis is especially destructive because of its tendency to worsen progressively.Instead of working through the immune system, Quantum BioPharma's Lucid-MS acts directly on the myelin sheath.The scientific case behind Lucid-MS rests on years of disciplined research.Quantum BioPharma has finished dosing in both 180-day, repeated-dose oral toxicity and toxicokinetic studies for Lucid-21-302.Click here to view the custom infographic of the Quantum BioPharma editorial.A Disease That Erodes Movement, IndependenceMultiple sclerosis is a long-term inflammatory condition affecting the central nervous system. In MS, the immune system mistakenly attacks the brain and spinal cord, damaging myelin, the protective coating around nerve fibers that allows electrical impulses to travel efficiently. As myelin breaks down, these signals slow, falter or fail altogether, resulting in a mix of symptoms that can include tingling, vision disturbances, mobility difficulties, cognitive decline and, over time, a progressive erosion of physical control.MS does not spare any age group. The worldwide average age at diagnosis is 32, with an estimated 1.5% of all those with MS diagnosed before turning 18. Women receive an MS diagnosis at twice the rate of men. Within the United States alone, close to one million people are currently living with the disease in the United States, a number that more than doubled over earlier figures once researchers applied more rigorous, contemporary counting methods. Unfortunately, the trend continues upward, with prevalence climbing in every region of the world since 2013.In addition, MS is especially destructive because of its tendency to worsen progressively. Many patients initially experience a relapsing-remitting pattern, in which symptoms flare and then partially subside. Over time, however, a substantial share of patients shift into secondary progressive MS, a phase marked by steadily accumulating disability. According to the National MS Society, many people with MS end up juggling several medications at once, with each med addressing a separate symptom or relapse episode, yet none capable of confronting the underlying nerve damage that continues to erode their quality of life.The disease also imposes a substantial financial toll. The worldwide market for MS therapeutics was valued at roughly $27.4 billion in 2024 and is projected to climb to $38.62 billion by 2030, a trajectory driven not by curative treatments but by the sheer volume of patients requiring care across their lifetimes. That market dynamic highlights just how large the unmet need truly is. Patients require more than ongoing management; they need a therapy capable of interrupting the disease process itself.That is exactly the objective Quantum BioPharma has set out to achieve. The company is advancing Lucid-MS, a patented, first-in-class drug candidate unlike any therapy currently on the market, one engineered to act on the myelin sheath directly with the aim of preventing and protecting its breakdown.Acting Directly on the Myelin SheathThe majority of approved MS treatments function by modulating the immune system. They subdue or redirect the immune response responsible for attacking myelin, an approach that can lower relapse frequency and slow the buildup of disability. These therapies have delivered genuine clinical progress. Yet none of them directly address the myelin tissue itself or work to rebuild what has already been lost. For patients in the progressive stages of MS, immune modulation alone frequently proves inadequate.Lucid-MS charts an entirely separate course. Known technically as Lucid-21-302, the candidate is a patented New Chemical Entity, classified as a first-in-class, nonimmunomodulatory, neuroprotective compound. Instead of working through the immune system, Lucid-MS acts directly on the myelin sheath. In preclinical models, it has demonstrated the ability to protect myelin from degradation, a key pathological process underlying multiple sclerosis. No currently approved treatment offers a comparable mechanism of action.A defining feature of Lucid-MS is that it does not impact immune function. That quality separates it from most existing MS therapies and may translate into a meaningful safety benefit. It also frames Lucid-MS not as a substitute for immune-modulating drugs but as a potential complement to them, or should future trial results support its early promise, as a foundational therapy in its own right. The drug is also being advanced in an oral form, which would offer patients greater convenience than the injectable or infusion-based treatments many currently rely on.Quantum BioPharma controls exclusive global rights to Lucid-MS through its wholly owned subsidiary, Lucid Psycheceuticals Inc. The program is guided by a top-tier scientific team that includes advisor Dr. Lakshmi P. Kotra, recipient of the Julia Levy Award, a senior scientist at the University Health Network and a professor of medicinal chemistry at the University of Toronto. The scientific team also includes Dr. Andrzej Chruscinski, vice president of Scientific and Clinical Affairs, whose career spans Stanford-trained internal medicine alongside cardiology and neurological research. This group is working toward something no approved drug has yet accomplished: an MS therapy that directly safeguards myelin.From Laboratory Findings to Human StudiesThe scientific case behind Lucid-MS rests on years of disciplined research. The compound has undergone study for upward of a decade, with findings published in some of medicine's most respected journals, including the "Journal of Medicinal Chemistry" and the "Proceedings of the National Academy of Sciences." These peer-reviewed papers track the compound's indicated capacity to prevent demyelination in preclinical settings.The animal-model results are notable. Across experiments carried out in multiple laboratories over the course of several years, Lucid-MS sped up functional recovery in mouse models of MS, preserved myelin integrity and reduced regional degradation. Documented results report that, following treatment, mice regain the capability to walk. This outcome did not stem from isolated experiments but from an extensive body of studies. The results proved compelling enough to justify advancing the compound into human trials.Quantum BioPharma presented its phase 1 clinical trial application for Lucid-MS to evaluate first-in-human safety and tolerability in 2023. The trial encompassed both Single Ascending Dose ("SAD") and Multiple Ascending Dose ("MAD") phases, which were administered among healthy volunteers. Results from the clinical study report identified no safety or tolerability concerns associated with daily dosing. Dosing in phase 1 among healthy human volunteers was successfully completed, with Lucid-MS characterized as exhibiting a favorable safety profile and good tolerability.Should upcoming phase 2 trials in MS patients confirm what the preclinical work suggested — that Lucid-MS can stop and prevent myelin degradation — it would represent an unprecedented milestone. No therapy currently approved for MS has shown the ability to help patients regain physical function previously lost to myelin damage. While human trials remain necessary to determine whether the preclinical results carry over to patients, a decade's worth of accumulated data provides a scientifically credible basis for that optimism.Submitting the IND, Preparing for Phase 2Late last year, the company finished dosing in both 180-day, repeated-dose oral toxicity and toxicokinetic studies for Lucid-21-302. These studies represent essential elements of the Investigational New Drug ("IND") application that the U.S. Food and Drug Administration ("FDA") requires before authorizing a phase 2 trial. Completing these extended safety studies marked a meaningful advance toward formal regulatory submission.The company additionally entered into agreements with a leading contract development and manufacturing organization to develop and produce an oral formulation of Lucid-MS, a critical step in preparing the drug for clinical use. Following that, in April this year, Quantum BioPharma officially filed its IND application with the FDA for Lucid-MS, aiming for a phase 2 trial designed to assess the therapy's efficacy, safety and tolerability among people living with MS.To carry out a phase 2 trial, Quantum BioPharma announced a binding letter of intent with Allucent, a global contract research organization with extensive experience running central nervous system trials. Quantum BioPharma also named a principal investigator for the upcoming trial, marking further progress in the clinical development program. These steps are indicative of an organization that has advanced methodically from encouraging preclinical results to taking the steps towards producing the human clinical data the MS community is waiting for.A Pioneering Partnership Sheds Light on the Path ForwardQuantum BioPharma is concurrently working with a tool that could prove vital to assessing Lucid-MS's effectiveness: an advanced imaging technique capable of directly visualizing myelin within the living human brain. Quantum BioPharma recently launched a joint clinical study with researchers at Massachusetts General Hospital ("MGH") to validate a novel positron emission tomography imaging method for tracking myelin integrity and demyelination in MS.The study centers on a PET tracer known as [¹8F]3F4AP, developed by Dr. Pedro Brugarolas, who is an investigator in the Department of Radiology at MGH and an assistant professor at Harvard Medical School. Dr. Eric Klawiter, director of the Multiple Sclerosis and Neuromyelitis Optica Unit at MGH and an associate professor of neurology at Harvard Medical School, is co-investigator on the project.In June of last year, the first patient with MS was scanned successfully, which marked the formal start of active patient enrollment. The MGH research team also published encouraging results in the "European Journal of Nuclear Medicine and Molecular Imaging," in a study funded by the National Institutes of Health. The tracer exhibited strong properties for brain imaging and, notably, was able to distinguish differences among lesions that conventional MRI could not detect. Last month, the study reached the midpoint of patient enrollment, with preliminary imaging results showing encouraging signal strength in acute MS lesions.The importance of this imaging work to Lucid-MS's development is difficult to overstate. One of the central challenges in developing any remyelinating therapy is confirming whether it is genuinely working, and conventional MRI cannot provide a direct, quantitative measure of myelin. Assuming it is validated, the [¹8F]3F4AP tracer could supply precisely that: a real-time biological window into how effectively a drug is protecting or restoring the myelin sheath.Chruscinski has noted that this tool has the potential to fundamentally reshape how demyelination is assessed, offering a direct view into axonal health and enabling clearer demonstration of how therapies such as Lucid-MS perform. This collaboration among the University Health Network, Massachusetts General Hospital and researchers affiliated with Harvard Medical School brings together world-class scientific expertise around a common purpose.Quantum BioPharma is laser focused on that objective. With the global MS therapeutics market projected to surpass $38 billion by 2030, the commercial stakes involved are substantial. Yet for the nearly three million people living with MS worldwide, what matters most is whether a therapy can finally achieve what none has accomplished before: Halting the disease, repairing the damage it causes and restoring the bodily control that MS has taken away. Should Lucid-MS fulfill its preclinical promise in human trials, it would represent more than a new drug; it would mark a genuine turning point.Advancing Treatment Options Across SectorsRecent developments across the biopharmaceutical industry highlight continued momentum in the development of therapies for autoimmune, immune-mediated and chronic inflammatory diseases. Companies are reporting encouraging clinical results, expanding development programs and achieving important regulatory milestones as they work to address conditions that can significantly impact quality of life and often remain difficult to treat.Novartis AG (NYSE: NVS) presented data from the RemIND trial at the European Academy of Allergy and Clinical Immunology ("EAACI") Congress. The data showed that Rhapsido(R) (remibrutinib) met its primary endpoints across the three most common chronic inducible urticaria (CIndU) subtypes, becoming the first-ever treatment to demonstrate efficacy in a global Phase III CIndU clinical trial. In the RemIND trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. These results demonstrate that Rhapsido may provide sustained relief for patients whose disease remains inadequately controlled after treatment with second-generation H1-antihistamines.Merck & Co. Inc. NYSE: MRK) announced positive topline results from the phase 3 ATLAS-UC induction-only study (study 2). The study evaluated tulisokibart ("MK-7240"), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A ("TL1A"), in patients with moderately to severely active UC. The study successfully met its primary endpoint of clinical remission according to the Modified Mayo Score at week 12, as well as key secondary endpoints. In addition, consistent with previously reported phase 2 studies, no safety concerns were identified.TG Therapeutics Inc. (NASDAQ: TGTX) reported positive topline phase 1 data for subcutaneous BRIUMVI in patients with myasthenia gravis. The company also announced theinitiation of a phase 2 clinical trial evaluating BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG. The company noted that the encouraging results support continued development of BRIUMVI in MG and also mark an important milestone in expanding the potential utility of BRIUMVI beyond multiple sclerosis.Bristol Myers Squibb Company (NYSE: BMY) announced that the European Commission has approved Opdivo(R) (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine for the treatment of adult and adolescent patients 12 years of age and older with previously untreated stage 3 or 4 classical Hodgkin lymphoma. This approval marks a significant milestone, establishing the Opdivo plus AVD combination as the first immunotherapy-based regimen available in the European Union for newly diagnosed advanced cHL.As scientific understanding of immune system dysfunction continues to evolve, researchers are uncovering new therapeutic targets and refining treatment strategies across a broad range of diseases. These efforts reflect a growing focus on delivering therapies that offer greater efficacy, convenience and durability while helping address substantial unmet medical needs.For further information about Quantum BioPharma Ltd., visit the Quantum BioPharma profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today's market, BMW brings its clients unparalleled recognition and brand awareness.BMW is where breaking news, insightful content and actionable information converge.To receive SMS alerts from BioMedWire, "Biotech" to 888-902-4192 (U.S. Mobile Phones Only)For more information, please visit https://www.BioMedWire.comDISCLAIMER: BioMedWire (BMW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by BMW are solely those of BMW. Readers of this Article and content agree that they cannot and will not seek to hold liable BMW for any investment decisions by their readers or subscribers. BMW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.The Article and content related to the profiled company represent the personal and subjective views of the Author and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. None of the Author, BMW, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer's filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer's securities, including, but not limited to, the complete loss of your investment.BMW HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and BMW undertakes no obligation to update such statements.Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/DisclaimerBioMedWire
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2週前
U.S. FDA Approves an Additional Indication for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) in Children and Adolescents Aged 2 through 17 at Increased Risk for Pneumococcal DiseaseJune 18, 2026 6:45 AM
Business Wire CAPVAXIVE is the only Pneumococcal Conjugate Vaccine (PCV) specifically indicated and studied in the U.S. for use in this population CAPVAXIVE, when added to existing primary pediatric pneumococcal vaccination series, helps deliver additional protection by including serotypes not contained in approved primary pediatric PCV series Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. With this approval, CAPVAXIVE is the only PCV specifically indicated and studied in the U.S. for use in this patient population. CAPVAXIVE is indicated for: Active immunization for the prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older and individuals 2 through 17 years of age who are at increased risk for pneumococcal disease; Active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. CAPVAXIVE should not be administered to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid; see additional Select Safety Information below. The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. “Children and adolescents with certain chronic conditions are at an increased risk for pneumococcal disease, including pneumonia, meningitis, and bloodstream infections,” said Dr. Rotem Lapidot, Chief of Pediatric Infectious Diseases at Rambam Health Care Campus, investigator, STRIDE-13 trial. “This approval recognizes the potential of CAPVAXIVE to deliver additional protection by including serotypes not contained in approved primary pediatric PCV series, and represents a new approach to helping protect children and adolescents at increased risk for pneumococcal disease.” The approval is based on data from the Phase 3 STRIDE-13 trial, which evaluated CAPVAXIVE compared to PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in children and adolescents aged 2 through 17 years who completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk of pneumococcal disease. See “STRIDE-13 Clinical Data Supporting Approval” below for additional details. “While CAPVAXIVE was specifically designed for adults, it may also offer additional disease protection for this specific population of children and adolescents, when given after the primary pediatric pneumococcal vaccination series,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories. “The approval of CAPVAXIVE for children and adolescents at increased risk for pneumococcal disease demonstrates our commitment to addressing this disease in people of all ages, not only addressing an unmet need, but also reinforcing Merck’s longstanding commitment to public health and infectious diseases.” The expanded indication for CAPVAXIVE complements existing primary pediatric pneumococcal vaccination series for children and adolescents at increased risk for pneumococcal disease. According to a 2025 study of 2015-2019 CDC ABC surveillance data, including three groups, one of which consisted of children 10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%). The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%). The most commonly reported (>10%) solicited adverse reactions in individuals 2 through 17 years of age who are at increased risk for pneumococcal disease were: injection-site pain (67.7%), injection-site erythema (24.3%), fatigue (20.1%), injection-site swelling (18.8%), headache (17.1%), malaise (13.3%), and irritability (11.6%). Vaccination with CAPVAXIVE may not protect all vaccine recipients. STRIDE-13 Clinical Data Supporting Approval STRIDE-13 (NCT06177912) is a randomized, double-blind, active comparator-controlled Phase 3 study that evaluated individuals 2 through 17 years of age with one or more prespecified medical conditions (diabetes mellitus, chronic heart disease, chronic kidney disease, chronic liver disease, chronic lung disease) known to increase the risk of pneumococcal disease and who have previously completed a primary pneumococcal vaccination regimen at least 8 weeks prior to enrollment (n=874). Participants were randomized 3:2 to receive a single dose of CAPVAXIVE (n=527) or PPSV23 (n=347). Results from the study include: CAPVAXIVE was noninferior to PPSV23 for the 12 shared serotypes and induced statistically significantly greater OPA GMTs compared to PPSV23 for the 9 serotypes unique to CAPVAXIVE; CAPVAXIVE also elicited immune responses to serotype 15B (cross-reactive to serotype 15C). In a post hoc analysis utilizing the same prespecified noninferiority criterion that was used for the shared serotypes, CAPVAXIVE was noninferior to PPSV23 for serotype 15B; The safety profile of CAPVAXIVE was generally comparable to PPSV23. Solicited adverse reactions following administration of CAPVAXIVE lasted a median of 2 days with most reactions lasting ≤3 days; The proportion of individuals reporting 1 or more serious adverse events (SAE) within 6 months postvaccination was 5.5% (n=29) in individuals vaccinated with CAPVAXIVE and 7.2% (n=25) in individuals vaccinated with PPSV23. There were no notable patterns or imbalances between vaccine groups for SAEs. One individual (0.2%) who received CAPVAXIVE had an SAE considered related to vaccination. This SAE was syncope (Grade 2, required hospitalization) and occurred approximately 3 minutes postvaccination. About Pneumococcal Disease Pneumococcal disease is an infection caused by bacteria called Streptococcus pneumoniae. There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Pneumococcal disease can be invasive or non-invasive. Non-invasive pneumococcal illnesses include pneumonia (when pneumococcal disease is confined to the lungs), whereas invasive pneumococcal illnesses include pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumococcal pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord). About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Please see the Prescribing Information for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) at https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_pi.pdf and the Patient Information/Medication Guide for CAPVAXIVE at https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_ppi.pdf . View source version on businesswire.com: https://www.businesswire.com/news/home/20260618416609/en/ Media Contacts: Olivia Finucane
004 7881 262476
olivia.finucane @katsi
alayna.shamy@merck.com Investor Contacts: Peter Dannenbaum
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damini.chokshi@merck.com Original: U.S. FDA Approves an Additional Indication for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) in Children and Adolescents Aged 2 through 17 at Increased Risk for Pneumococcal Disease
US Market News
2週前
Study Reveals Dog Owners and Veterinarians See Challenges in Treating Allergic Skin Disease, Highlighting a Need for a Targeted Rapid Onset Treatment for Dogs of All AgesJune 17, 2026 6:45 AM
Business Wire Efficacy and safety are top preferences when selecting antipruritic treatments, but dog owners and veterinarians want options that are easier to administer, more affordable and improve compliance Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced results from a new global survey of dog owners and veterinarians revealing challenges and pain points associated with diagnosing the underlying cause of allergic skin disease in dogs and its treatment. According to Pet Owner and Vet Perspectives on Canine Pruritus: A Global Survey, about one-third of canine patients seen by U.S. veterinarians have itchy skin or allergic skin disease (27% of global canine patients) and about two in five dogs with skin conditions are newly diagnosed (U.S. and global). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260617911309/en/ Both dog owners and veterinarians feel fatigued and burdened by canine allergic skin disease, with 34% of U.S. dog owners reporting a notable negative impact on their own quality of life (31% globally). Additionally, 43% of dog owners who have dogs with itchy skin in the U.S. (39% globally) indicated a significant negative impact on the dog's quality of life. In fact, 86% of U.S. dog owners (90% globally) who have taken their dog with scratchy/itchy skin to the vet have discussed their dog’s itch with their vet with 61% of those dog owners specifically making the appointments with their veterinarian to discuss their pet’s itchy skin (60% globally). The survey also revealed that both dog owners and veterinarians have difficulty finding an effective treatment, with 28% of U.S. dog owners and 36% of U.S. veterinarians having switched therapies used to treat allergic skin disease in the last year (compared to globally 29% and 41%, respectively). To access vet and pet owner resources, click here. “Allergic skin disease is one of the most common clinical signs among dogs of all ages. Knowing that many dog owners and veterinarians are managing dogs with allergic skin disease, we wanted to understand the challenges they are facing when it comes to diagnosis, treatment, and compliance,” said Linda Horspool, BVMS, PhD, DipECVPT, FRCVS, Director Scientific Marketing Affairs, Global Marketing Companion Animals, Merck Animal Health. “We found that while veterinarians and owners both experience frustrations when communicating with one another about diagnosing the underlying cause of allergic skin disease and treatment plans, both parties have the same goal of finding a solution that is effective, safe and starts working fast.” The insights from 1,710 dog owners and 1,413 veterinarians across 11 countries (8 countries for dog owners) revealed notable differences in their preferences, priorities and motivations for treating allergic skin disease in dogs. The findings underscore that dog owners and veterinarians both prioritize improving the quality of life of patients, but there are gaps in communication about the underlying cause of allergic skin disease, what to expect, the treatment selected, and how compliance impacts efficacy. Key Findings When selecting antipruritic therapies for their dogs, the top three features U.S. owners look for are efficacy, safety and specifically targeting itch.
When asked to select the features they felt are most important in a treatment for their itchy dog, owners in the U.S. and globally ranked effectiveness for itch as most important, safety profile as second most important and targeted for itch as third most important in the highest tier of importance. Globally and in the U.S. veterinarians ranked effectiveness and rapid onset as the most important features.
Despite listing safety and efficacy as a feature of most importance, antihistamines and corticosteroids use remains high
In dogs, antihistamines can cause drowsiness or hyperactivity, long-term or high-dose corticosteroids can lead to serious issues like immune suppression, vomiting, diarrhea, and Cushing's disease. Yet, 41% of U.S. dog owners report having used antihistamines to treat canine allergic skin disease in the last year (27% globally), while 23% report using corticosteroids (19% globally). Fifteen percent report using JAK inhibitors (11% globally), and 8% report using monoclonal antibodies (11% globally), which typically have fewer safety concerns and side effects.i
Veterinarians and dog owners in the U.S. stopped using antipruritic treatment for the same top reasons – lack of efficacy and safety concerns.
For U.S. dog owners, the top reasons they discontinued use of antipruritic treatment were because the product was not as effective as they’d like it to be (32%), the product was too costly/expensive (28%), they had safety concerns (21%), and one dose did not last long enough (21%). For U.S. veterinarians, 44% cited poor efficacy, 38% cited less targeted treatment, and 28% cited poor safety profile. While U.S. dog owners and veterinarians were aligned, global dog owners differed with top reasons being poor efficacy (22%), slow to start (20%), and my dog did not enjoy receiving it (18%). Globally, veterinarians also most frequently cited poor efficacy (46%), less targeted treatment (31%), and poor safety profile (27%).
Both veterinarians and dog owners were motivated to start using a treatment that was easier to administer and improved compliance.
U.S. dog owners who started a new treatment cited top factors for starting the treatment as recommended by veterinary staff (40%), safer for my dog (38%), and easier to administer or apply to my dog (35%). Reasons why U.S. veterinarians started recommending a treatment were: better efficacy (46%), innovative treatment that adds to the toolbox (44%), better client compliance (28%), more targeted treatment (26%) and price (26%). Globally, dog owners cited recommended by my vet (32%), easier to administer or apply to my dog (32%), and safer for my dog (31%). Globally, veterinarians cited better efficacy (48%), innovative treatment that adds to the toolbox (36%), more targeted treatment (32%),faster onset of action (27%) and better client compliance (26%).
Some available treatments come with a cost burden. When asked about unmet needs in current antipruritic treatments, the majority of veterinarians said there was a gap in cost effective, more affordable options.
52% of U.S. veterinarians and 46% of veterinarians globally said the top unmet need for canine antipruritic treatment is more cost-effective options. Additionally, about 1 in 10 veterinarians globally (6% of U.S. veterinarians) said medication for dogs 6 months of age or older was an unmet need. 13% of dogs with allergic skin conditions seen by veterinarians worldwide were 6–11 months old (9% in the US) and therefore too young to receive a JAK inhibitor that is approved for dogs 12 months and older.
Additional global qualitative findings suggest that both dog owners and veterinarians desire better communication and understanding of treatment plans and disease progression/ what to expect.
Interviews with 60 veterinarians and 25 dog owners from across five countries including the U.S. revealed key themes around the allergic skin disease journey. The chronic nature and variability of the condition make it difficult to manage from patient to patient, leading to veterinarian fatigue. Veterinarians also reported that pet owners have a misunderstanding of the chronic nature of allergic skin disease and how treatments work, causing compliance to suffer. Meanwhile, pet owners shared that they try to create a routine, but some are forced to spread out doses to counteract costs. Many owners also reported not receiving enough information or instruction from their veterinarian. Study Methodology This quantitative study collected data through an online survey administered by a professional market research organization, adhering to global market research guidelines and codes of conduct. The study captured data from a representative sample of 1,413 companion animal veterinarians across 11 countries: the US, Canada, Australia, Japan, Brazil, Mexico, UK, France, Germany, Spain, and Poland. Data was also captured among a representative sample of 1,710 dog owners across 8 countries: the US, Canada, Australia, Mexico, UK, France, Germany, and Spain. Qualifying dog owner participants were 18+ years of age, owned 1–4 dogs and were primary or shared decision makers regarding their dog’s healthcare. They had to own a dog that has exhibited or been treated for signs of atopic/allergic dermatitis in the past 12 months (includes both diagnosed and undiagnosed dogs). To reduce bias, participants affiliated with animal health companies or market research firms were excluded. The study targeted a representative sample of owner demographics, including geography, gender, age and household income. The survey took approximately 24 minutes to complete and was conducted from 20 February to 16 April 2025. Qualified respondents were asked about their dog’s condition, diagnosis, and impact of the disease, followed by a series of questions assessing treatment use, frequency of treatment, and perception of treatments. They were also asked to provide their thoughts on factors driving them to select a treatment, and factors that identify an ideal treatment, also to provide their opinions on a potential new product concept for allergic skin conditions. If a respondent had multiple dogs, they were asked to focus on the dog that has exhibited or been treated for signs of atopic/allergic dermatitis in the past 12 months. Qualifying veterinarian participants were full-time veterinarians who personally see itchy/pruritic dogs including atopic dermatitis cases, had been practicing veterinary medicine for 2–40 years, were primary/co-decision makers regarding products recommended or prescribed at their practices. The study targeted a representative mix of participant demographics, such as gender and age, and practice demographics, such as location, size and ownership type (corporate versus independent). Participants were excluded if they were competitively employed or serving in an advisory capacity to animal health, market research and/or pharmaceutical companies. The survey was fielded from 4 November 2024 to 13 January 2025 and took approximately 38 minutes to complete. Qualified participants answered questions assessing their canine patient load with the disease, their approach to treatment of allergic skin conditions, their perceptions of treatments, and the key factors that drive their selection of treatments. They were also asked to provide their opinions on a potential new product concept for allergic skin conditions. Responses were collected and reviewed in an anonymized format. Open, free-text responses were grouped according to subject. Analysis consisted of descriptive analytics. About Merck Animal Health Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is a global animal health business committed to The Science of Healthier Animals™. For more than 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. For more information, visit www.merck-animal-health.com and connect with us on LinkedIn, Facebook, X (formerly Twitter) and Instagram. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). ### i Sousa CA. Glucocorticoids in veterinary dermatology. In: Bonagura JD, Twedt DC, eds. Kirk's Current Veterinary Therapy. 14th ed. St Louis, MO: Saunders Elsevier; 2009:400-404. View source version on businesswire.com: https://www.businesswire.com/news/home/20260617911309/en/ Merck Investor Contacts:
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ahglobalmedia@merck.com Original: Study Reveals Dog Owners and Veterinarians See Challenges in Treating Allergic Skin Disease, Highlighting a Need for a Targeted Rapid Onset Treatment for Dogs of All Ages
US Market News
2週前
FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With WELIREG® (belzutifan), for Adjuvant Treatment of Certain Patients With Clear Cell Renal Cell Carcinoma (ccRCC)June 12, 2026 4:10 PM
Business Wire Marks the first approved combinations of a PD-1 and HIF-2a inhibitor Approvals based on Phase 3 LITESPARK-022 trial that showed KEYTRUDA in combination with WELIREG reduced the risk of disease recurrence, metastasis or death by 28% compared to KEYTRUDA plus placebo Represents the first and only global Phase 3 study to have demonstrated an improvement in disease-free survival over KEYTRUDA monotherapy in adjuvant ccRCC Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with WELIREG® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor, for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. These approvals represent the first approval for WELIREG in earlier-stage ccRCC and the first approvals for PD-1 and HIF-2a inhibitor combination regimens. The approvals are based on results from the pivotal Phase 3 LITESPARK-022 trial. LITESPARK-022 enrolled 1,841 patients and demonstrated that KEYTRUDA in combination with WELIREG significantly improved disease-free survival (DFS), the trial’s primary endpoint, reducing the risk of disease recurrence, metastasis or death by 28% (HR=0.72 [95% CI 0.59-0.87]; p=0.0003) for patients with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions compared to KEYTRUDA plus placebo. The estimated 24-month DFS rate was 81% (95% CI 0.78-0.83) with KEYTRUDA plus WELIREG compared to 74% (95% CI 0.71-0.77) with KEYTRUDA plus placebo. Median DFS was not reached in either arm. Overall survival (OS) results were not yet mature at this interim analysis. The effectiveness of KEYTRUDA QLEX for its approved indications has been established based upon evidence from the adequate and well-controlled studies conducted with KEYTRUDA and additional data from MK-3475A-D77 comparing the pharmacokinetic, efficacy, and safety profiles of KEYTRUDA QLEX and KEYTRUDA. The WELIREG prescribing information contains a boxed warning that exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception. WELIREG can render some hormonal contraceptives ineffective. WELIREG can cause severe anemia that can require blood transfusion. Monitor for anemia before initiation of, and periodically throughout, treatment with WELIREG. WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen or hospitalization. Monitor oxygen saturation before initiation of, and periodically throughout, treatment with WELIREG. For more information, see “Selected Safety Information” below. KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. KEYTRUDA and KEYTRUDA QLEX are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions in any or multiple organs, which can occur during or after treatment, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, other transplant (including corneal graft) rejection; severe and life-threatening infusion or injection-related reactions; fatal and other serious complications in patients who receive allogeneic hematopoietic stem cell transplantation before or after beginning treatment; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when KEYTRUDA or KEYTRUDA QLEX is added to a thalidomide analogue plus dexamethasone, which is not recommended outside of controlled trials. Immune-mediated adverse reactions listed here may not include all such possible severe or fatal reactions. For more information, see “Selected Safety Information” below. “Patients with earlier-stage renal cell carcinoma at high risk of recurrence after surgery may see their cancer return, frequently as metastatic disease,” said Dr. Toni K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg professor of medicine, Harvard Medical School. “The results of the LITESPARK-022 trial demonstrated the ability of pembrolizumab in combination with belzutifan to reduce the risk of disease recurrence, metastasis, or death by 28%, which represents an important new option for these patients to help keep their clear cell renal cell carcinoma from coming back.” “Reflecting on my own experience as a clinical oncologist, I know the significant impact that improved disease-free survival can have on the lives of patients,” said Dr. M. Catherine Pietanza, vice president, global clinical development, Merck Research Laboratories. “These approvals demonstrate Merck’s commitment to pursuing innovative treatment options that may help these patients experience longer periods without disease.” “The FDA approval of the novel KEYTRUDA and WELIREG combination is exciting news for the kidney cancer community,” said Bryan Lewis, CEO and co-founder, KidneyCan. “This progress reflects an important step in addressing the needs of patients with earlier-stage renal cell carcinoma.” Study design and additional data from LITESPARK-022 LITESPARK-022 is a multicenter, randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05239728) evaluating WELIREG in combination with KEYTRUDA compared to placebo plus KEYTRUDA for the adjuvant treatment of ccRCC post nephrectomy. Eligible patients had intermediate-high or high risk of recurrence of RCC, or M1 no evidence of disease (NED). Patients must have undergone a partial or radical nephrectomy, and if indicated, metastasectomy within two years of nephrectomy, within ≥4 weeks prior to the time of screening. Patients were excluded from the trial if they had received prior systemic therapy for advanced RCC. The trial enrolled 1,841 patients who were randomized (1:1) to receive either: WELIREG (120 mg orally once daily) plus KEYTRUDA (400 mg intravenously [IV] every six weeks) for up to 9 cycles (54 weeks) until disease recurrence or unacceptable toxicity (n=921), or; KEYTRUDA (400 mg IV every six weeks) plus oral placebo for up to 9 cycles (54 weeks) until disease recurrence or unacceptable toxicity (n=920). The major efficacy outcome measure was investigator-assessed DFS and an additional outcome measure was OS. The safety of WELIREG in combination with KEYTRUDA was evaluated in LITESPARK-022. A total of 915 patients received WELIREG in combination with KEYTRUDA and a total of 913 patients received oral placebo in combination with KEYTRUDA. The median duration of exposure to WELIREG was 12.4 months (range 1 day to 20.1 months). The median duration of exposure to KEYTRUDA in the treatment arm was 11.1 months (range: 1 day to 16.1 months). Serious adverse reactions occurred in 30% of patients who received WELIREG in combination with KEYTRUDA. The most frequently reported serious adverse reactions (≥1%) were pneumonia (2%), hypoxia (1.9%), pneumonitis (1.6%), arrhythmia (1.5%), diarrhea (1.1%), and acute kidney injury (1.1%). Fatal adverse reactions occurred in 1.1% of patients who received WELIREG in combination with KEYTRUDA, including sepsis (0.1%). WELIREG was permanently discontinued due to adverse reactions in 27% of patients. Adverse reactions which resulted in permanent discontinuation of WELIREG in ≥1% of patients included anemia (4%), fatigue (2.2%), rash (2%), increased alanine aminotransferase (ALT) (1.7%), hypoxia (1.6%), diarrhea (1.4%), pneumonitis (1.3%), increased aspartate aminotransferase (AST) (1.1%), and hepatic function abnormal (1%). KEYTRUDA was permanently discontinued due to adverse reactions in 23% of patients. Adverse reactions which resulted in permanent discontinuation of KEYTRUDA in ≥1% of patients included increased ALT (4.5%), increased AST (3%), pneumonitis (2.4%), diarrhea (2.4%), and rash (1.5%). Dosage interruptions of WELIREG due to an adverse reaction occurred in 52% of patients. Of the patients who received WELIREG in combination with KEYTRUDA, 30% were ≥65 years old and 5% were ≥75 years old. Dose interruptions of WELIREG occurred in 57% of patients ≥65 years of age and in 49% of younger patients. Adverse reactions which required dosage interruption of WELIREG in ≥2% of patients included anemia (25%), fatigue (3.7%), increased ALT (3.5%), diarrhea (3.4%), increased AST (3.4%), COVID-19 (2.6%), hypoxia (2.5%), pyrexia (2.5%), musculoskeletal pain (2.1%), and rash (2.1%). Dose interruptions of KEYTRUDA due to an adverse reaction occurred in 29% of patients. Adverse reactions which required dosage interruption of KEYTRUDA in ≥2% of patients included anemia (3.2%), diarrhea (3%), increased ALT (3%), and increased AST (2.5%). Dose reductions of WELIREG due to an adverse reaction occurred in 34% of patients. Dose reductions of WELIREG occurred in 39% of patients ≥65 years of age and in 32% of younger patients. Adverse reactions which required dose reduction in ≥3% of patients included anemia (17%), hypoxia (3.5%), increased ALT (3.2%), and fatigue (3.1%). The most common (≥25%) adverse reactions, including laboratory abnormalities, in patients who received WELIREG in combination with KEYTRUDA were decreased hemoglobin (95%), increased ALT (57%), fatigue (49%), increased AST (46%), decreased lymphocytes (38%), and increased alkaline phosphatase (29%). About renal cell carcinoma Renal cell carcinoma (RCC) is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer diagnosed and approximately 156,000 deaths from the disease worldwide. In the U.S., it is estimated there will be more than 80,000 new cases of kidney cancer diagnosed and more than 15,000 deaths from the disease in 2026. Renal cell carcinoma is about twice as common in men as in women. Cases of RCC might be discovered incidentally during imaging tests for other reasons. Clear cell renal cell carcinoma, which accounts for 70% of RCC diagnoses, is the most common subtype. About Merck’s early-stage cancer clinical program Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is evaluating our portfolio of medicines and pipeline candidates in earlier disease states, with more than 30 ongoing registrational studies across multiple types of cancer. About Merck’s research in genitourinary cancers Merck is advancing research aimed at helping transform the treatment landscape and broaden options for people with genitourinary (GU) cancers, including bladder, kidney and prostate cancers. Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equaling over 1 in 8 of all cancer incidences. Through a robust clinical development program with more than 50 ongoing clinical trials evaluating more than 22,000 patients around the world, Merck is investigating the potential of several portfolio medicines and pipeline assets, leveraging multiple novel combination strategies, across various stages of disease, to help address unmet needs in GU cancers. About WELIREG® (belzutifan) 40 mg tablets, for oral use WELIREG, Merck’s first-in-class hypoxia-inducible factor 2 alpha (HIF-2a) inhibitor, is an orally administered small-molecule that in conditions of hypoxia or impairment of VHL protein function, blocks HIF-2alpha and HIF-1beta interaction, which may reduce the transcription and expression of HIF-2a target genes associated with cellular proliferation, angiogenesis and tumor growth. By inhibiting HIF-2a signaling, WELIREG may disrupt key pathways certain tumors may use to adapt to low-oxygen conditions, including those that help promote abnormal blood vessel formation and support tumor survival. WELIREG has received prior regulatory approvals in certain patients with von Hippel-Lindau (VHL) disease-associated tumors, advanced renal cell carcinoma with a clear cell component (ccRCC) and pheochromocytoma or paraganglioma (PPGL). As part of a broader clinical program, Merck continues to research WELIREG for people with RCC and selected solid tumors across different treatment settings, to further understand where WELIREG may provide clinical benefit. Indications for WELIREG (belzutifan) in the U.S. von Hippel-Lindau (VHL) disease WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Renal Cell Carcinoma with a Clear Cell Component (ccRCC) WELIREG, in combination with KEYTRUDA or KEYTRUDA QLEX, is indicated for the adjuvant treatment of adult patients with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. WELIREG is indicated for the treatment of adult patients with advanced ccRCC following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). Pheochromocytoma or Paraganglioma (PPGL) WELIREG is indicated for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). Selected Safety Information for WELIREG Warning: Embryo-Fetal Toxicity Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception as WELIREG can render some hormonal contraceptives ineffective. Anemia WELIREG can cause severe anemia that can require blood transfusion. Monitor for anemia before initiation of, and periodically throughout, treatment with WELIREG. Transfuse patients as clinically indicated. Withhold, reduce dose, or permanently discontinue WELIREG based on severity. In LITESPARK-004 (N=61), decreased hemoglobin occurred in 93% of patients with VHL disease and 7% had Grade 3 events. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months). The safety of erythropoiesis-stimulating agents (ESAs) for treatment of anemia in patients with VHL disease treated with WELIREG has not been established. In LITESPARK-005 (n=372), decreased hemoglobin occurred in 88% of patients with advanced ccRCC and 29% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 16.6 months). Of the patients with anemia, 22% received transfusions only, 20% received ESAs only, and 12% received both transfusion and ESAs. In LITESPARK-022 (n=915), decreased hemoglobin occurred in 95% of patients receiving adjuvant treatment for ccRCC and 11% had Grade 3 or higher events. Median time to onset of anemia was 42 days (range: 1 day to 11.1 months). Of the patients with anemia, 5% received transfusions only, 8% received ESAs only, and 1.3% received both transfusion and ESAs. In LITESPARK-015 (n=72), anemia occurred in 96% of patients with PPGL and 22% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 22.1 months). Of the patients with anemia, 20% received transfusions only, 26% received ESAs only, and 6% received both transfusion and ESAs. Hypoxia WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization. Monitor oxygen saturation before initiation of, and periodically throughout, treatment. For decreased oxygen saturation with exercise (e.g., pulse oximeter 3% of patients were hypoxia, nausea, and fatigue (4.2% each). Dose reductions due to an adverse reaction occurred in 14% of patients. The most frequently reported adverse reaction which required dose reduction was hypoxia (4.2%). The most common (≥25%) adverse reactions, including laboratory abnormalities, that occurred in patients were anemia (96%), fatigue (56%), musculoskeletal pain (56%), decreased lymphocytes (54%), increased alanine aminotransferase (51%), increased aspartate aminotransferase (42%), increased calcium (34%), dyspnea (33%), increased potassium (31%), decreased leukocytes (30%), headache (29%), increased alkaline phosphatase (25%), dizziness (26%) and nausea (25%). Drug Interactions Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended. Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates or lead to therapeutic failures. Avoid coadministration with sensitive CYP3A4 substrates. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information. Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding. Lactation Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose. Females and Males of Reproductive Potential WELIREG can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG. Use of WELIREG may reduce the efficacy of hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose. Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential and the reversibility of this effect is unknown. Pediatric Use Use of WELIREG in pediatric patients aged 12 years and older is supported by evidence from an adequate and well-controlled study of WELIREG in adults with additional pharmacokinetic data demonstrating that belzutifan exposure is predicted to be within range of that observed in adults, and that the course of locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma is sufficiently similar in adults and pediatric patients to allow extrapolation of data in adults to pediatric patients. The safety and effectiveness of WELIREG have not been established in patients with VHL or ccRCC, or in pediatric patients younger than 12 years of age with PPGL. Renal Impairment For patients with severe renal impairment (eGFR 15-29 mL/min estimated by MDRD), monitor for increased adverse reactions and modify the dosage as recommended. Hepatic Impairment For patients with moderate and severe hepatic impairment, monitor for increased adverse reactions and modify the dosage as recommended. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. About KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use, 165 mg + 2,000 units/mL KEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL). Selected Indications in the U.S. for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Renal Cell Carcinoma KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with axitinib, for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA and KEYTRUDA QLEX are each indicated for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with WELIREG, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. See additional selected KEYTRUDA and KEYTRUDA QLEX indications in the U.S. after the Selected Safety Information. Selected Safety Information for KEYTRUDA and KEYTRUDA QLEX Contraindications KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA and KEYTRUDA QLEX are monoclonal antibodies that belong to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA or KEYTRUDA QLEX in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA and KEYTRUDA QLEX depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA and KEYTRUDA QLEX require interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Immune-mediated pneumonitis occurred in 5% (13/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including fatal (0.4%), Grade 3 (2%), and Grade 2 (1.2%) adverse reactions. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (
US Market News
3週前
Merck and Gilead Provide Update on Phase 3 KEYNOTE-D46/EVOKE-03 StudyJune 8, 2026 4:30 PM
Business Wire Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Gilead Sciences, Inc. (Nasdaq: GILD) today announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 study investigating Gilead’s Trodelvy® (sacituzumab govitecan-hziy) in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, compared to KEYTRUDA monotherapy in certain patients with previously untreated metastatic non-small cell lung cancer, whose tumors expressed PD-L1 (tumor proportion score [TPS] ≥50%). The decision is based on the recommendation from the external Data Monitoring Committee (eDMC) following their review of the data from the pre-specified final analysis of progression-free survival (PFS) and interim analysis of overall survival (OS). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608789974/en/ A numerical improvement in PFS was observed, but did not reach statistical significance. The probability of achieving statistically significant OS is unlikely at the planned final analysis. The safety profile of Trodelvy in combination with KEYTRUDA was consistent with the known safety of each agent. No new safety signals were identified with the combination. These data will be presented at a future medical meeting. Regulatory authorities have been informed. Merck will inform study investigators of the recommendation from the DMC and advise patients in the study to speak to their physician regarding treatment. There are no changes to ongoing Trodelvy or Merck studies. The companies are grateful to the patients, families, and healthcare professionals who participated in the KEYNOTE-D46/EVOKE-03 study and contributed to this important work. Trodelvy is a registered trademark of Gilead Sciences, Inc., or its related companies. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Metastatic Non-Small Cell Lung Cancer Lung cancer is one of the most common cancers worldwide, with an estimated 2.5 million new cases reported globally in 2022. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of lung cancers, and nearly half of these NSCLC patients are diagnosed only after the disease has spread, when treatment options are more limited and long-term survival remains low. Despite treatment advances, the 5-year survival rate for metastatic NSCLC is less than 10%. While immunotherapy, with or without chemotherapy, is a standard first treatment option, it does not work for everyone, and new treatment options are needed. About KEYNOTE-D46/EVOKE-03 The KEYNOTE-D46/EVOKE-03 study is a global, open-label, randomized Phase 3 trial, sponsored by Merck, evaluating the efficacy and safety of Trodelvy (sacituzumab govitecan-hziy) in combination with KEYTRUDA (pembrolizumab) compared with KEYTRUDA monotherapy in patients with previously untreated metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 with a tumor proportion score (TPS) ≥50% and do not have sensitizing EGFR, ALK or ROS1 genomic alterations. Approximately 620 patients were enrolled across study sites worldwide. Patients were randomized 1:1 to receive either Trodelvy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) plus KEYTRUDA (200 mg intravenously on Day 1 of a 21-day cycle), or KEYTRUDA monotherapy (200 mg intravenously on Day 1 of a 21-day cycle). KEYTRUDA was administered for up to 35 cycles, and Trodelvy was continued until disease progression, death, unacceptable toxicity or another treatment discontinuation criterion was met. The dual primary endpoints of the study are progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST v1.1, and overall survival (OS). Secondary endpoints include objective response rate (ORR), duration of response (DOR), patient-reported outcomes (PROs) and safety. More information about the study is available at ClinicalTrials.gov: NCT05609968. About Trodelvy Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect. Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Healthcare professionals have well-established experience with Trodelvy, which has shown generally consistent outcomes across both clinical trials and real-world use in more than 75,000 breast cancer patients across 60+ countries. Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in small cell lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity. Indications for Trodelvy TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. U.S. Important safety information FOR TRODELVY BOXED WARNING: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. CONTRAINDICATIONS Severe hypersensitivity reaction to TRODELVY. WARNINGS AND PRECAUTIONS Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI. Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments. Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions. Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting. Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function. Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose. ADVERSE REACTIONS In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%). In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes. In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes. DRUG INTERACTIONS UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY. UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY. Please see full Prescribing Information, including BOXED WARNING. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA® (pembrolizumab) Indications in the U.S. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Important Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (
US Market News
3週前
Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV TreatmentJune 8, 2026 4:35 PM
Business Wire – Novel Investigational Combination Pairs Merck’s Islatravir, a Next-Generation Nucleoside Analog with Distinct Mechanisms of Action, Including Reverse Transcriptase Translocation Inhibition, with Gilead’s Lenacapavir, a First-in-Class Capsid Inhibitor that Disrupts HIV at Multiple Stages of its Lifecycle – – Islatravir/Lenacapavir has the Potential to be the First Approved Long-Acting Oral HIV Treatment Taken Once-Weekly – Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the primary efficacy endpoint at Week 48 was met in both the Phase 3 ISLEND-1 and ISLEND-2 trials with the investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir. The ISLEND trials are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in people with HIV who are virologically suppressed and switched from BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2). The safety profile of ISL/LEN was generally comparable to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified. Gilead and Merck plan to file the Phase 3 data from the ISLEND trials with regulatory authorities globally and submit the detailed findings for presentation at a future scientific congress. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608276598/en/ “Long-acting oral therapies represent a new wave of transformational innovation in HIV drug development, with the potential to reshape the landscape of care,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences. “Innovative oral HIV treatment options that allow for less frequent dosing may make a meaningful difference in the lives of people living with the virus, potentially offering more flexibility and discretion.” The primary efficacy endpoint of ISLEND-1 and ISLEND-2 was the percentage of participants with HIV-1 RNA levels ≥ 50 copies/mL at Week 48, defined by the FDA snapshot algorithm. In the double-blind ISLEND-1 trial, the once-weekly, single-tablet regimen of ISL/LEN was found to be statistically non-inferior to BIKTARVY. In the open-label ISLEND-2 trial, ISL/LEN was found to be statistically non-inferior to standard of care daily oral antiretroviral therapy regimens. The safety profile of ISL/LEN was generally comparable to BIKTARVY in ISLEND-1 and to standard of care antiretroviral regimens in ISLEND-2. “These results underscore the shared focus and commitment that we and our collaborators at Gilead have on continuing research to help people living with HIV. By advancing this investigational novel once-weekly oral regimen of islatravir and lenacapavir, we aim to bring forward a new long-acting oral option that, if approved, would represent the first of its kind with less frequent dosing and further expand options for people living with HIV,” said Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. The combination of islatravir and lenacapavir targets multiple stages of HIV-1 replication, potentially offering people with HIV who are virologically suppressed a novel, long-acting oral single-tablet regimen. The potency and pharmacokinetic profiles of islatravir and lenacapavir enable long-acting dosing as a once-weekly tablet for HIV treatment, if approved. Islatravir and lenacapavir in combination are investigational and not approved for use. There is currently no cure for HIV or AIDS. About ISLEND-1 ISLEND-1 (NCT06630286) is a Gilead-sponsored, multicenter Phase 3 randomized, double-blind, active-controlled trialdesigned to evaluate the safety and efficacy of switching to a once-weekly tablet of islatravir/lenacapavir (ISL/LEN) versus continuing treatment with BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) in people with virologically suppressed HIV (HIV-1 RNA levels < 50 copies/mL) on BIKTARVY for ≥ 6 months prior to screening. Participants were randomized 1:1 to receive initial doses of ISL/LEN on Day 1 and Day 2 followed by once-weekly ISL/LEN from Day 8 to Week 96 plus placebo-to-match BIKTARVY daily, or BIKTARVY daily plus placebo-to-match initial doses of ISL/LEN on Day 1 and Day 2 and placebo-to-match once-weekly ISL/LEN from Day 8 to Week 96. The primary endpoint was the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48, as determined by the US FDA-defined snapshot algorithm. Key secondary endpoints included the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96, as determined by the US FDA-defined snapshot algorithm; the proportion of participants with virologic suppression (HIV viral load < 50 copies/mL per US FDA Snapshot) at Week 48 and Week 96; change from baseline in CD4 cell count at Week 48 and Week 96; and the proportion of participants treated with ISL/LEN who discontinued treatment due to treatment-emergent adverse events. About ISLEND-2 ISLEND-2 (NCT06630299) is a Gilead-sponsored, multicenter Phase 3 randomized, open-label, active-controlled trialevaluating the safety and efficacy of switching to a once-weekly tablet of ISL/LEN versus continuation of standard of care treatment in people with virologically suppressed HIV (HIV-1 RNA levels < 50 copies/mL) on a stable standard of care antiretroviral regimen for ≥ 6 months prior to screening. A standard of care regimen included two or three antiretroviral medicines, including integrase strand transfer inhibitors (INSTI), nucleoside reverse transcriptase inhibitors (NRTIs), boosted protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI). Participants either received an initial dose of ISL/LEN followed by once-weekly ISL/LEN from Day 8 to Week 96, or continued their standard of care treatment with two/three antiretroviral medicines up to Week 96. The primary endpoint is the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 by FDA-defined Snapshot Algorithm. Key secondary endpoints included the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96, as determined by the US FDA-defined snapshot algorithm; the proportion of participants with virologic suppression (HIV viral load < 50 copies/mL per US FDA Snapshot) at Week 48 and Week 96; change from baseline in CD4 cell count at Week 48 and Week 96; and the proportion of participants treated with ISL/LEN who discontinued treatment due to treatment-emergent adverse events. About Lenacapavir The multi-stage mechanism of action of lenacapavir is distinguishable from other approved classes of antiretroviral agents. While most antiretrovirals act on one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known exhibited cross-resistance in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV treatment and prevention research program. Lenacapavir is being developed as a foundation for potential future HIV therapies to offer both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono-agent, that help address the individual needs and preferences of people and communities affected by HIV. For an overview of Gilead’s HIV treatment and prevention clinical development program, please click here. About Islatravir (MK-8591) Islatravir (MK-8591) is Merck’s potent, next-generation nucleoside analog that blocks HIV-1 replication by multiple mechanisms including inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and induction of structural changes in the viral DNA (delayed chain termination). Islatravir is anchoring multiple ongoing early and late-stage clinical trials of two-drug regimens in combination with other Merck antiretrovirals for potential treatments for HIV-1. Islatravir is being studied in Phase 3 in combination with Merck’s doravirine (DOR/ISL) as a once-daily pill for treatment of HIV-1 infection in adults with no prior antiviral treatment history and in Phase 2b in combination with Merck’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) ulonivirine (MK-8507) as an oral once-weekly treatment for HIV-1. For an overview of Merck’s HIV treatment and prevention clinical development program, please click here. About Gilead HIV For almost 40 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV prevention medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic worldwide. Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Merck’s Commitment to HIV For 40 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV. We are researching for real life and want to ensure people are not defined by HIV. Our work focuses on transformational innovations, collaborations with others in the global HIV community, and access initiatives aimed at helping to end the HIV epidemic for everyone. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Gilead Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving lenacapavir (such as ISLEND-1 and ISLEND-2); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, such as oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). BIKTARVY, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs. View source version on businesswire.com: https://www.businesswire.com/news/home/20260608276598/en/ GILEAD CONTACTS:
Priscilla White, Media
public_affairs@gilead.com Jacquie Ross, Investors
investor_relations@gilead.com MERCK CONTACTS:
Melissa Moody, Media
mediarelations@merck.com Damini Chokshi, Investors
investor_relations@merck.com Original: Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV Treatment
US Market News
4週前
Moderna and Merck Present 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA (pembrolizumab) in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection at the 2026 ASCO Annual MeetingJune 1, 2026 8:00 AM
ACCESS NewswireAt a median 5-year (60.3 months) planned follow-up of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA demonstrated a 49% reduction in the risk of recurrence or death and a 59% reduction in the risk of distant metastasis or death compared to KEYTRUDA aloneIntismeran autogene in combination with KEYTRUDA demonstrated an encouraging trend toward overall survival in an exploratory analysis compared to KEYTRUDA alone (HR=0.471; [95% CI, 0.165-1.345])CAMBRIDGE, MA AND RAHWAY, NJ / ACCESS Newswire / June 1, 2026 / Moderna, Inc. (NASDAQ:MRNA) and Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced detailed results from a planned five-year follow-up analysis of the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy (INT), in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with high-risk melanoma (stage III/IV) following complete resection. These data will be presented today at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29-June 2) and published simultaneously in ASCO's Journal of Clinical Oncology.With a median follow-up of 60.3 months (range, 50.5-76.4), adjuvant treatment with intismeran autogene in combination with KEYTRUDA continued to prolong recurrence-free survival (RFS), the study's primary endpoint, reducing the risk of recurrence or death by 49% (HR=0.51; [95% CI, 0.294-0.887]) compared to KEYTRUDA alone. Intismeran autogene in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival (DMFS), a key secondary endpoint of the study, reducing the risk of distant metastasis or death by 59% (HR=0.411; [95% CI, 0.200-0.843]) compared to KEYTRUDA alone. The exploratory endpoint of overall survival (OS) also demonstrated an encouraging trend toward improved OS (HR=0.471; [95% CI, 0.165-1.345]; n=14) with intismeran autogene in combination with KEYTRUDA compared to KEYTRUDA alone. Together, these findings indicate a sustained improvement in RFS and DMFS at five years."With each year of continued follow-up of our Phase 2b study, we gain a more complete picture of the durability of intismeran autogene in combination with KEYTRUDA. Now, with a median follow-up of five years, the sustained recurrence-free survival and distant metastasis-free survival demonstrate the potential long-term benefit of intismeran autogene in combination with KEYTRUDA in melanoma patients at high risk of recurrence," said David Berman, M.D., Ph.D., Chief Development Officer of Moderna. "These findings add to our confidence in the potentially transformative impact of this novel, personalized approach to cancer care made possible by mRNA technology.""The risk of disease recurrence remains high for patients with stage III/IV melanoma following surgery, so we are encouraged by these long-term findings showing that intismeran autogene in combination with KEYTRUDA provided sustained and durable reductions in the risk of recurrence," said Dr. Majorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. "These data further reinforce the potential of this individualized approach to address critical gaps in the adjuvant setting and reflect our continued commitment to advancing innovative therapies for patients."The safety profile of intismeran autogene in combination with KEYTRUDA remained consistent with prior analyses. The most common adverse events attributed to intismeran autogene in combination with KEYTRUDA were fatigue (59.6%), injection site pain (59.6%), and chills (51.0%). The majority of the adverse events attributed to intismeran autogene were Grade 1 (31.7%) and Grade 2 (51.9%), with fatigue being the most common Grade 3 event (4.8%) and no Grade 4-5 events. Immune-related adverse events occurred in 45.2% of patients receiving the combination and 44% receiving KEYTRUDA alone. Intismeran autogene in combination with KEYTRUDA did not result in potentiation of immune-related AEs.The findings build on the primary analysis and supportive analysis at an approximately three-year follow-up (34.9 months), presented at the 2024 ASCO Annual Meeting, in which intismeran autogene in combination with KEYTRUDA resulted in a 49% RFS risk reduction and 62% DMFS risk reduction compared to KEYTUDA alone.Additional subgroup and translational dataData from an exploratory subgroup analysis continued to indicate that improvement in RFS was maintained with intismeran autogene in combination with KEYTRUDA across subpopulations, including age, sex, disease state (Stage III/IV), programmed death-ligand 1 (PD-L1) status, BRAF status, tumor mutation burden (TMB) or circulating tumor DNA (ctDNA) status, compared to KEYTRUDA alone.Intismeran autogene plus KEYTRUDA increased T-cell clonal expansion and promoted the emergence of new T-cell clonotypes compared with KEYTRUDA alone. At long-term follow-up, patients receiving the combination demonstrated an approximately 2-fold higher proportion of novel expanded T-cell clonotypes versus KEYTRUDA monotherapy (0.030 vs 0.016 median summed frequency). Higher magnitude increases of these novel T-cell clones was associated with remaining recurrence-free; recurrence-free patients in the combination arm had approximately twice the number of unique novel expanded clonotypes at long-term follow-up (median number 42 vs 20 in recurrence-free vs recurrence patients, respectively). Additional data presented at ASCO (abstract #9564) found that, in a subset of melanoma patients receiving adjuvant combination therapy, these novel clonotypes were linked to intismeran-encoded neoantigens, supporting intismeran's proposed mechanism of action and association with clinical benefit.[1]Ongoing clinical development programsModerna and Merck have nine total Phase 2 and Phase 3 clinical trials underway investigating intismeran autogene in combination with KEYTRUDA across multiple tumor types, including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the recent initiation of a Phase 3 study of intismeran autogene as a monotherapy and in combination with KEYTRUDA for the treatment of high-risk Stage I NSCLC (INTerpath-014, NCT07513376).The Phase 3 clinical trial for adjuvant melanoma (INTerpath-001, NCT05933577) and a randomized Phase 2 study for adjuvant renal cell carcinoma (INTerpath-004, NCT06307431) are fully enrolled. Two NSCLC Phase 3 studies, evaluating adjuvant treatment in patients with completely resected NSCLC (INTerpath-002, NCT06077760) and evaluating adjuvant treatment for patients with resectable NSCLC after receiving neoadjuvant KEYTRUDA plus platinum-based chemotherapy (INTerpath-009, NCT06623422), are enrolling. Randomized Phase 2 studies for patients with resected muscle invasive bladder cancer (INTerpath-005, NCT06305767) and resected non-muscle invasive bladder cancer (INTerpath-011, NCT06833073) are enrolling, a Phase 2 study of first-line treatment for patients with metastatic melanoma (INTerpath-012, NCT06961006) and a Phase 2 study of first-line treatment for patients with metastatic squamous NSCLC (INTerpath-013, NCT07221474) are also enrolling.About intismeran autogene (mRNA-4157 or V940)Intismeran autogene is a novel investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) consisting of a synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient's tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity. Individualized neoantigen therapies are designed to train and activate an antitumor immune response by generating specific T-cell responses based on the unique mutational signature of a patient's tumor.About KEYNOTE-942/mRNA-4157-P201 (NCT03897881)KEYNOTE-942 is an ongoing randomized, open-label Phase 2b trial that enrolled 157 patients with high-risk stage III/IV melanoma. Following complete surgical resection, patients were assigned 2:1 (stratified by stage) to receive intismeran autogene (1 mg every three weeks for nine doses) and KEYTRUDA (200 mg every three weeks up to 18 cycles [for approximately one year]) versus KEYTRUDA alone for approximately one year until disease recurrence or unacceptable toxicity. The primary endpoint is RFS, defined as the time from first dose of KEYTRUDA until the date of first recurrence (local, regional or distant metastasis), a new primary melanoma, or death from any cause in the intention-to-treat population. Secondary endpoints include distant metastasis-free survival and safety, and exploratory endpoints include distribution of TMB expression in baseline tumor samples across study arms and their association with the primary RFS endpoint.Key eligibility criteria for the trial included: patients with resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence, patients with complete resection within 13 weeks prior to the first dose of KEYTRUDA, patients were disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases, patients had a formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing, Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 and patients with normal organ and marrow function reported at screening.About melanomaMelanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with more than 330,000 new cases diagnosed worldwide in 2022. In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be about 112,000 new cases of melanoma diagnosed and over 8,500 deaths resulting from the disease in the U.S. in 2026.About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mgKEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.MelanomaKEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information.Selected Important Safety Information for KEYTRUDASevere and Fatal Immune-Mediated Adverse ReactionsKEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti-PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.Immune-Mediated PneumonitisKEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.Immune-Mediated ColitisKEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (
US Market News
1月前
FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients with Newly Diagnosed Metastatic KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC)May 29, 2026 6:45 AM
Business Wire First Breakthrough Therapy designation for calderasib, supported by positive data from the Phase 1 KANDLELIT-001 trial Calderasib is an investigational, highly potent and specific next-generation KRAS G12C covalent inhibitor Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and expressing PD-L1 (tumor proportion score [TPS] ≥1%). This is the first Breakthrough Therapy designation for calderasib and was supported by positive data from the Phase 1 KANDLELIT-001 trial. “As our understanding of cancer biology and precision medicine continues to advance, we’re encouraged by the potential of new approaches, like calderasib, to help address the underlying drivers of cancer growth,” said Dr. Shweta Jain, vice president, global clinical development, Merck Research Laboratories. “The Breakthrough Therapy designation for calderasib underscores the promising potential of this medicine and unmet need for certain patients with KRAS G12C-mutated NSCLC.” The KRAS G12C mutation is the most frequently observed KRAS mutation in patients, occurring in approximately 14% of patients with NSCLC (adenocarcinoma). The FDA’s Breakthrough Therapy designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions. To qualify for this designation, preliminary clinical evidence must indicate that the product may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. The benefits of this Breakthrough Therapy designation include more intensive guidance from the FDA on an efficient development program, organizational commitment involving senior managers and experienced review staff, rolling review and potential eligibility for Priority Review. The KANDLELIT clinical development program for calderasib includes five Phase 3 trials across a range of tumor types and stages, including: KANDLELIT-004, evaluating calderasib in combination with KEYTRUDA for patients with newly diagnosed metastatic NSCLC with KRAS G12C-mutation and PD-L1 TPS ≥50%. KANDLELIT-007, evaluating calderasib in combination with KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in patients with newly diagnosed advanced or metastatic nonsquamous NSCLC with KRAS G12C-mutation, regardless of PD-L1 expression. KANDLELIT-012, evaluating calderasib in combination with cetuximab and mFOLFOX6 for the first-line treatment of certain patients with locally advanced unresectable or metastatic CRC who have KRAS G12C-mutated tumors. KANDLELIT-013, evaluating calderasib in combination with KEYTRUDA QLEX for certain patients with locally advanced KRAS G12C-mutated NSCLC following receipt of either neoadjuvant KEYTRUDA plus chemotherapy or adjuvant chemotherapy. KANDLELIT-015, evaluating calderasib in combination with durvalumab in certain patients with locally advanced, KRAS G12C-mutated NSCLC after chemotherapy and radiation therapy. Calderasib is being developed through a collaboration with Taiho Pharmaceutical Co. Ltd. and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. This collaboration was announced in January 2020. About calderasib
Calderasib (MK-1084) is an investigational, highly potent and specific next-generation KRAS G12C covalent inhibitor. Mutations in KRAS are among the most prevalent mutations found in cancer, occurring with high frequency in non-small cell lung cancer (NSCLC), pancreatic, urogenital and colorectal cancers. The KRAS G12C mutation is the most frequently observed KRAS mutation in patients, occurring in approximately 14% of patients with NSCLC (adenocarcinoma). Despite decades of research and recognition of the therapeutic importance of targeting KRAS, the development of small molecule inhibitors targeting KRAS mutations has been challenging. About lung cancer
Lung cancer is the leading cause of cancer death worldwide. In 2022 alone, there were approximately 2.4 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80% of all cases. In 2025, the overall five-year survival rate for patients diagnosed with lung cancer was nearly 30% in the United States. Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. Early detection and screening remain an important unmet need, as 43% of lung cancer cases are not found until they are advanced. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. About KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use, 165 mg + 2,000 units/mL
KEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL). Selected KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Indications in the U.S. Non-Small Cell Lung Cancer KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, for the first-line treatment of adult patients with metastatic squamous NSCLC. KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the first-line treatment of adult patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA or KEYTRUDA QLEX. KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Colorectal Cancer KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Safety Information for KEYTRUDA and KEYTRUDA QLEX Contraindications KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA and KEYTRUDA QLEX are monoclonal antibodies that belong to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA or KEYTRUDA QLEX in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA and KEYTRUDA QLEX depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA and KEYTRUDA QLEX require interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Immune-mediated pneumonitis occurred in 5% (13/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including fatal (0.4%), Grade 3 (2%), and Grade 2 (1.2%) adverse reactions. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (
US Market News
1月前
Merck Announces TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (Sac-TMT) Met Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Advanced or Recurrent Endometrial CancerMay 18, 2026 6:45 AM
Business Wire Sac-TMT is the first TROP2 ADC to improve OS and PFS compared to chemotherapy in patients with advanced or recurrent endometrial cancer who have progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy in a global Phase 3 study Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the pivotal Phase 3 TroFuse-005 trial evaluating sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, met its primary endpoints of overall survival (OS) and progression-free survival (PFS) in certain patients with advanced or recurrent endometrial cancer. TroFuse-005 is the first global Phase 3 trial to demonstrate statistically significant improvement in both OS and PFS compared to chemotherapy for these patients and the first and only ADC to do so for patients with endometrial cancer in this setting. At a pre-specified interim analysis, sac-TMT demonstrated a statistically significant and clinically meaningful improvement in OS and PFS compared to treatment of physician’s choice (TPC, consisting of doxorubicin or paclitaxel) for patients with endometrial cancer who have previously received platinum-based chemotherapy and anti-PD-1/L1 immunotherapy either together or separately. The study also reached its key secondary endpoint of objective response rate. These data will be presented at an upcoming medical meeting and discussed with regulatory authorities worldwide. The safety profile was consistent with what has been observed in previously reported studies of sac-TMT; no new safety signals were observed. “These results show sac-TMT may be able to address a critical unmet need for certain patients with advanced endometrial cancer, one of the only cancers increasing in both incidence and mortality worldwide,” said Dr. Domenica Lorusso, the study’s global lead investigator, lead investigator for ENGOT and professor of Obstetrics and Gynecology at Humanitas University and Humanitas San Pio X, Milan. “Despite recent advances, patients whose disease progresses following treatment with platinum and immunotherapy are urgently in need of new options, and these findings show for the first time that a TROP2 ADC may be an effective option in this setting.” “The scale and ambition of our expansive TroFuse program reflects our deep commitment to advancing one of the industry’s leading ADC pipelines to make a difference for more people facing cancer and builds on our legacy of leadership in gynecologic cancer research,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “These findings reinforce our belief that sac-TMT, with its proprietary bifunctional linker designed with the intent to maximize payload delivery to tumors while minimizing impact on healthy cells in the body, has the potential to become a cornerstone in the treatment of certain patients with advanced endometrial cancer. We thank the patients and investigators for participating in our studies as well as our collaborators at Kelun-Biotech for helping us advance this important treatment.” TroFuse-005 also marks the first positive Phase 3 results from Merck’s TroFuse clinical development program for sac-TMT. The program currently consists of 17 ongoing global Phase 3 trials across multiple tumor types, the broadest range of disease and treatment settings compared to any TROP2-directed ADC to date, including 10 Phase 3 trials in women’s cancers. The program is evaluating sac-TMT across a diverse range of tumor types, including endometrial, bladder, breast, cervical, gastric, non-small cell lung and ovarian cancers, and it spans early-to-late-stage disease as both monotherapy and in combination with immunotherapies. This includes the ongoing TroFuse-033 trial in first line mismatch repair proficient endometrial cancer. About TroFuse-005 TroFuse-005 is a randomized, active-controlled, open-label, multicenter, global Phase 3 trial (ClinicalTrials.gov, NCT06132958) evaluating sac-TMT versus TPC in patients with endometrial carcinoma and carcinosarcoma who have received prior platinum-based chemotherapy and anti-PD-1/anti-PD-L1 immunotherapy either together or separately. The trial enrolled 776 patients who were randomized to receive either sac-TMT or TPC, consisting of doxorubicin or paclitaxel. Sac-TMT (4 mg/kg) was administered on Day 1 of each two-week treatment cycle. Doxorubicin (60 mg/m²) was administered on Day 1 of each three-week treatment cycle and paclitaxel (80 mg/m²) was administered on Days 1, 8 and 15 of each four-week treatment cycle. The study has dual primary endpoints: PFS by blinded independent central review (BICR), defined as the time from randomization to the first documented disease progression or death from any cause, and OS, defined as the time from randomization to death from any cause. A key secondary endpoint is objective response rate, and other secondary endpoints include duration of response, incidence of adverse events, treatment discontinuation due to adverse events and change from baseline in global health status/quality-of-life scores. About sacituzumab tirumotecan (sac-TMT) Sac-TMT is an investigational TROP2-directed ADC with a belotecan-derived topoisomerase I inhibitor payload and a bifunctional linker designed with the potential to maximize payload delivery to tumor cells and minimize payload loss while circulating in the body. Sac-TMT is the only TROP2 ADC designed with a focus on both ends of the linker. TROP2 is overexpressed on tumor cells compared to healthy cells in many common cancers, and through the TroFuse clinical development program, Merck is evaluating sac-TMT in 17 ongoing global Phase 3 trials across multiple tumor types, the broadest range of disease and treatment settings compared to any TROP2-directed ADC to date. The TroFuse development program spans early-to-late-stage disease in more than nine disease areas and includes more than 15,000 patients worldwide. Numerous Phase 3 trials are exploring sac-TMT as monotherapy and in combination with immunotherapies, aiming to improve survival and quality of life for patients with advanced and earlier-stage cancers. About endometrial cancer Endometrial cancer (also referred to as endometrial carcinoma) begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus. More than 90% of uterine body cancers occur in the endometrium. In the U.S., it is estimated there will be approximately 68,270 patients diagnosed with endometrial cancer and approximately 14,450 patient deaths from the disease in 2026. Globally, endometrial cancer is the sixth most common cancer in women and the 15th most common cancer overall. Following primary treatment, patients face a risk of their cancer returning, often as distant metastasis, which is associated with poorer outcomes. About Merck’s research in women’s cancers Merck is advancing research aimed at expanding treatment options for certain breast and gynecologic (ovarian, cervical and endometrial) cancers, with a goal of improving outcomes for more patients affected by these diseases. Breast cancer and gynecologic cancers are the first and second most commonly occurring cancer types among women worldwide, respectively, and Merck aims to provide options to patients facing these devastating diseases. With more than 20 clinical trials in nearly 20,000 patients around the world, Merck is driving innovative research to purposefully advance standards of care in women’s cancers. Merck’s research efforts include trials focused on evaluating its medicines in earlier stages, as well as identifying novel mechanisms and new combinations with these treatments. Through our portfolio and pipeline, Merck is working to address the impact of women’s cancers on patients, their families and communities globally. About the Merck and Kelun-Biotech strategic collaboration Sac-TMT was developed by Kelun-Biotech. Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Under a collaboration agreement, Kelun-Biotech has granted Merck the exclusive rights to develop, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macau and Taiwan). Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). View source version on businesswire.com: https://www.businesswire.com/news/home/20260518302676/en/ Media Contacts: Julie Cunningham
julie.cunningham@merck.com John Infanti
john.infanti @Edwin48 Steven Graziano
(732) 594-1583 Original: Merck Announces TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (Sac-TMT) Met Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Advanced or Recurrent Endometrial Cancer
US Market News
2月前
Next-Generation GLP-1 Innovation Could Unlock Massive Metabolic Healthcare Market OpportunitiesMay 13, 2026 9:00 AM
InvestorsHub NewsWireNext-Generation GLP-1 Innovation Could Unlock Massive Metabolic Healthcare Market OpportunitiesBioMedWire Editorial Coverage: Obesity and type 2 diabetes mellitus ("T2DM") rank among the most urgent and costly healthcare problems facing the world today, contributing to surging rates of cardiovascular disease, fatty liver disease, kidney complications and ballooning healthcare expenses. What once represented a specialized class of diabetes treatments has grown into one of the most consequential therapeutic categories in modern medicine, with GLP-1 receptor agonists now fundamentally restructuring how obesity, metabolic disease and potentially even neurodegeneration are treated. Operating in this environment is SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) (Profile), which through its subsidiary GlucaPharm Inc. is developing a distinct next-generation GLP-1 platform built around GEP-44, a novel triple agonist peptide engineered to improve efficacy, tolerability, and delivery flexibility within one of the most commercially dynamic pharmaceutical markets in history. SureNano is one of the emerging microcap companies active in the GLP-1 space, operating alongside established leaders including Merck & Co. Inc. (NYSE: MRK), AbbVie Inc. (NYSE: ABBV), Viking Therapeutics Inc. (NASDAQ: VKTX) and Altimmune Inc. (NASDAQ: ALT).SureNano Science is developing GEP-44 as a patented next-generation metabolic therapy designed to address the limitations of first-generation GLP-1 drugs.The commercial potential tied to GLP-1 therapies is expanding quickly, with the global GLP-1 market forecast to potentially reach $190 billion by 2035.SureNano Science is also eyeing differentiated drug-delivery technologies designed to improve patient accessibility and long-term adherence.Preclinical data from SureNano Science suggest that GEP-44 may offer substantive differentiation relative to earlier-generation GLP therapies.Beyond its primary GLP-1 metabolic platform, SureNano Science is also evaluating early-stage opportunities that could expand the long-term scope of its therapeutic and delivery technology portfolio.Click here to view the custom infographic of the SureNano Science editorial. Rewriting the Rules of Metabolic MedicineThe global obesity crisis shows no sign of plateauing. According to the World Health Organization ("WHO"), a reported one billion people globally are currently living with obesity, while type 2 diabetes rates continue to climb across both high-income and developing economies. The WHO further notes that obesity increases the risk of cardiovascular disease, stroke and T2DM, while further research has linked obesity to chronic kidney disease and rising healthcare expenditures, placing substantial and growing pressure on health systems around the world.GLP-1 receptor agonists have rapidly risen to become one of the defining breakthroughs in metabolic medicine. Originally introduced to manage blood glucose levels in diabetes patients, these drugs are now recognized for their capacity to drive meaningful weight reduction and deliver broad improvements in metabolic health. Market leaders Novo Nordisk A/S and Eli Lilly and Company have come to dominate the space through their blockbuster injectable franchises, including Ozempic(R), Wegovy(R), Mounjaro(R) and Zepbound(R).Commercial momentum in this space is increasing. JPMorgan Chase & Co. forecasts that the general obesity drug market could reach $200 billion by 2030 as global adoption expands and indications stretch beyond diabetes and weight management. Additional industry projections suggest GLP-1 therapies are on track to become one of the most commercially successful drug categories ever, with annual sales projections of $150 billion or more by the end of the decade.The industry is already pivoting toward the next generation of incretin therapies, with a focus on improved efficacy, tolerability and patient convenience. Needle-free, including oral, formulas, expanded indications and combination metabolic approaches have emerged as major priorities across the sector. SureNano Science is positioning itself in this scenario as a nimble participant pursuing differentiated innovation through GEP-44, a patented triple agonist peptide licensed from Syracuse University and designed to advance through the U.S. Food and Drug Administration ("FDA") regulatory route.A Next-Gen Candidate Built for Better OutcomesSureNano Science is developing GEP-44 as a patented next-generation metabolic therapy designed to address the limitations of first-generation GLP-1 drugs, positioning this up-and-coming microcap as a small but strategically focused company moving through the FDA process. Unlike traditional GLP-1 agonists, which act on a single receptor pathway, GEP-44 functions as a triple agonist targeting GLP-1 alongside peptide YY receptors Y1 and Y2. This combined mechanism is designed to simultaneously regulate glucose metabolism, reduce appetite and improve tolerability within a single therapeutic molecule.The compound originated at Syracuse University and has generated promising results in preclinical settings. According to research, GEP-44 produced meaningful reductions in food intake and decreased body weight while also enhancing glycemic control in preclinical models. In addition, the compound did not trigger the nausea, malaise and gastrointestinal adverse effects commonly seen with many first-generation GLP-1 therapies, a distinction that could become increasingly significant as patient populations and adherence demands grow.The broader pharmaceutical industry is investing aggressively in incretin therapies that can address tolerability and long-term adherence challenges. PwC reports that the next segment of the obesity drug market will most likely be characterized by expanded indications, more patient-friendly delivery formats and therapies with stronger adherence profiles. This lends itself to a supportive environment for companies pursuing second-generation GLP innovation.Despite being smaller than more-established pharmaceutical players, SureNano Science operates with a lean development model and cost-efficient structure built for flexibility and development speed. The company is involved in substantial research in Australia, where government incentive programs may provide research tax credits of up to 43.5% on qualifying expenditures. Should GEP-44 continue producing favorable results through clinical development, the company could emerge as an attractive acquisition, licensing or partnership candidate within the fast-expanding GLP ecosystem.Market Scale and the Commercial Case for GLP-1 InnovationThe commercial potential tied to GLP-1 therapies is expanding quickly. According to Morgan Stanley, the global GLP-1 market could reach $190 billion by 2035 as patient adoption broadens and therapeutic applications extend into new disease areas. Industry forecasts from BCC Research also forecast significant long-term growth, with the GLP-1 analogue market estimated to reach $268.4 billion by 2030.Patient uptake estimates that between 25 and 30 million Americans could be using GLP-1 therapies by 2030, up from approximately 10 million in 2026. Increasing insurance coverage along with obesity prevalence and growing physician familiarity are all driving the rapid mainstreaming of these treatments.At the same time, the competitive setting is shifting toward the next wave of products. IQVIA calls 2026 the "year of the orals," with oral GLP-1 formulations projected to meaningfully enhance accessibility, compliance and long-term maintenance therapy adoption. The anticipated off-patent expansion of semaglutide across major global markets is also expected to intensify competition while broadening overall patient access.As GEP-44 advances through IND-enabling studies and moves toward eventual phase 1 trials, SureNano Science stands as one of a small number of microcap public companies offering direct exposure to the expanding GLP-1 market. This positioning may represent a meaningful valuation gap relative to large-cap pharmaceutical incumbents and late-stage obesity therapy developers, particularly if the company achieves key clinical and regulatory milestones.Delivery Innovation as a Second Engine of ValueAlongside its core therapeutic development efforts, SureNano Science is also eyeing differentiated drug-delivery technologies designed to improve patient accessibility and long-term adherence. The company's platform strategy includes evaluating oral, sublingual and intranasal delivery approaches that could eventually reduce reliance on injectable administration.Convenience and adherence have emerged as increasingly important competitive dimensions within the GLP-1 market. The dominant therapies today are injection-based, creating barriers for some patients due to administration complexity, refrigeration requirements and long-term compliance challenges. Noninvasive and oral alternatives are widely regarded as representing one of the most significant near-term commercial opportunities in obesity and diabetes treatment.Industry analysts increasingly view delivery innovation as potentially as consequential as efficacy improvements. IQVIA notes that oral obesity therapies could substantially boost long-term maintenance adoption while simplifying supply chains by removing cold-chain requirements, factors that could meaningfully expand patient access in international markets.By combining therapeutic development with delivery innovation, SureNano Science is working to build a vertically integrated metabolic disease platform rather than advancing a single injectable drug candidate. This broader strategy may generate additional long-term optionality and commercial flexibility as the obesity treatment market continues to evolve.Preclinical Data Point to a Meaningful Competitive EdgePreclinical data from SureNano Science suggest that GEP-44 may offer substantive differentiation relative to earlier-generation GLP therapies. According to the company, the compound demonstrated approximately 15% weight loss in preclinical testing, compared with roughly 9% observed with liraglutide, while food intake reductions reached approximately 39% versus around 20% for the comparator.In addition to weight reduction, GEP-44 produced improvements in glycemic control while reportedly avoiding nausea and vomiting during testing. Gastrointestinal side effects remain among the most frequently cited challenges associated with currently marketed GLP-1 therapies and represent a significant driver of discontinuation. Improved tolerability could therefore become a meaningful competitive advantage if these preclinical findings are validated in human studies.The pharmaceutical industry continues to pour resources into next-generation obesity therapies capable of delivering better outcomes and patient experiences. The Pharma Letter reports that obesity drug pipelines are increasingly oriented toward differentiation through combination receptor pathways, improved tolerability profiles, and expanded delivery options as the competitive field intensifies.While GEP-44 remains in preclinical development, these early findings place SureNano Science within a strategically important segment of the obesity treatment landscape. If subsequent studies continue to support these results, the company could establish itself as a distinctive participant in one of the largest and most rapidly expanding therapeutic categories in contemporary healthcare.Exploring Broader Platform Opportunities for Long-Term GrowthBeyond its primary GLP-1 metabolic platform, SureNano Science is also evaluating early-stage opportunities that could expand the long-term scope of its therapeutic and delivery technology portfolio. These discussions include nonbinding opportunities involving ibogaine-related intellectual property concentrated on formulation and delivery technologies.While still exploratory and not considered a core asset at this stage, the initiative reflects a broader strategic aim of building diversified platform capabilities across multiple high-growth therapeutic areas. Scientific and investor interest in ibogaine and related psychedelic-derived therapeutics has grown considerably in recent years, as researchers examine their potential applications in addiction treatment, mental health conditions, and neurological disorders.CNN recently reported on the growing scientific and regulatory attention being directed at ibogaine research, particularly in areas related to opioid addiction and treatment-resistant mental health conditions. The U.S. Food and Drug Administration has also signaled increasing openness to accelerating development pathways for treatments targeting serious mental illnesses and areas of significant unmet medical need.SureNano's interest in formulation and delivery technologies within these emerging areas fits naturally with the company's broader emphasis on drug-delivery innovation and platform versatility. Rather than treating ibogaine-related opportunities as a standalone commercial priority, the company appears to be assessing how specialized delivery technologies and intellectual property could complement its existing capabilities in metabolic therapeutics and nontraditional administration. This kind of optionality may provide incremental long-term strategic value if the regulatory landscape surrounding psychedelic-based therapies continues to evolve.These initiatives remain early stage and are subject to meaningful scientific, clinical and regulatory uncertainty. However, by selectively evaluating expansion opportunities alongside its primary GLP-1 development program, SureNano Science is aligning itself with a broader trend toward diversified therapeutic platforms capable of competing across multiple large and evolving healthcare markets. As pharmaceutical innovation increasingly converges around metabolic health, neuroscience, and advanced delivery technologies, strategic flexibility may prove to be a growing differentiator for emerging biotechnology companies.Advances Continue Across the GLP-1 LandscapeMomentum across the GLP-1 and metabolic disease sector continues to accelerate as leading biotechnology and pharmaceutical companies expand development programs targeting obesity, diabetes, liver disease and broader cardiometabolic conditions. Recent news from the GLP-1 space highlights continued investment in next-generation therapies, late-stage clinical development, strategic partnerships and regulatory progress as the rapidly evolving space remains one of the most closely watched areas in healthcare and biotechnology.Merck & Co. Inc. (NYSE: MRK) expanded into the GLP-1 and obesity-treatment market through an exclusive global licensing agreement with Hansoh Pharma for an investigational oral GLP-1 receptor agonist. Merck stated that the candidate is being developed for cardiometabolic diseases and described the agreement as part of the company's strategy to strengthen its presence in metabolic disorders. The company noted that it will receive exclusive rights outside China to develop, manufacture and commercialize the therapy, reflecting a growing industry focus on oral GLP-1 treatments for obesity and related conditions.AbbVie Inc. (NYSE: ABBV) announced positive topline results from a phase 1 multiple ascending dose study evaluating ABBV-295, its long-acting amylin analog being developed for obesity and metabolic disease treatment. AbbVie reported that ABBV-295 demonstrated "clinically meaningful" body weight reduction ranging from approximately 7.75% to 9.79% over the treatment period, while also showing a "favorable tolerability profile" with no serious adverse events reported. The company emphasized that the data support continued advancement of its metabolic disease pipeline amid increasing interest in next-generation obesity therapies that may complement or compete with GLP-1 drugs.Viking Therapeutics Inc. (NASDAQ: VKTX) reported completion of enrollment in its phase 3 VANQUISH-2 trial evaluating VK2735, its dual GLP-1/GIP receptor agonist candidate for obesity treatment. Viking stated that the study is assessing subcutaneous VK2735 in adults with obesity and type 2 diabetes, while concurrent phase 3 development is also ongoing in broader obesity populations. The company noted that VK2735 is being developed in both oral and injectable formulations for metabolic disorders, underscoring its position in the rapidly expanding GLP-1 obesity-treatment landscape.Altimmune Inc. (NASDAQ: ALT) announced that pemvidutide received FDA Breakthrough Therapy designation for the treatment of MASH, further advancing development of the company's GLP-1/glucagon dual receptor agonist platform. Altimmune stated that pemvidutide has demonstrated improvements in liver fat reduction, weight loss and fibrosis-related measures, while the company plans to initiate a Phase 3 trial evaluating multiple doses over a 52-week treatment period. The announcement reinforces Altimmune's ongoing efforts to position pemvidutide within the broader GLP-1 and metabolic disease sector spanning obesity, liver disease and related cardiometabolic conditions.Collectively, these developments underscore the growing importance of GLP-1-related therapies as companies compete to address some of the world's largest and fastest-growing chronic health challenges. With ongoing advances in oral formulations, combination therapies and expanded metabolic disease applications, the sector continues to attract significant scientific, clinical and investor attention while reshaping the future landscape of obesity and cardiometabolic treatment.For further information about SureNano Science Ltd., visit the SureNano Science profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. 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2月前
Merck Highlights New Long-Term Data and Advancements Across Broad Oncology Portfolio and Pipeline Research at ASCO 2026May 12, 2026 6:45 AM
Business Wire Five-year follow-up data from KEYNOTE-942 underscore the continued potential of intismeran autogene (mRNA-4157 or V940) in combination with KEYTRUDA® (pembrolizumab) for patients with resected high-risk melanoma Results from the final analysis of KEYNOTE-522, evaluating KEYTRUDA in combination with chemotherapy, demonstrate continued survival benefit for patients with high-risk early-stage triple-negative breast cancer (TNBC) New data for sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate, add to ongoing research of novel treatment approaches for patients with non-small cell lung cancer Data from ASCENT-04/KEYNOTE-D19, evaluating KEYTRUDA plus Trodelvy® (sacituzumab govitecan-hziy) for patients with metastatic TNBC, will be featured in the official ASCO 2026 Press Program Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new research from more than 100 abstracts across over 25 types of cancer from the company’s comprehensive oncology portfolio and pipeline will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29-June 2). The data reinforce the long-term impact of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, and Merck’s rapidly advancing pipeline across multiple tumor types and stages of disease, highlighting the company’s leadership in oncology and commitment to advancing innovative oncology research. “During ASCO, we will present data that showcase the strong momentum in our oncology pipeline, including long-term data for intismeran autogene, our investigational individualized neoantigen therapy (INT),” said Dr. Marjorie Green, senior vice president and head of oncology global clinical development, Merck Research Laboratories. “We look forward to sharing new research for our oncology medicines and novel treatment approaches, such as our INT and antibody-drug conjugates, which may help address significant unmet medical needs for patients living with cancer.” Key data from Merck’s portfolio and pipeline to be presented: Five-year follow-up data from the Phase 2b KEYNOTE-942 trial evaluating intismeran autogene in combination with KEYTRUDA for patients with high-risk melanoma following complete resection (Abstract #9500, Oral abstract session: Melanoma/skin cancers).1 Final analysis results from the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA in combination with chemotherapy as pre-operative treatment and then continuing as a single agent after surgery for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) (Abstract #507, Oral abstract session: Breast cancer – local/regional/adjuvant). Data from the Phase 3 OptiTROP-Lung05 trial conducted in China, led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA in advanced non-small cell lung cancer (Abstract #8506, Oral abstract session: Lung cancer – non-small cell metastatic).2 Progression-free survival data from the Phase 3 ASCENT-04/KEYNOTE-D19 study evaluating KEYTRUDA plus Trodelvy (sacituzumab govitecan-hziy) in previously untreated PD-L1-positive metastatic TNBC ??(Abstract #LBA1000, Oral abstract session: Breast cancer – metastatic).?3 Merck investor event Merck will hold an Oncology Investor Event to coincide with the 2026 ASCO Annual Meeting on Monday, June 1, 2026, 6 p.m. CT, during which senior management will provide an update on the company’s oncology strategy and program. The event will take place in Chicago, Ill., and will be accessible via webcast. Investors, analysts, members of the media and the general public are invited to listen to a webcast of the presentation via this weblink. All participants may join the call by dialing (800) 369-2154 (U.S. and Canada Toll-Free) or (517) 308-9422 and using the access code 8711041. Details on abstracts listed above and additional key abstracts for Merck Breast cancer Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Final analysis results from the Phase 3 KEYNOTE-522 study. P. Schmid. Abstract #507, Oral abstract session:
Breast cancer – local/regional/adjuvant Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-04 study of participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) plus pembrolizumab (pembro) vs chemotherapy (chemo) plus pembro. K. Kalinsky.?3 Abstract #LBA1000, Oral abstract session:
Breast cancer – metastatic Gastrointestinal cancers KEYNOTE-811: 6-year median follow-up of pembrolizumab plus trastuzumab and chemotherapy for previously untreated advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma. A. Kawazoe. Abstract #4040, Poster session:
Gastrointestinal cancer – gastroesophageal, pancreatic and hepatobiliary Genitourinary cancers Enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): 3.5-year follow-up and response analyses from the Phase 3 EV-302 study. T. Powles.4 Abstract #4507, Oral abstract session:
Genitourinary cancer – kidney and bladder Extended follow up (6-years) of the Phase 2 LITESPARK-004 study of belzutifan in participants with von Hippel-Lindau disease-associated neoplasms. R. Srinivasan. Abstract #4550, Poster session:
Genitourinary cancer – kidney and bladder Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible: Phase 3 KEYNOTE-905 study. P. O’Donnell.4 Abstract #4510, Clinical science symposium:
New approaches to curing bladder and kidney cancer Health-related quality of life (HRQoL) with pembrolizumab or observation for high-risk muscle-invasive urothelial carcinoma after surgery: Results from the AMBASSADOR randomized trial (Alliance A031501). R. Chen.?5 Abstract #4513, Oral abstract session:
Genitourinary cancer – kidney and bladder Belzutifan in docetaxel-pretreated metastatic castration-resistant prostate cancer (mCRPC): Phase 1b/2 KEYNOTE-365 cohort J. J. Arranz.? Abstract #5058, Poster session:
Genitourinary cancer – prostate, testicular and penile Gynecologic cancers Updated overall survival analysis and examination of subsequent therapy in endometrial cancer (EC) patients (pts) treated with pembrolizumab plus carboplatin/paclitaxel (CP) as compared to CP plus placebo (PBO) in the NRG-GY018 trial. R. Eskander.6 Abstract #5502, Oral abstract session:
Gynecologic cancer Exposure-response (E-R) analyses of efficacy and safety with raludotatug deruxtecan (R-DXd), a CDH6-directed antibody-drug conjugate (ADC), to inform dose selection for Phase (Ph) 3 development in platinum-resistant ovarian cancer (PROC). F. Hurtado.7 Abstract #5570, Poster session:
Gynecologic cancer Lung cancer Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus pembrolizumab(P) as first-line treatment for PD-L1-positive advanced non-small cell lung cancer (NSCLC): Results from the randomized Phase 3 OptiTROP-Lung05 study. C. Zhou.?2 Abstract #8506, Oral abstract session:
Lung cancer – non-small cell metastatic Melanoma Individualized neoantigen therapy intismeran autogene (intismeran) plus pembrolizumab (pembro) in resected melanoma: 5-year update of the KEYNOTE-942 study. M. Carlino.?1 Abstract #9500, Oral abstract session:
Melanoma/skin cancers Biomarkers Development and evaluation of a novel digital pathology image analysis pipeline for prediction of clinical outcomes with the TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in triple-negative breast cancer (TNBC). S. Tolaney.? Abstract #1026, Poster session:
Breast cancer – metastatic 1 In collaboration with Moderna
2 Led by Kelun-Biotech, conducted in China
3 In collaboration with Gilead. Trodelvy is a registered trademark of Gilead Sciences, Inc., or its related companies.
4 In collaboration with Astellas/Pfizer
5 Sponsored by U.S. National Cancer Institute (NCI)/led by Alliance for Clinical Trials in Oncology
6 Sponsored by U.S. National Cancer Institute (NCI)/led by NRG Oncology
7 In collaboration with Daiichi Sankyo About intismeran autogene (mRNA-4157 or V940) Intismeran autogene is a novel investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) consisting of a synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient’s tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity. Individualized neoantigen therapies are designed to train and activate an antitumor immune response by generating specific T-cell responses based on the unique mutational signature of a patient’s tumor. About sacituzumab tirumotecan (sac-TMT) Sac-TMT is an investigational TROP2-directed ADC with a belotecan-derived topoisomerase I inhibitor payload and a bifunctional linker designed with the potential to maximize payload delivery to tumor cells and minimize payload loss while circulating in the body. Sac-TMT is the only TROP2 ADC designed with a focus on both ends of the linker. TROP2 is overexpressed on tumor cells compared to healthy cells in many common cancers, and through the TroFuse clinical development program, Merck is evaluating sac-TMT in 17 ongoing global Phase 3 trials across multiple tumor types, the broadest range of disease and treatment settings compared to any TROP2-directed ADC to date. The TroFuse development program spans early-to-late-stage disease in more than nine disease areas and includes more than 15,000 patients worldwide. Numerous Phase 3 trials are exploring sac-TMT as monotherapy and in combination with immunotherapies, aiming to improve survival and quality of life for patients with advanced and earlier-stage cancers. About raludotatug deruxtecan (R-DXd) Raludotatug deruxtecan is an investigational, potential first-in-class CDH6 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, raludotatug deruxtecan is comprised of a humanized anti-CDH6 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA® (pembrolizumab) Indications in the U.S. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test. Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. Ovarian Cancer KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Important Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (
US Market News
2月前
Merck & Co., Inc., Rahway, N.J., USA Announces First-Quarter 2026 Financial Results; Highlights Significant Regulatory Approvals and Clinical MilestonesApril 30, 2026 6:30 AM
Business Wire
Sales Growth Driven by Continued Strength in Oncology and Animal Health, Plus Increasing Contributions From Launches
Total Worldwide Sales Were $16.3 Billion (5% Growth; 3% Growth ex-FX)
KEYTRUDA/KEYTRUDA QLEX1 Sales Were $8.0 Billion (12% Growth; 8% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $128 Million
WINREVAIR Sales Were $525 Million (88% Growth; 87% Growth ex-FX)
Animal Health Sales Were $1.8 Billion (13% Growth; 6% Growth ex-FX)
GAAP Loss per Share Was $1.72; Non-GAAP Loss per Share Was $1.28; GAAP and Non-GAAP Loss per Share Include a Charge of $3.62 per Share for the Acquisition of Cidara
Presented New Data From Cardio-Pulmonary Pipeline at ACC.26, Including Positive Results From Phase 3 CORALreef AddOn Trial
Received U.S. FDA Approval for IDVYNSO, a Once-Daily, Oral Treatment for Certain Adults With Virologically Suppressed HIV-1
Achieved Multiple Significant Regulatory and Clinical Milestones Across Oncology Pipeline
Announced Agreement To Acquire Terns Pharmaceuticals, Inc. and Expand Hematology Pipeline With TERN-701, a Novel Candidate for Chronic Myeloid Leukemia; Transaction Expected To Close in May
Full-Year 2026 Financial Outlook
Narrows and Raises the Midpoint of Worldwide Sales Range; Now Expects Sales To Be Between $65.8 Billion and $67.0 Billion
Narrows and Raises Expected Non-GAAP EPS Range To Be Between $5.04 and $5.16
Outlook Does Not Reflect Any Impact From Proposed Acquisition of Terns Pharmaceuticals, Inc., Which Is Expected To Close in May and Result in a One-Time Charge of Approximately $5.8 Billion or Approximately $2.35 per Share
Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2026.
“We are moving with speed to transform our portfolio to one with a diversified set of growth drivers across a broad set of therapeutic areas,” said Robert M. Davis, chairman and chief executive officer. “During the first quarter, we continued to strengthen our pipeline with science-led business development, including our planned acquisition of Terns. We also achieved several important milestones, such as the FDA approval of IDVYNSO – which marks a new chapter in our longstanding commitment to people living with HIV. I am pleased with our progress and excited for what’s ahead, as we enter a particularly robust period of Phase 3 data readouts and deliver on the promise of our pipeline for patients.”
Financial Summary
$ in millions, except EPS amounts
First Quarter
2026
2025
Change
Change
Ex-
Exchange
Sales
$16,286
$15,529
5%
3%
GAAP net (loss) income2
(4,240)
5,079
N/M
N/M
Non-GAAP net (loss) income that excludes certain items2,3*
(3,156)
5,611
N/M
N/M
GAAP EPS
(1.72)
2.01
N/M
N/M
Non-GAAP EPS that excludes certain items3*
(1.28)
2.22
N/M
N/M
*Refer to table on page 7.
N/M - Not meaningful.
For the first quarter of 2026, Generally Accepted Accounting Principles (GAAP) loss / earnings per share (EPS) assuming dilution was a loss per share of $1.72 and non-GAAP loss per share was $1.28. Both the GAAP and non-GAAP loss per share were due to a charge for the acquisition of Cidara Therapeutics, Inc. (Cidara) of $3.62 per share.
Non-GAAP EPS excludes acquisition- and divestiture-related costs and costs related to restructuring programs, as well as income and losses from investments in equity securities.
First-Quarter Sales Performance
The following table reflects sales of the Company’s top products and significant performance drivers.
First Quarter
$ in millions
2026
2025
Change
Change
Ex-
Exchange
Commentary
Total Sales
$16,286
$15,529
5%
3%
Pharmaceutical
14,349
13,638
5%
2%
Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by declines in vaccines, diabetes and infectious diseases.
KEYTRUDA/ KEYTRUDA QLEX
8,034
7,205
12%
8%
Growth primarily driven by higher global demand in metastatic indications including urothelial cancer, as well as strong global uptake in earlier-stage indications, including triple-negative breast cancer, cervical cancer and renal cell carcinoma (RCC). Sales growth benefited from the timing of wholesaler purchases in the U.S. Sales of KEYTRUDA QLEX were $128 million.
GARDASIL/
GARDASIL 9
1,069
1,327
-19%
-22%
Decline primarily due to lower demand in China as well as lower sales in Japan following the national catch-up immunization program. Decline also reflects lower sales in the U.S. primarily due to unfavorable public-sector purchasing patterns, partially offset by higher net pricing.
JANUVIA/JANUMET
574
796
-28%
-29%
Decline primarily due to lower demand and net pricing in the U.S., as well as lower demand in China and most other international markets due to generic competition.
PROQUAD, M-M-R II and VARIVAX
538
539
0%
-2%
Sales were flat, primarily driven by unfavorable private sector purchasing patterns for M-M-R II and lower demand for M-M-R II and VARIVAX in the U.S., offset by higher PROQUAD sales in the U.S. due to borrowing of doses in 2025 from a U.S. government stockpile, which lowered sales in that period.
WINREVAIR
525
280
88%
87%
Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe.
BRIDION
472
441
7%
7%
Growth primarily due to higher demand in the U.S., partially offset by lower demand in most international markets due to ongoing generic competition.
Lynparza*
341
312
9%
6%
Growth primarily due to higher demand in the U.S. and many international markets.
PREVYMIS
272
208
31%
26%
Increase primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications.
Lenvima*
256
258
-1%
-2%
Relatively flat compared with prior year.
ROTATEQ
206
228
-10%
-11%
Decrease primarily driven by lower demand in China.
VAXNEUVANCE
202
230
-12%
-16%
Decrease primarily driven by lower demand in the U.S. and most international markets due to competitive pressure.
WELIREG
199
137
45%
43%
Growth primarily driven by higher demand in the U.S. and continued launch uptake in several international markets, particularly in Japan and certain European markets.
CAPVAXIVE
142
107
33%
31%
Increase primarily driven by launch uptake in certain European markets and continued uptake in the U.S. U.S. sales growth was partially offset by a reduction in wholesaler inventory.
OHTUVAYRE
131
-
-
-
Product obtained as part of the Company’s October 2025 acquisition of Verona Pharma plc (Verona Pharma).
LAGEVRIO
28
102
-73%
-73%
Decline largely due to lower demand in Japan and the U.S.
Animal Health
1,791
1,588
13%
6%
Growth attributable to performance in both Livestock and Companion Animal product portfolios.
Livestock
1,064
924
15%
8%
Growth primarily driven by higher demand for ruminant and poultry products as well as price.
Companion Animal
727
664
9%
4%
Growth from new product launches and price was partially offset by lower demand for other products in portfolio, reflecting a reduction in veterinary visits. Sales of BRAVECTO line of products were $379 million and $327 million in current and prior-year quarters, respectively, which represents an increase of 16%, or 9% excluding impact of foreign exchange.
Other Revenues**
146
303
-52%
4%
Decline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements, partially offset by higher milestones received for out-licensing arrangements and higher royalty income.
*Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs.
**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.
In addition, Koselugo alliance revenue was $161 million for the first quarter of 2026 compared with $44 million for the first quarter of 2025. The increase was due to a $150 million payment received in the first quarter of 2026 in connection with an amendment to the collaboration agreement with AstraZeneca in 2025, which (subject to an annual election by AstraZeneca) discontinued the provisions whereby the Company shared revenue and costs with AstraZeneca, and revised the payment structure.
First-Quarter Expense and Related Information
The table below presents selected expense information.
$ in millions
GAAP
Acquisition-
and
Divestiture-
Related Costs4
Restructuring
Costs
(Income)
Loss From
Investments
in Equity
Securities
Non-
GAAP3
First Quarter 2026
Cost of sales
$4,195
$1,014
$237
$ -
$2,944
Selling, general and administrative
2,700
32
-
-
2,668
Research and development
12,592
-
34
-
12,558
Restructuring costs
195
-
195
-
-
Other (income) expense, net
138
-
-
(180)
318
First Quarter 2025
Cost of sales
$3,419
$620
$36
$-
$2,763
Selling, general and administrative
2,552
23
-
-
2,529
Research and development
3,621
7
-
-
3,614
Restructuring costs
69
-
69
-
-
Other (income) expense, net
(35)
(3)
-
(107)
75
GAAP Expense, EPS and Related Information
Gross margin was 74.2% for the first quarter of 2026 compared with 78.0% for the first quarter of 2025. The decrease was primarily due to higher amortization of intangible assets, higher restructuring costs, the recognition of inventory fair value step-up related to the 2025 Verona Pharma acquisition and the unfavorable impact of foreign exchange, partially offset by favorable product mix.
Selling, general and administrative (SG&A) expenses were $2.7 billion in the first quarter of 2026, an increase of 6% compared with the first quarter of 2025. The increase was primarily due to higher administrative costs and the unfavorable impact of foreign exchange.
Research and development (R&D) expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of 2025. The increase was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending, the unfavorable impact of foreign exchange and restructuring costs, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone Life Sciences (Blackstone) and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 acquisition of EyeBiotech Limited (EyeBio).
Other (income) expense, net, was $138 million of expense in the first quarter of 2026 compared with $35 million of income in the first quarter of 2025. The unfavorability was primarily due to higher net interest expense, partially offset by higher net income from investments in equity securities.
The income tax provision for the first quarter of 2026 was $709 million on a pretax loss of $3.5 billion, resulting in an effective income tax rate of (20.1)%. This effective income tax rate includes a 33.1 percentage point unfavorable impact of the charge for the acquisition of Cidara, for which no tax benefit was recorded.
GAAP loss per share was $1.72 for the first quarter of 2026 compared with earnings per share of $2.01 for the first quarter of 2025, primarily driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara.
Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was 81.9% for the first quarter of 2026 compared with 82.2% for the first quarter of 2025. The decrease was primarily due to the unfavorable impact of foreign exchange, partially offset by favorable product mix.
Non-GAAP SG&A expenses were $2.7 billion in the first quarter of 2026, an increase of 5% compared with the first quarter of 2025. The increase was primarily due to higher administrative costs and the unfavorable impact of foreign exchange.
Non-GAAP R&D expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of 2025. The increase was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending and the unfavorable impact of foreign exchange, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 acquisition of EyeBio.
Non-GAAP other (income) expense, net, was $318 million of expense in the first quarter of 2026 compared with $75 million of expense in the first quarter of 2025. The unfavorability was primarily due to higher net interest expense.
The non-GAAP income tax provision for the first quarter of 2026 was $957 million on a pretax loss of $2.2 billion, resulting in a non-GAAP effective income tax rate of (43.5)%. This effective income tax rate includes a 57.6 percentage point unfavorable impact of the charge for the acquisition of Cidara, for which no tax benefit was recorded.
Non-GAAP loss per share was $1.28 for the first quarter of 2026 compared with earnings per share of $2.22 for the first quarter of 2025, primarily driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara.
A reconciliation of GAAP to non-GAAP net (loss) income and EPS is provided in the table that follows.
First Quarter
$ in millions, except EPS amounts
2026
2025
EPS
GAAP EPS
$(1.72)
$2.01
Difference
0.44
0.21
Non-GAAP EPS that excludes items listed below3
$(1.28)
$2.22
Net (Loss) Income
GAAP net (loss) income2
$(4,240)
$5,079
Difference
1,084
532
Non-GAAP net (loss) income that excludes items listed below2,3
$(3,156)
$5,611
Excluded Items:
Acquisition- and divestiture-related costs4
$1,046
$647
Restructuring costs
466
105
Income from investments in equity securities
(180)
(107)
Increase to net loss / decrease to net income before taxes
1,332
645
Estimated income tax benefit5
(248)
(113)
Increase to net loss / decrease to net income
$1,084
$532
Pipeline and Portfolio Highlights
In the first quarter, the Company continued to advance its pipeline, achieving significant regulatory and clinical milestones across a broad range of therapeutic areas.
Oncology:
U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX plus paclitaxel, with or without bevacizumab, for the treatment of certain adults with PD-L1+ (combined positive score [CPS] ≥1) platinum-resistant ovarian cancer, based on Phase 3 KEYNOTE-B96 trial.
The European Commission (EC) also approved this KEYTRUDA regimen for this population.
In April, FDA approved a label update for KEYTRUDA QLEX based on results from Phase 2 MK-3475A-F11 trial, which evaluated patient-reported preference for subcutaneous administration of KEYTRUDA QLEX over intravenous administration of KEYTRUDA in participants with multiple tumor types.
In April, FDA granted priority review for ifinatamab deruxtecan (I-DXd) for certain adults with previously treated extensive-stage small cell lung cancer, based on Phase 2 Ideate-Lung01 trial. I-DXd is part of the Company’s collaboration with Daiichi Sankyo.
FDA set Prescription Drug User Fee Act (PDUFA) date of Oct. 10, 2026.
FDA accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX for the adjuvant treatment of certain patients with RCC, based on the Phase 3 LITESPARK-022 trial.
FDA set PDUFA date of June 19, 2026.
FDA accepted supplemental applications for WELIREG plus Lenvima in certain previously treated patients with advanced RCC, based on the Phase 3 LITESPARK-011 trial. Lenvima is being developed as part of a collaboration with Eisai Co., Ltd (Eisai).
FDA set PDUFA date of Oct. 4, 2026.
Announced positive results from Phase 3 KEYNOTE-B15 trial (also known as EV-304) demonstrating KEYTRUDA plus Padcev reduced the risk of event-free survival (EFS) events by 47% and reduced the risk of death by 35% in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC) when given before and after surgery.
KEYNOTE-B15 is the sixth study demonstrating overall survival (OS) with a KEYTRUDA-based regimen in an earlier-stage cancer.
In April, FDA granted priority review for KEYTRUDA and KEYTRUDA QLEX, each with Padcev, for cisplatin-eligible patients with MIBC, based on the Phase 3 KEYNOTE-B15 trial.
FDA set PDUFA date of Aug. 17, 2026.
In a pre-specified interim analysis of the Phase 3 LITESPARK-012 study, compared to KEYTRUDA plus Lenvima, the triplet combination therapy of KEYTRUDA plus Lenvima plus WELIREG, as well as the combination of MK-1308A (an investigational fixed dose coformulation of KEYTRUDA and the anti-CTLA-4 antibody quavonlimab) plus Lenvima, did not show a statistically significant improvement in the primary endpoints of progression-free survival and OS in patients with advanced clear cell RCC.
In the Phase 3 KEYNOTE-975 study, compared to placebo plus definitive chemoradiotherapy (dCRT), KEYTRUDA plus dCRT did not show a statistically significant improvement in the primary endpoint of EFS in certain patients with locally advanced unresectable esophageal carcinoma.
In a prespecified interim analysis of the Phase 3 KEYNOTE-866 study, compared to perioperative placebo plus neoadjuvant chemotherapy, perioperative KEYTRUDA plus neoadjuvant chemotherapy did not show a statistically significant improvement in the primary endpoint of EFS in patients with cisplatin-eligible MIBC who underwent radical cystectomy and pelvic lymph node dissection.
Vaccines and Infectious Diseases:
In April, FDA approved once-daily IDVYNSO, an oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for the treatment of certain adults with virologically suppressed HIV-1, based on Phase 3 MK-8591A-051 and MK-8591A-052 trials. IDVYNSO was also approved in Japan for these patients in March.
Presented data from three Phase 3 trials evaluating DOR/ISL at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI), including:
Results from Phase 3 MK-8591A-053 trial demonstrated that DOR/ISL is the first two-drug regimen that does not include an integrase strand transfer inhibitor to demonstrate non-inferiority and similar safety profile at Week 48 versus bictegravir/emtricitabine/tenofovir alafenamide6 [(50 mg/200 mg/25 mg) (BIC/FTC/TAF)] in adults living with HIV-1 who had not previously received antiretroviral treatment.
Results from the Phase 3 MK-8591A-052 and MK-8591A-051 trials demonstrated that DOR/ISL maintained virologic suppression at Week 96 in adults with virologically suppressed HIV-1 who switched from other antiretroviral therapies, including BIC/FTC/TAF.
In April, EC approved ENFLONSIA for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season, based on Phase 2b/3 CLEVER and Phase 3 SMART trials.
Announced positive second RSV season results from Phase 3 SMART trial evaluating the safety, efficacy and pharmacokinetics of ENFLONSIA in infants and children at increased risk for severe RSV disease over two RSV seasons.
European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinion for an expanded indication for CAPVAXIVE for active immunization against invasive pneumococcal disease and pneumococcal pneumonia in certain children and adolescents at increased risk of pneumococcal disease.
Cardiometabolic and Respiratory:
Presented new data at the American College of Cardiology’s Annual Scientific Session and Expo (ACC.26) including:
Positive results from Phase 3 CORALreef AddOn trial demonstrated significantly greater LDL-C reductions at eight weeks compared to guideline-recommended oral non-statin therapies when added to background statins. This is the third positive Phase 3 study of enlicitide.
Positive data from Phase 2 CADENCE trial provided definitive proof-of-concept for WINREVAIR in adults with the syndrome of combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF). Totality of evidence supports advancing development of WINREVAIR for this distinct patient population into a registrational Phase 3 study.
Animal Health:
FDA approved NUMELVI for dogs, the first and only second-generation Janus kinase (JAK) inhibitor indicated for the control of pruritus associated with allergic dermatitis in dogs 6 months of age and older.
Business Development:
Announced an agreement to acquire Terns Pharmaceuticals, Inc. (Terns) through a subsidiary.
Expands hematology pipeline with the addition of TERN-701, an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor currently in Phase 1/2 development for certain patients with chronic myeloid leukemia (CML).
Transaction expected to close in May.
Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.*
Oncology
KEYTRUDA and KEYTRUDA QLEX, Plus Paclitaxel ± Bevacizumab, FDA Approved for Certain Adults With PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma as Second- or Third-Line Treatment; Based on Results From Phase 3 KEYNOTE-B96 Trial
EC Approved KEYTRUDA Plus Paclitaxel ± Bevacizumab for Treatment of Adults With PD-L1 (CPS ≥1) Platinum-Resistant Recurrent Ovarian Carcinoma Who Have Received One or Two Prior Systemic Treatment Regimens; Based on Results From Phase 3 KEYNOTE-B96 Trial
I-DXd Granted Priority Review in U.S. for Adult Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer Who Experienced Disease Progression on or After Platinum-Based Chemotherapy; Based on Results From Phase 2 Ideate-Lung01 Trial; FDA Set PDUFA Date of Oct. 10, 2026
FDA Granted Priority Review for KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, for Cisplatin-Eligible Patients With MIBC; Based on Results From Phase 3 KEYNOTE-B15 Trial; FDA Set PDUFA Date of Aug. 17, 2026
KEYTRUDA Plus Padcev Reduced Risk of EFS Events by 47% and Risk of Death by 35% for Cisplatin-Eligible Patients With MIBC When Given Before and After Surgery; Results From Phase 3 KEYNOTE-B15 Trial
KEYTRUDA Plus Paclitaxel With or Without Bevacizumab Significantly Improved Key Secondary Endpoint of OS Versus Paclitaxel With or Without Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer; Results From Phase 3 KEYNOTE-B96 Trial
KEYTRUDA Plus WELIREG Given as Adjuvant Therapy Reduced Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain Patients With Earlier-Stage RCC; Results From Phase 3 LITESPARK-022 Trial; FDA Set PDUFA Date of June 19, 2026 for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX
WELIREG Plus Lenvima Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With RCC; Results From Phase 3 LITESPARK-011 Trial; FDA Set PDUFA Date of Oct. 4, 2026
The Company and Eisai Provided Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced RCC
Vaccines and
Infectious Diseases
FDA Approved the Company’s Once-Daily IDVYNSO for Adults With Virologically Suppressed HIV-1; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052 Trials
The Company Announced Late-Breaking Data From Three Phase 3 Trials Evaluating DOR/ISL, an Investigational, Once-Daily, Two-Drug Regimen for the Treatment of Adults Living With HIV-1, at CROI 2026
EC Approved ENFLONSIA for the Prevention of RSV Lower Respiratory Tract Disease in Infants During Their First RSV Season; Based on Results From Phase 2b/3 CLEVER and Phase 3 SMART Trials
The Company Announced Positive New Data for ENFLONSIA for Infants and Children Under 2 Years of Age at Increased Risk for Severe RSV Disease Over Two RSV Seasons; Results From Phase 3 SMART Trial
The Company Presented New Data Reinforcing Long-Term Efficacy of GARDASIL 9 and GARDASIL at the EUROGIN International Multidisciplinary HPV Congress 2026
Cardiometabolic and
Respiratory
Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Demonstrated Significantly Greater LDL-C Reductions at Eight Weeks Compared to Guideline-Recommended Oral Non-Statin Therapies When Added to Background Statins; Results From Phase 3 CORALreef AddOn Trial
Positive Data From Phase 2 CADENCE Trial Provided Definitive Proof-of-Concept for WINREVAIR in Adults With the Syndrome of CpcPH-HFpEF
Ophthalmology
The Company Initiated Pivotal Phase 2b/3 Trial Evaluating MK-8748, an Investigational Bispecific Tie2 Agonist/VEGF Inhibitor, for the Treatment of Neovascular Age-Related Macular Degeneration
Animal Health
FDA Approved NUMELVI for Dogs – First and Only Second-Generation JAK Inhibitor for the Control of Pruritus Associated With Allergic Dermatitis
Research
The Company and Mayo Clinic Announced New Research and Development Collaboration to Support AI-Enabled Drug Discovery and Precision Medicine
The Company and Google Cloud Partnered To Accelerate Agentic AI Enterprise Transformation
*References to the Company’s name in the above news release titles have been modified for the purpose of this announcement.
Upcoming Investor Event
The Company will hold an Oncology Investor Event to coincide with the 2026 American Society of Clinical Oncology Annual Meeting on Monday, June 1, 2026, 6 p.m. CT, during which senior management will provide an update on the Company’s oncology strategy and program. The event will take place in Chicago and will be accessible via live audio webcast at this weblink.
Full-Year 2026 Financial Outlook
The following table summarizes the Company’s full-year financial outlook.
Full Year 2026
Updated
Prior
Sales*
$65.8 billion to $67.0 billion
$65.5 billion to $67.0 billion
Non-GAAP Gross margin3
Approximately 82%
Approximately 82%
Non-GAAP Operating expenses3**
$36.0 billion to $36.8 billion
$35.9 billion to $36.9 billion
Non-GAAP Other (income) expense, net3
Approximately $1.3 billion expense
Approximately $1.3 billion expense
Non-GAAP Effective income tax rate3
23.5% to 24.5%
23.5% to 24.5%
Non-GAAP EPS3***
$5.04 to $5.16
$5.00 to $5.15
Share count (assuming dilution)
Approximately 2.48 billion
Approximately 2.48 billion
*The Company does not have any non-GAAP adjustments to sales.
**Includes a one-time charge of $9.0 billion for the acquisition of Cidara. Outlook does not reflect the proposed acquisition of Terns or assume any additional significant potential business development transactions.
***Includes a one-time charge of $3.62 per share for the acquisition of Cidara.
The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective income tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results.
The Company now anticipates full-year 2026 sales to be between $65.8 billion and $67.0 billion, including a positive impact from foreign exchange of approximately 1% at mid-April 2026 exchange rates.
The Company continues to expect the full-year non-GAAP effective income tax rate to be between 23.5% and 24.5% including the impact of the non-tax-deductible one-time charge for the acquisition of Cidara.
The Company now expects full-year 2026 non-GAAP EPS to be between $5.04 and $5.16, including a positive impact from foreign exchange of approximately $0.10 per share at mid-April 2026 exchange rates. This range includes a one-time charge of $9.0 billion, or $3.62 per share, related to the acquisition of Cidara. In 2025, non-GAAP EPS of $8.98 was negatively impacted by one-time charges of $0.20 per share in the aggregate related to certain business development transactions.
In April 2026, the Company announced a tender offer to acquire Terns. The Company’s financial outlook does not reflect this transaction, which is expected to be accounted for as an asset acquisition and result in a one-time charge of approximately $5.8 billion, or approximately $2.35 per share. In addition, taking into consideration operational investment to advance TERN-701, as well as the cost of financing the transaction, the Company also anticipates EPS will be negatively impacted by approximately $0.12 over the remainder of 2026 following the close, which is expected in May.
The financial outlook does not assume additional significant potential business development transactions.
Earnings Conference Call
Investors, journalists and the general public may access a live audio webcast of the call on Thursday, April 30, at 9 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website.
All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590.
About Our Company
At Merck & Co., Inc., Rahway, N.J., USA, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “Company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the Company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Appendix
Generic product names are provided below.
Pharmaceutical
BRIDION (sugammadex)
CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine)
ENFLONSIA (clesrovimab-cfor)
GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant)
GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
IDVYNSO (doravirine/islatravir)
JANUMET (sitagliptin and metformin HCl)
JANUVIA (sitagliptin)
KEYTRUDA (pembrolizumab)
KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph)
LAGEVRIO (molnupiravir)
Lenvima (lenvatinib)
Lynparza (olaparib)
M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)
OHTUVAYRE (ensifentrine)
PREVYMIS (letermovir)
PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)
VARIVAX (Varicella Virus Vaccine Live)
ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent)
WELIREG (belzutifan)
WINREVAIR (sotatercept-csrk)
Animal Health
BRAVECTO (fluralaner)
NUMELVI (atinvicitinib tablets)
________________________________
1 Available in some markets as KEYTRUDA SC.
2 Net (loss) income attributable to the Company.
3 The Company is providing certain 2026 and 2025 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the Company’s results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release.
4 Reflects expenses related to business combinations, including the amortization of intangible assets, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations, licensing arrangements and asset acquisitions, and recognition of fair value step-up to inventories for asset acquisitions.
5 Includes the estimated income tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments for all periods presented.
6 Bictegravir/emtricitabine/tenofovir alafenamide (BIKTARVY) is a registered trademark of Gilead Sciences, Inc.
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1
GAAP
% Change
1Q26
1Q25
Sales
$
16,286
$
15,529
5%
Costs, Expenses and Other
Cost of sales
4,195
3,419
23%
Selling, general and administrative
2,700
2,552
6%
Research and development
12,592
3,621
*
Restructuring costs
195
69
*
Other (income) expense, net
138
(35
)
*
(Loss) Income Before Taxes
(3,534
)
5,903
*
Income Tax Provision
709
818
Net (Loss) Income
(4,243
)
5,085
*
Less: Net (Loss) Income Attributable to Noncontrolling Interests
(3
)
6
Net (Loss) Income Attributable to Merck & Co., Inc., Rahway, N.J., USA
$
(4,240
)
$
5,079
*
(Loss) Earnings per Common Share Assuming Dilution (1)
$
(1.72
)
$
2.01
*
Average Shares Outstanding Assuming Dilution (1)
2,472
2,531
Tax Rate
-20.1
%
13.9
%
* 100% or greater
(1) Because the Company recorded a net loss in the first quarter of 2026, no potential dilutive common shares were used in the computation of loss per common share assuming dilution as the effect would have been anti-dilutive.
MERCK & CO., INC., RAHWAY, N.J., USA
FIRST QUARTER 2026 GAAP TO NON-GAAP RECONCILIATION
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2a
GAAP
Acquisition- and
Divestiture-Related
Costs (1)
Restructuring
Costs (2)
(Income) Loss
from Investments
in Equity Securities
Adjustment
Subtotal
Non-GAAP
First Quarter
Cost of sales
$
4,195
1,014
237
1,251
$
2,944
Selling, general and administrative
2,700
32
32
2,668
Research and development
12,592
34
34
12,558
Restructuring costs
195
195
195
–
Other (income) expense, net
138
(180
)
(180
)
318
Loss Before Taxes
(3,534
)
(1,046
)
(466
)
180
(1,332
)
(2,202
)
Income Tax Provision (Benefit)
709
(202
)
(3)
(85
)
(3)
39
(3)
(248
)
957
Net Loss
(4,243
)
(844
)
(381
)
141
(1,084
)
(3,159
)
Net Loss Attributable to Merck & Co., Inc., Rahway, N.J., USA
(4,240
)
(844
)
(381
)
141
(1,084
)
(3,156
)
Loss per Common Share Assuming Dilution (4)
$
(1.72
)
(0.34
)
(0.16
)
0.06
(0.44
)
$
(1.28
)
Tax Rate
-20.1
%
-43.5
%
Only the line items that are affected by non-GAAP adjustments are shown.
The Company is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing non-GAAP information enhances investors’ understanding of the Company’s results because management uses non-GAAP measures to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. The non-GAAP information presented should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP.
(1) Amounts included in cost of sales reflect expenses for the amortization of intangible assets, as well as the recognition of fair value step-up of inventories related to the 2025 Verona Pharma plc acquisition. Amounts included in selling, general and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures.
(2) Amounts primarily include employee separation costs, accelerated depreciation and asset impairment charges associated with facilities to be closed or divested, as well as contractual termination costs, associated with activities under the Company's formal restructuring programs.
(3) Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.
(4) Because the Company recorded a net loss in the first quarter of 2026, no potential dilutive common shares were used in the computation of loss per common share assuming dilution as the effect would have been anti-dilutive.
MERCK & CO., INC., RAHWAY, N.J., USA
FRANCHISE / KEY PRODUCT SALES
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3
2026
2025
1Q
1Q
1Q
2Q
3Q
4Q
Full Year
Nom %
Ex-Exch %
TOTAL SALES (1)
$16,286
$15,529
$15,806
$17,276
$16,400
$65,011
5
3
PHARMACEUTICAL
14,349
13,638
14,050
15,611
14,843
58,142
5
2
Oncology
Keytruda
7,906
7,205
7,956
8,142
8,337
31,641
10
6
Keytruda Qlex
128
5
35
40
-
-
Alliance Revenue – Lynparza (2)
341
312
370
379
389
1,450
9
6
Alliance Revenue – Lenvima (2)
256
258
265
258
272
1,053
-1
-2
Welireg
199
137
162
196
220
716
45
43
Alliance Revenue – Reblozyl (3)
148
119
107
136
164
525
25
25
Vaccines (4)
Gardasil/Gardasil 9
1,069
1,327
1,126
1,749
1,031
5,233
-19
-22
ProQuad/M-M-R II/Varivax
538
539
609
684
619
2,451
-
-2
RotaTeq
206
228
121
204
119
673
-10
-11
Vaxneuvance
202
230
229
226
140
825
-12
-16
Capvaxive
142
107
129
244
279
759
33
31
Enflonsia
1
79
21
100
-
-
Cardiometabolic & Respiratory
Winrevair
525
280
336
360
467
1,443
88
87
Ohtuvayre
131
178
178
-
-
Alliance Revenue - Adempas/Verquvo (5)
109
106
123
112
129
470
3
3
Adempas (6)
78
68
80
82
83
312
15
5
Infectious Diseases
Bridion
472
441
461
439
499
1,841
7
7
Prevymis
272
208
228
266
275
978
31
26
Zerbaxa
82
70
74
81
87
312
17
14
Delstrigo
75
67
83
77
79
306
12
1
Isentress/Isentress HD
59
90
86
82
67
325
-34
-36
Dificid
34
83
96
43
25
247
-59
-59
Lagevrio
28
102
83
138
57
380
-73
-73
Diabetes
Januvia
367
549
372
382
302
1,604
-33
-33
Janumet
207
247
251
243
199
940
-16
-18
Other Pharmaceutical (7)
774
865
703
1,004
770
3,340
-11
-12
ANIMAL HEALTH
1,791
1,588
1,646
1,615
1,505
6,354
13
6
Livestock
1,064
924
961
1,023
987
3,896
15
8
Companion Animal
727
664
685
592
518
2,458
9
4
Other Revenues (8)
146
303
110
50
52
515
-52
4
Sum of quarterly amounts may not equal year-to-date amounts due to rounding.
(1) Only select products are shown.
(2) Alliance Revenue represents the Company's share of profits, which are product sales net of cost of sales and commercialization costs.
(3) Alliance Revenue represents royalties.
(4) Total Vaccines sales were $2,314 million and $2,607 million in the first quarter of 2026 and 2025, respectively.
(5) Alliance Revenue represents the Company's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs.
(6) Net product sales in the Company's marketing territories.
(7) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $161 million and $44 million in the first quarter of 2026 and 2025, respectively.
(8) Other Revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Other Revenues related to the receipt of milestone payments for out-licensed products were $132 million and $95 million in the first quarter of 2026 and 2025, respectively.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260430995314/en/
Media Contacts:
Michael Levey
michael.levey@msd.com
John Cummins
john.cummins2@msd.com
Investor Contacts:
Peter Dannenbaum
(732) 594-1579
Steven Graziano
(732) 594-1583
Original: Merck & Co., Inc., Rahway, N.J., USA Announces First-Quarter 2026 Financial Results; Highlights Significant Regulatory Approvals and Clinical Milestones
US Market News
2月前
Merck’s Playing with Heart Program Teams Up With Professional Baseball Clubs and Baseball Legends to Help Raise Awareness About LDL-C, Called “Bad” Cholesterol, and How It May Impact the Risk of Heart Attack or StrokeApril 28, 2026 6:45 AM
Business Wire
The Yankees, Red Sox, Phillies, Braves, Astros, Cardinals, Giants, Padres, and Angels are joining Merck to help educate fans about high bad cholesterol and how it may increase the risk of heart attack or stroke
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced a collaboration with nine professional baseball teams and former professional baseball players to launch the Playing with Heart educational program to help educate adults about the importance of knowing their low-density lipoprotein cholesterol (LDL-C), called “bad” cholesterol, number and the potential increased risk of heart attack or stroke.
Playing with Heart connects Merck’s commitment to cardiovascular health with baseball, America’s favorite pastime, to raise awareness and encourage adults to talk with their doctor about how lowering bad cholesterol could help lower their risk of heart attack or stroke. Visit playingwithheart.com to learn more.
Every year it is estimated that more than 800,000 people in the U.S. have a heart attack. Plaque buildup in the arteries is a major cause of heart attacks. Over time bad cholesterol can combine with fats and other substances in the blood to create plaque. Plaque buildup can lead to blockages, ruptures, and blood clots, which may increase your risk of heart attack or stroke.
“Merck is proud to join with some of the biggest franchises in baseball and with WomenHeart for this first-of-its-kind collaboration,” said Cris Regent, associate vice president, U.S. Pharma Cardiovascular and Metabolic, Merck. “Cardiovascular disease is the leading cause of death in the U.S., and through Playing with Heart, we hope to increase conversations between adults and their doctors about high bad cholesterol and the risk of heart attack or stroke.”
During the 2026 baseball season, the Playing with Heart program will feature a lineup of baseball legends, clubs, and ambassadors who will share their personal stories about high bad cholesterol. Merck, along with WomenHeart patient education network, and nine professional baseball teams, will also host in-stadium events to provide education about bad cholesterol and to help encourage adults to learn more about the increased risk of heart attack or stroke. Baseball legends, clubs, and ambassadors participating in Playing with Heart include:
Albert Pujols, Playing with Heart National Ambassador
The New York Yankees, and Aaron Boone, CC Sabathia
The Boston Red Sox, and Lou Merloni
The Philadelphia Phillies, and Charlie Manuel
The Atlanta Braves, and Javy Lopez
The Houston Astros, and Geoff Blum
The St. Louis Cardinals, and Sierra Kile (daughter of the late Darryl Kile)
The San Francisco Giants, and Dusty Baker
The San Diego Padres, and Mark Loretta, Jake Peavy
The Los Angeles Angels, and Bobby Valentine, Clyde Wright
“The Playing with Heart program has the potential to increase understanding of bad cholesterol and its importance to heart health,” said Celina Gorre, chief executive officer, WomenHeart. “Education is at the heart of everything we do, and the Playing with Heart program gives us an opportunity to use the visibility of baseball to help raise awareness about bad cholesterol and the risk of heart attack or stroke.”
WomenHeart, which has a network of more than 1,000 patient champions, will help bring the Playing with Heart educational program to local communities.
About atherosclerotic cardiovascular disease and risk of heart attack and stroke
Atherosclerotic cardiovascular disease (ASCVD) is a condition caused by the buildup of plaque (bad cholesterol, fats, and other substances) within the arteries, leading to narrowed or blocked blood vessels that can result in serious cardiovascular events. ASCVD includes conditions such as coronary artery disease, peripheral artery disease, and cerebrovascular disease. It is a leading cause of death in the United States, accounting for approximately 25% of all deaths in the U.S. ASCVD continues to pose a significant public health burden, underscoring the need for awareness and education.
About WomenHeart
WomenHeart is the nation’s only patient-centered organization dedicated to servicing adults living with or at risk for heart disease. WomenHeart is active in more than 30 states, in cities such as Kansas City, New York City, Phoenix, and Washington, D.C. WomenHeart focuses on raising awareness, engaging local leaders, and empowering women. The organization is dedicated to prompting awareness, advocacy, and supporting women with heart disease, empowering them to take charge of their own heart health.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
View source version on businesswire.com: https://www.businesswire.com/news/home/20260428069964/en/
Media Contacts:
Julie Cunningham
(617) 519-6264
julie.cunningham@merck.com
Marc Boston
(215) 429-7034
marc_boston@merck.com
Original: Merck’s Playing with Heart Program Teams Up With Professional Baseball Clubs and Baseball Legends to Help Raise Awareness About LDL-C, Called “Bad” Cholesterol, and How It May Impact the Risk of Heart Attack or Stroke
US Market News
2月前
Merck Announces Expiration of Hart-Scott-Rodino Act Waiting Period to Acquire Terns Pharmaceuticals, Inc.April 24, 2026 6:45 AM
Business Wire
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (“HSR”), in connection with Merck’s pending acquisition of Terns Pharmaceuticals, Inc. (“Terns”) (Nasdaq: TERN) expired at 11:59 p.m., Eastern Time, on April 23, 2026.
As previously announced on April 7, 2026, Merck commenced, through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Terns, for $53.00 net in cash for each share of Terns common stock validly tendered and not validly withdrawn in the offer, without interest and less any applicable tax withholding. The expiration of the HSR waiting period satisfies one of the conditions necessary for the consummation of the tender offer. Consummation of the tender offer remains subject to other conditions described in the tender offer statement on Schedule TO filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 7, 2026, including the tender of shares representing more than 50% of the total number of Terns’ outstanding shares.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Important Information About the Tender Offer
This release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Terns or any other securities, nor is it a substitute for the tender offer materials described herein. A tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, has been filed by Merck, Merck Sharp & Dohme LLC and Thailand Merger Sub, Inc. with the SEC, and a solicitation/recommendation statement on Schedule 14D-9 has been filed by Terns with the SEC.
INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES, INCLUDING THE TERMS AND CONDITIONS OF THE OFFER.
Investors and security holders may obtain a free copy of the Offer to Purchase, the related Letter of Transmittal, other tender offer documents and the Solicitation/Recommendation Statement and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the tender offer named in the tender offer statement. In addition, Merck and Terns file annual, quarterly and current reports and other information with the SEC, which are available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by Merck may be obtained at no charge on Merck’s internet website at www.merck.com or by contacting Merck at 126 East Lincoln Avenue P.O. Box 2000, Rahway, NJ 07065 USA, or by phone at (908) 740-4000. Copies of the documents filed with the SEC by Terns may be obtained at no charge from Terns’ internet website at www.ternspharma.com or by contacting Terns at 1065 East Hillsdale Blvd., Suite 100, Foster City, CA 94404 or (650)-525-5535 Ext.101.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expects,” “intends,” “believes,” “may,” “plan” or “will.” Forward-looking statements in this release include, but are not limited to, statements related to the ability of the company and Terns to complete the transactions contemplated by the transaction agreement, including the parties’ ability to satisfy the conditions to the consummation of the transaction contemplated thereby, statements about the expected timetable for completing the transaction, the company’s and Terns’ beliefs and expectations and statements about the benefits sought to be achieved in the company’s proposed acquisition of Terns, the potential effects of the acquisition on both the company and Terns, and the possibility of any termination of the transaction agreement.
Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Terns’ clinical studies and other risks related to clinical development, delays in or unanticipated action by regulatory authorities, risks related to government contracts, having to use cash in ways other than as expected and other risks, uncertainties associated with Terns’ business in general; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the proposed transaction contained in the transaction agreement may not be satisfied or waived (including, but not limited to, the failure to obtain a sufficient number of tendered shares from Terns’ stockholders); the effects of disruption from the transactions contemplated by the transaction agreement and the impact of the announcement and pendency of the transactions on Terns’ business; the risk that stockholder litigation in connection with the transaction may result in significant costs of defense, indemnification and liability; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the SEC available at the SEC’s Internet site (www.sec.gov).
View source version on businesswire.com: https://www.businesswire.com/news/home/20260424846212/en/
Media Contacts:
Carly Myar
carly.myar@merck.com
John Cummins
john.cummins2@merck.com
Investor Contacts:
Peter Dannenbaum
(732) 594-1579
Steven Graziano
(732) 594-1583
Original: Merck Announces Expiration of Hart-Scott-Rodino Act Waiting Period to Acquire Terns Pharmaceuticals, Inc.
US Market News
2月前
Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC)April 21, 2026 6:45 AM
Business Wire
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced results from the Phase 3 LITESPARK-012 trial evaluating combination regimens for the first-line treatment of patients with advanced clear cell renal cell carcinoma (RCC). The trial evaluated the triplet therapy of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus WELIREG® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor. The study also evaluated MK-1308A, the coformulation of KEYTRUDA and quavonlimab, Merck’s investigational anti-CTLA-4 antibody, plus LENVIMA. Both combination regimens were compared to KEYTRUDA plus LENVIMA for these patients.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260421205834/en/
At a pre-specified interim analysis, the combination regimens did not meet the dual primary endpoints of progression-free survival (PFS) and overall survival (OS) for the first-line treatment of patients with RCC compared to KEYTRUDA plus LENVIMA. The safety profiles of the combination regimens were consistent with those observed in previously reported studies evaluating the individual medicines and the KEYTRUDA plus LENVIMA combination. A full evaluation of the data from this study is ongoing, and Merck and Eisai will work with investigators to share the results with the scientific community.
“With the LITESPARK-012 trial, we explored whether combining therapies with established activity could improve upon well-established standards set by KEYTRUDA-based regimens, reflecting our commitment to continuously explore ways to improve outcomes for the kidney cancer community,” said Dr. M. Catherine Pietanza, Vice President, Global Clinical Development, Merck Research Laboratories. “While these regimens did not demonstrate the results we hoped, the data deepen our understanding of advanced renal cell carcinoma and will help shape the next generation of treatment approaches.”
“While we are disappointed that LITESPARK-012 did not meet its primary endpoints, the findings reinforce the central role of KEYTRUDA plus LENVIMA in the first-line treatment of patients with advanced renal cell carcinoma,” said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc. “Findings from trials such as this play an important role in shaping health care providers’ perspectives as the treatment paradigm for advanced renal cell carcinoma continues to evolve. We are committed to advancing the care of people living with this disease and we are grateful to the patients, caregivers and investigators whose participation and dedication made this research possible.”
Results from the LITESPARK-012 trial do not affect other ongoing trials from the LITESPARK clinical program, including those conducted jointly with Eisai. As previously announced, the U.S. Food and Drug Administration (FDA) has accepted two supplemental New Drug Applications (sNDA) for review based on the Phase 3 LITESPARK-011 trial evaluating WELIREG in combination with LENVIMA for certain previously treated patients with advanced RCC and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 4, 2026.
KEYTRUDA is currently approved as adjuvant monotherapy and in combination regimens for appropriate patients with RCC in the U.S., European Union (EU), Japan and other countries around the world. For more information, please see the “Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.” section below.
KEYTRUDA plus LENVIMA is approved in the U.S., EU, Japan and other countries for the first-line treatment of adult patients with advanced RCC. Lenvatinib is approved as KISPLYX for advanced RCC in the EU.
LENVIMA in combination with everolimus is approved in the U.S., EU and other regions for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy.
WELIREG is approved in the U.S., EU, Japan and other countries for the treatment of adult patients with advanced clear cell RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.
About LITESPARK-012
LITESPARK-012 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT04736706) evaluating either the triplet therapy of KEYTRUDA plus LENVIMA plus WELIREG or MK-1308A plus LENVIMA compared to KEYTRUDA plus LENVIMA for the first-line treatment of patients with advanced clear cell RCC. The primary endpoints are PFS, as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and OS. Secondary endpoints are objective response rate and duration of response as assessed by BICR according to RECIST v1.1, as well as safety. The study enrolled 1,688 patients who were randomized to receive:
KEYTRUDA (400 mg intravenously [IV] every six weeks [Q6W]) plus LENVIMA (20 mg orally once daily [QD]) plus WELIREG (120 mg orally QD);
MK-1308A (coformulation of pembrolizumab [400 mg] and quavonlimab [25 mg] IV Q6W) plus LENVIMA (20 mg orally QD);
KEYTRUDA (400 mg IV Q6W) plus LENVIMA (20 mg orally QD).
All study drugs were continued until protocol-specified discontinuation criteria. KEYTRUDA and MK-1308A were administered for up to two years (approximately 18 cycles). WELIREG and LENVIMA may have been administered in combination or as a single agent until progressive disease or discontinuation.
About renal cell carcinoma
Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer diagnosed and approximately 156,000 deaths from the disease worldwide. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases, and about 70% are a form called clear cell RCC, which tends to be more aggressive and faster spreading. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage.
About Merck’s research in genitourinary cancers
Merck is advancing research aimed at helping transform the treatment landscape and broaden options for people with genitourinary (GU) cancers, including bladder, kidney and prostate cancers. Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equaling over 1 in 8 of all cancer incidences. Through a robust clinical development program with more than 50 ongoing clinical trials evaluating more than 22,000 patients around the world, Merck is investigating the potential of several portfolio medicines and pipeline assets, leveraging multiple novel combination strategies, across various stages of disease, to help address unmet needs in GU cancers.
About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.
KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information.
Selected Important Safety Information for KEYTRUDA
Severe and Fatal Immune-Mediated Adverse Reactions
KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.
Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.
Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.
Immune-Mediated Colitis
KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (
US Market News
2月前
FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), for Cisplatin-Eligible Patients with Muscle-Invasive Bladder CancerApril 20, 2026 6:48 AM
Business Wire
Applications are supported by the Phase 3 KEYNOTE-B15 results, which showed that KEYTRUDA plus Padcev demonstrated a statistically significant and clinically meaningful improvement in event-free survival and overall survival in study participants
If approved, these regimens would be the first and only perioperative treatments for patients with MIBC regardless of cisplatin eligibility, marking potential new standards of care
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapy, each in combination with Padcev® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of August 17, 2026.
If approved, these indications would expand the use of KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, as the first perioperative treatments for patients with MIBC regardless of cisplatin eligibility and build on the previously approved indications of the combination for the treatment of patients with MIBC who are ineligible for cisplatin-based chemotherapy.
“Results from KEYNOTE-B15 challenge long-held expectations for patients with muscle-invasive bladder cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “Even with curative-intent surgery and chemotherapy, patients still experience disease progression or limited survival. These data add to the growing body of evidence demonstrating that KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, have the potential to reshape how we approach treatment for these patients and improve outcomes for people facing this aggressive disease.”
The sBLAs are based on data from the Phase 3 KEYNOTE-B15 trial (also known as EV-304), which was conducted in collaboration with Pfizer and Astellas, which were presented at the recent American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium. The companies plan to share these results with regulatory authorities worldwide for potential regulatory filings.
KEYTRUDA plus Padcev is currently approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the U.S., the European Union (EU), Japan and several other countries around the world. KEYTRUDA plus Padcev is also approved in the U.S. for the treatment of adult patients with MIBC who are ineligible for cisplatin-based chemotherapy. KEYTRUDA as a monotherapy is also approved in the U.S., EU, Japan and other countries for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC).
KEYTRUDA plus Padcev has now demonstrated an overall survival (OS) benefit across three Phase 3 trials in bladder cancer. In addition to KEYNOTE-B15, these trials include previously announced positive results from KEYNOTE-905 for the treatment of patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy and positive results from KEYNOTE-A39 for the treatment of adult patients with la/mUC. Three additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic disease. Two of these studies are in MIBC including KEYNOTE-866 (NCT03924856) and KEYNOTE-992 (NCT04241185). KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in KEYNOTE-676 (NCT03711032).
KEYNOTE-B15 is one of six Phase 3 studies of a KEYTRUDA-based regimen in an earlier stage of cancer to demonstrate an OS benefit. It was also the 15th positive pivotal trial for a KEYTRUDA-based regimen in earlier-stage cancers.
About KEYNOTE-B15/EV-304
KEYNOTE-B15, also known as EV-304, is an open-label, randomized Phase 3 trial (ClinicalTrials.gov, NCT04700124) evaluating perioperative KEYTRUDA in combination with Padcev and surgery (radical cystectomy and pelvic lymph node dissection) versus neoadjuvant chemotherapy (gemcitabine plus cisplatin) and surgery in patients with MIBC who are cisplatin-eligible. The trial enrolled 808 patients who were randomized to receive either:
Four cycles (each cycle length is 21 days) of neoadjuvant KEYTRUDA intravenous (IV) infusion plus enfortumab vedotin IV infusion, followed by surgery, followed by 13 cycles of adjuvant KEYTRUDA IV infusion plus five cycles of enfortumab vedotin IV infusion, or;
Four cycles (each cycle is 21 days) of standard of care neoadjuvant chemotherapy followed by surgery.
The primary endpoint is event-free survival (EFS), defined as the time from randomization to the first occurrence of the following events: radiographic disease progression precluding radical cystectomy and pelvic lymph node dissection, failure to undergo surgery in participants with residual disease, gross residual disease left behind at time of surgery, local or distant recurrence based on blinded independent central review or death due to any cause. The key secondary endpoints are OS and pathologic complete response rate.
About bladder cancer
In 2022, bladder cancer changed the lives of more than 600,000 people around the world. According to some clinical practice guidelines, about 25% of newly diagnosed bladder cancer cases are MIBC. The standard of care for patients with MIBC has been neoadjuvant cisplatin-based chemotherapy followed by surgery, which is shown to prolong survival. However, nearly half of patients who undergo this standard treatment experience recurrence.
About Merck’s research in genitourinary cancers
Merck is advancing research aimed at helping transform the treatment landscape and broaden options for people with genitourinary (GU) cancers, including bladder, kidney and prostate cancers. Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equaling over 1 in 8 of all cancer incidences. Through a robust clinical development program with more than 50 ongoing clinical trials evaluating more than 22,000 patients around the world, Merck is investigating the potential of several portfolio medicines and pipeline assets, leveraging multiple novel combination strategies, across various stages of disease, to help address unmet needs in GU cancers.
About Merck’s early-stage cancer clinical program
Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is evaluating our portfolio of medicines and pipeline candidates in earlier disease states, with more than 30 ongoing registrational studies across multiple types of cancer.
About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
About KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use, 165mg + 2,000 units/mL
KEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL).
Selected KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Indications in the U.S.
Urothelial Cancer
KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma:
who are not eligible for any platinum-containing chemotherapy, or
who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the treatment of adult patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
See additional selected KEYTRUDA and KEYTRUDA QLEX indications in the U.S. after the Selected Important Safety Information.
Selected Important Safety Information for KEYTRUDA and KEYTRUDA QLEX
Contraindications
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients.
Severe and Fatal Immune-Mediated Adverse Reactions
KEYTRUDA and KEYTRUDA QLEX are monoclonal antibodies that belong to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA or KEYTRUDA QLEX in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue KEYTRUDA and KEYTRUDA QLEX depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA and KEYTRUDA QLEX require interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Immune-mediated pneumonitis occurred in 5% (13/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including fatal (0.4%), Grade 3 (2%), and Grade 2 (1.2%) adverse reactions.
Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.
Immune-Mediated Colitis
KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (
US Market News
2月前
New Survey Shows HPV Awareness Isn't Keeping Pace with Certain HPV-Related Cancer Trends in CanadaApril 15, 2026 7:00 AM
PR Newswire (Canada)
KIRKLAND, QC, April 15, 2026 /CNW/ -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, has released new data examining Canadians' knowledge of human papillomavirus (HPV) across age, gender, and regional groups. The survey revealed notable gaps in awareness—particularly among men and younger adults—even as rates of certain HPV-related cancers continue to rise across the country.
Key Survey Findings: Among younger adult respondents aged 18-24, fewer than half (49%) recognized HPV as a sexually transmitted infection, and about one-third (34%) of the same group reported not knowing what HPV is.Nearly one-third of men (31%) reported not knowing what HPV is, and close to half of all men (45%) were not aware of any potential consequences of a persistent HPV infection.
Awareness that the rate of certain HPV-related head and neck cancers, such as throat cancer, are increasing among men, was limited across age groups, with 53% of all respondents (both men and women) unaware of this trend.Men were less likely than women to believe they played a role in helping reduce their risk of contracting or spreading an HPV infection (57% vs. 74%).For more insights, refer to the HPV Awareness Factsheet.Understanding the Growing Burden of Certain HPV-Related Cancers
While HPV is most often associated with cervical cancer, throat (oropharyngeal) cancer is now the most common HPV-related cancer in Canada, affecting more men than women. Despite this shift, men appeared more likely to believe that HPV is not a concern to them (16% vs 12%) and were more likely to report not knowing which types of cancers and diseases the infection can cause compared to the overall surveyed population (45% vs. 37%). These knowledge gaps may contribute to lower engagement and reduced health-seeking behaviours.The survey also explored how Canadians approached conversations about HPV and the barriers that may hold them back. Nearly three-quarters (71%) of adult respondents identified at least one obstacle to speaking with a healthcare professional, including lack of awareness or information and feelings of embarrassment. These factors may make it more difficult to ask questions or clarify misconceptions."The survey's findings reinforce the importance of HPV disease awareness," said Matthew Thornhill, Executive Director, Vaccines Business Unit at Merck Canada. "We're seeing trends showing that men are less informed about HPV than their female counterparts, along with other findings suggesting they may feel less concerned or inclined to seek information about HPV. Strengthening awareness, particularly among low-awareness groups, is an important step toward encouraging more informed action against HPV."Overall, the findings highlight opportunities to strengthen public health education in Canada. Clear, accessible information could help Canadians break the stigma around HPV and close persistent knowledge gaps.While Head & Neck Cancer Awareness Month offers an important opportunity to elevate these conversations, HPV-related risks extend far beyond a single cancer type, or a single month. Sustained, year-round education is essential to ensure Canadians understand the broader health implications of HPV and feel empowered to have informed discussions with a healthcare provider.To learn more, visit knowhpv.ca and speak to a healthcare provider.About the Survey
This online survey was conducted by Ipsos on behalf of Merck Canada to assess awareness, perceptions, and understanding of human papillomavirus (HPV) among Canadian adults. The survey was fielded March 6 to March 11, 2026. A total of n=1000 Canadians aged 18 to 47 participated in the survey which was conducted via the Ipsos' panel. Quotas and weighting were used to ensure the sample's composition reflects that of the Canadian population according to census parameters. This survey has a credibility interval of +/- 3.8 per cent 19 times out of 20, of what the results would have been had all Canadians aged 18+ been surveyed. The credibility interval will be wider among subsets of the population.About Human Papillomavirus (HPV)
Human papillomavirus (HPV) is a common sexually transmitted infection that can spread through intimate skin-to-skin contact in the genital area or during vaginal, anal, or oral sex. About 75% of sexually active people will contract at least one HPV infection in their lifetime, often without symptoms. While most infections clear on their own, persistent infection with high-risk strains could lead to certain types of cancer. HPV is responsible for approximately 100% of cervical cancers, 90% of anal cancers, 60% to 73% of throat (oropharyngeal) cancers, 40% of vaginal and vulvar cancers, and 40% to 50% of penile cancers.About Merck
At Merck, known as MSD, outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information about our operations in Canada, visit www.merck.ca and connect with us on LinkedIn @MerckCanada.Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2025 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).© 2026 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved.Media Requests:
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mediacanada@merck.comSOURCE Merck
Original: New Survey Shows HPV Awareness Isn't Keeping Pace with Certain HPV-Related Cancer Trends in Canada
US Market News
3月前
Ifinatamab Deruxtecan Granted Priority Review in the U.S. for Adult Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer who Experienced Disease Progression on or After Platinum-Based ChemotherapyApril 13, 2026 7:00 AM
Business Wire
Based on results from IDeate-Lung01 phase 2 trial, with support from IDeate-PanTumor01 phase 1/2 trial
If approved, ifinatamab deruxtecan would be a first-in-class B7-H3 directed DXd antibody drug conjugate for these patients
Daiichi Sankyo (TSE: 4568) and Merck’s, known as MSD outside of the United States and Canada, (NYSE: MRK) Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) has been accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck.
The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The FDA is also reviewing the BLA under the Real-Time Oncology Review (RTOR) program and Project Orbis, two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is October 10, 2026.
The BLA is based on results from the IDeate-Lung01 phase 2 trial, with support from the IDeate-PanTumor01 phase 1/2 trial. Results from the primary analysis of IDeate-Lung01 were presented at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25) and published in the Journal of Clinical Oncology. Ifinatamab deruxtecan also was previously granted Breakthrough Therapy Designation by the FDA in August 2025 for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.
“The FDA’s granting of Priority Review for ifinatamab deruxtecan marks a significant milestone in our effort to provide new and innovative treatment options for patients with extensive-stage small cell lung cancer,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “We look forward to continuing to work with the FDA to bring this potential first-in-class B7-H3 directed DXd antibody drug conjugate to patients as quickly as possible.”
“Small cell lung cancer remains one of the toughest cancers to treat, with few options if the disease progresses after standard of care treatments,” said Eliav Barr, MD, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. “The FDA’s acceptance of the BLA reinforces the important role that ifinatamab deruxtecan could play in helping to address the needs of patients with extensive-stage small cell lung cancer.”
About IDeate-Lung01
IDeate-Lung01 is a global, multicenter, randomized, open-label, two-part phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with ES-SCLC who were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. Patients with asymptomatic brain metastases (untreated or previously treated) were eligible to participate.
In the first part of the trial (dose optimization), patients were randomized 1:1 to receive ifinatamab deruxtecan (8 or 12 mg/kg) given intravenously once every three weeks. In the second part of the trial (dose expansion), patients received ifinatamab deruxtecan (12 mg/kg) intravenously at the same dosing interval.
The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), time to response (TTR), overall survival (OS), pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis.
IDeate-Lung01 enrolled 187 patients in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.
About IDeate-PanTumor01
IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label phase 1/2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists.
The phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose and recommended dose for expansion (RDE). The phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous non-small cell lung cancer, metastatic castration-resistant prostate cancer or esophageal squamous cell carcinoma.
The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating ORR, DOR, DCR, PFS, OS and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints also will be assessed.
IDeate-PanTumor01 will enroll approximately 250 patients in Asia and North America. For more information about the trial, visit ClinicalTrials.gov.
About Small Cell Lung Cancer
Approximately 250,000 patients are diagnosed with small cell lung cancer (SCLC) each year globally.1 There were approximately 27,000 new cases of SCLC in the U.S. in 2025, accounting for about 12% of all lung cancer cases.2,3 SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate.4,5 While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches.6,7,8,9
About B7-H3
B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1.10,11 B7-H3 is overexpressed in a wide range of cancer types, including SCLC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target.12,13,14,15 There are currently no B7-H3 directed medicines approved for the treatment of cancer.
About Ifinatamab Deruxtecan
Ifinatamab deruxtecan is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
Ifinatamab deruxtecan was granted Breakthrough Therapy Designation by the FDA for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.
Ifinatamab deruxtecan has been granted Orphan Drug Designation (ODD) by the U.S. FDA, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of SCLC. Ifinatamab deruxtecan also was granted ODD for the treatment of esophageal cancer by the FDA.
About the Ifinatamab Deruxtecan Clinical Development Program
A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan monotherapy and in combination with other cancer medicines across multiple cancers. The program is currently comprised of three phase 3 trials in advanced/metastatic disease, including SCLC (IDeate-Lung02), castration-resistant prostate cancer (IDeate-Prostate01) and esophageal squamous cell carcinoma (IDeate-Esophageal01).
About the Daiichi Sankyo and Merck Collaboration
Daiichi Sankyo and Merck, known as MSD outside of the United States and Canada, entered into a global collaboration in October 2023 to jointly develop and commercialize ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In?August 2024, the global co-development and co-commercialization agreement was expanded to include gocatamig (MK-6070/DS3280), which the companies will jointly develop and commercialize worldwide, except in Japan where Merck & Co., Inc., Rahway, N.J., USA will maintain exclusive rights. Merck & Co., Inc., Rahway, N.J., USA will be solely responsible for manufacturing and supply for gocatamig.
About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.
The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU® and DATROWAY®, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc., Rahway, N.J., USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo.
An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING.
Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.
About Daiichi Sankyo
Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com.
Merck’s Focus on Cancer
Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 20 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit www.merck.com/research/oncology.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
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References:
Wang Q, et al. Journal of Thoracic Oncology. 2023 Jan;18(1):31-46.
National Cancer Institute. SEER Explorer. Cancer Stat Facts: Lung and Bronchus Cancer. Accessed December 2025.
U.S. Centers for Disease Control and Prevention. United States Cancer Statistics. Types of Lung Cancer | U.S. Cancer Statistics | CDC. Accessed December 2025.
Rudin CM, et al. Nat Rev Dis Primers. 2021;7(1):3.
National Cancer Institute. SEER Explorer. Small cell carcinoma of the Lung and Bronchus: 5-year Relative Survival. Accessed January 2026.
American Cancer Society. Treatment Choices for Small Cell Lung Cancer, by Stage. Accessed January 2026.
Liu SV, et al. J Clin Oncol. 2021;39(6):619-30.
Paz-Ares L, et al. ESMO Open. 2022;7(2):100408.
von Pawel J, et al. J Clin Oncol. 2014;32:4012-4019.
Zhao B, et al. J Hematol Oncol. 2022;15(1):153.
Janakiram M, et al. Immunol Rev. 2017;276(1):26-39.
Qiu M-j, et al. Front. Oncol. 2021;11:600238.
Picarda E, et al. Clin Cancer Res. 2016;22(14):3425-3431.
Bendell JC, et al. J Clin Oncol. 2020;39(15 suppl 1). Abstract TPS3646.
Kontos F, et al. Clin Cancer Res. 2021;27(5):1227-1235.
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Media Contacts:
Daiichi Sankyo
Global/US:
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Daiichi Sankyo
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Daiichi Sankyo Co., Ltd.
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Merck
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Julie Cunningham
julie.cunningham@merck.com
Michael McArdle
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Investors:
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(732) 594-1579
Steven Graziano
(732) 594-1583
Original: Ifinatamab Deruxtecan Granted Priority Review in the U.S. for Adult Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer who Experienced Disease Progression on or After Platinum-Based Chemotherapy
US Market News
3月前
European Commission Approves KEYTRUDA® (pembrolizumab) Plus Paclitaxel ± Bevacizumab for the Treatment of Adults With PD-L1 (CPS ≥1) Platinum-Resistant Recurrent Ovarian Carcinoma Who Have Received One or Two Prior Systemic Treatment RegimensApril 2, 2026 6:45 AM
Business Wire
The KEYTRUDA regimen is the first and only PD-1 inhibitor-based treatment approved in the European Union for these patients
Approval supported by data from the Phase 3 KEYNOTE-B96 trial in which the KEYTRUDA regimen demonstrated a statistically significant improvement in progression-free and overall survival compared to placebo plus paclitaxel, with or without bevacizumab
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that KEYTRUDA® (pembrolizumab), in combination with paclitaxel, with or without bevacizumab, is approved in the European Union (EU) for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1 and who have received one or two prior systemic treatment regimens. This approval, which also covers KEYTRUDA SC® [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this regimen the first and only PD-1 inhibitor-based treatment option for eligible patients with platinum-resistant ovarian cancer in the EU.
“Despite recent advances, patients with ovarian cancer face a significant unmet need when their disease progresses and becomes resistant to standard platinum-based therapy,” said Dr. Nicoletta Colombo, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. “The approval of this pembrolizumab-based regimen is an important advance that provides a crucial new treatment option and represents a welcome addition to the treatment landscape for appropriate patients with PD-L1-positive platinum-resistant ovarian cancer across Europe.”
This approval is based on results from the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), in which KEYTRUDA plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the trial’s primary endpoint, and overall survival (OS), a key secondary endpoint, for patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) compared to placebo plus paclitaxel, with or without bevacizumab. The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), received in February 2026.
“We’re proud to bring this KEYTRUDA-based regimen to appropriate patients in Europe with PD-L1-positive platinum-resistant ovarian cancer – giving this community access to the region’s first PD-1 inhibitor treatment approach for this disease,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “This milestone marks real progress for patients and advances our broader mission of expanding access to effective options for women’s cancers globally.”
In the KEYNOTE-B96 trial, KEYTRUDA plus paclitaxel, with or without bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in PFS, reducing the risk of disease progression or death by 28% (HR=0.72 [95% CI, 0.58-0.89]; p=0.0014) in patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) when compared to placebo plus paclitaxel, with or without bevacizumab. For patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) who received the KEYTRUDA-based regimen, median PFS was 8.3 months (95% CI, 7.0-9.4) versus 7.2 months (95% CI, 6.2-8.1) for patients receiving the placebo regimen.
The KEYTRUDA-based regimen also demonstrated a statistically significant and clinically meaningful improvement in OS for patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1), reducing the risk of death by 24% (HR=0.76 [95% CI, 0.61-0.94]; p=0.0053) compared to placebo plus paclitaxel with or without bevacizumab. For patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 (CPS ≥1) who received the KEYTRUDA-based regimen, median OS was 18.2 months (95% CI, 15.3-21.0) versus 14.0 months (95% CI, 12.5-16.1) for patients receiving the placebo regimen.
This approval authorizes marketing of this KEYTRUDA treatment regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Timing for commercial availability of KEYTRUDA for this indication in individual EU countries will depend on multiple factors, including the completion of national reimbursement procedures.
In February 2026, KEYTRUDA plus paclitaxel, with or without bevacizumab, was approved by the U.S. Food and Drug Administration (FDA) to treat adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.
About KEYNOTE-B96/ENGOT-ov65
KEYNOTE-B96, also known as ENGOT-ov65, is a multicenter, randomized, double-blind placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT05116189) sponsored by Merck and conducted in collaboration with the European Network for Gynecologic Oncology Trial (ENGOT) groups investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel), with or without bevacizumab, compared to placebo plus chemotherapy with or without bevacizumab for the treatment of platinum-resistant recurrent ovarian cancer. The primary endpoint is PFS, as assessed by investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS is a key secondary endpoint. The trial enrolled 643 patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma, regardless of PD-L1 tumor expression status, who received one or two prior lines of systemic therapy for ovarian carcinoma, including at least one line of platinum-based chemotherapy. Of the 643 enrolled patients, 72% of patients had tumors expressing PD-L1 (CPS ≥1). Patients were enrolled in KEYNOTE-B96 regardless of PD-L1 tumor expression status. Patients were randomized (1:1) to receive either KEYTRUDA plus paclitaxel, with or without bevacizumab, or placebo plus paclitaxel, with or without bevacizumab. KEYTRUDA (400 mg) or placebo were administered on Day 1 of each six-week treatment cycle and paclitaxel (80 mg/m2) was administered on Days 1, 8 and 15 of each three-week treatment cycle. The option to use bevacizumab was by investigator choice prior to randomization. Bevacizumab (10 mg/kg) was administered on Day 1 of a two-week treatment cycle.
Results from the final analysis of the KEYNOTE-B96 trial evaluating KEYTRUDA plus paclitaxel, with or without bevacizumab, including PFS and OS results for patients with platinum-resistant recurrent ovarian cancer regardless of PD-L1 status, were recently presented at the European Society of Gynaecological Oncology (ESGO) 2026 Congress.
About platinum-resistant ovarian cancer
Ovarian cancer often begins in the fallopian tubes or the ovaries. As of 2022, it is the eighth most commonly diagnosed cancer and the eighth leading cause of cancer death among women worldwide. Globally, there were more than 324,000 patients diagnosed with ovarian cancer and almost 207,000 deaths from the disease in 2022. In many regions, its incidence has been increasing, with estimates projecting a 42% increase in new cases worldwide by 2040. Over 80% of patients diagnosed with ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. Of these patients, approximately 25% will experience disease progression within six months of completing first-line platinum-based chemotherapy – defined as primary platinum-resistant ovarian cancer. Prognosis is particularly poor for these patients and approved treatment options are limited.
About Merck’s research in women’s cancers
Merck is advancing research aimed at expanding treatment options for certain breast and gynecologic (ovarian, cervical and endometrial) cancers, with a goal of improving outcomes for more patients affected by these diseases. Breast cancer and gynecologic cancers are the first and second most commonly occurring cancer types among women worldwide, respectively, and Merck aims to give patients facing these devastating diseases options. With more than 20 clinical trials in nearly 20,000 patients around the world, Merck is driving innovative research to purposefully advance standards of care in women’s cancers. Merck’s research efforts include trials focused on evaluating its medicines in earlier stages, as well as identifying novel mechanisms and new combinations with these treatments. Merck is working to develop a portfolio and pipeline to address the impact of women’s cancers on patients, their families and communities globally.
About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 clinical trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
About KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use, 165 mg + 2,000 units/mL
KEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL).
Selected KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Indications in the U.S.
Ovarian Cancer
KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received 1 or 2 prior systemic treatment regimens.
See additional selected KEYTRUDA and KEYTRUDA QLEX indications in the U.S. after the Selected Important Safety Information.
Selected Important Safety Information for KEYTRUDA and KEYTRUDA QLEX
Contraindications
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients.
Severe and Fatal Immune-Mediated Adverse Reactions
KEYTRUDA and KEYTRUDA QLEX are monoclonal antibodies that belong to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA or KEYTRUDA QLEX in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue KEYTRUDA and KEYTRUDA QLEX depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA and KEYTRUDA QLEX require interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Immune-mediated pneumonitis occurred in 5% (13/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including fatal (0.4%), Grade 3 (2%), and Grade 2 (1.2%) adverse reactions.
Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.
Immune-Mediated Colitis
KEYTRUDA and KEYTRUDA QLEX can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (
US Market News
3月前
Merck Announces Initiation of Pivotal Phase 2b/3 Trial Evaluating MK-8748 (Tiespectus), an Investigational Bispecific Tie2 Agonist/VEGF Inhibitor, for the Treatment of Neovascular Age-Related Macular DegenerationApril 2, 2026 6:50 AM
Business Wire
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of a pivotal Phase 2b/3 trial evaluating MK-8748 (also known as Tiespectus, EYE201), a novel investigational bispecific antibody that directly activates Tie2 signaling and inhibits vascular endothelial growth factor (VEGF), for the treatment of neovascular (wet) age-related macular degeneration (NVAMD).
The study, known as MALBEC, is the first trial of a broader late-phase development program for MK-8748, with a second study in NVAMD scheduled to begin this year (NCT07496567). The decision to advance into pivotal studies is based on results from the Phase 1/2a RIOJA trial (NCT06664502), a two-part study evaluating MK-8748 in patients with either NVAMD, macular edema secondary to branch retinal vein occlusion (BRVO) or diabetic macular edema (DME).
“Despite available therapies, many patients with neovascular age-related macular degeneration remain at risk of further vision loss due to continued vascular leakage,” said Dr. David Guyer, founder, chief executive officer and president, EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA. “With its differentiated dual mechanism directly agonizing Tie2 and inhibiting VEGF, MK-8748 has the potential to offer a novel approach to maintain vascular stability for patients with serious retinal diseases.”
Merck is advancing an ophthalmology pipeline aimed at addressing certain retinal diseases associated with vascular leakage and neovascularization, including NVAMD, DME and macular edema secondary to retinal vein occlusion (RVO). In addition to MK-8748, the company is developing MK-3000 (also known as Restoret, EYE103), an investigational, potentially first-in-class tetravalent, tri-specific antibody that activates the Wingless-related integration site (Wnt) signaling pathway that is being studied in two fully enrolled, ongoing registrational Phase 2b/3 studies for the treatment of DME.
About the MALBEC trial
MALBEC is a randomized, double-masked, pivotal Phase 2b/3 trial (NCT07440225) evaluating the safety and efficacy of two dose levels of intravitreal (IVT) MK-8748 versus active control aflibercept 2mg. Eligible patients will be randomized 1:1:1 to receive two dose regimens of MK-8748 or aflibercept 2mg; participants will initially receive three monthly (Q4W) IVT administrations of MK-8748 or aflibercept, followed by treatments every 8 weeks (Q8W) until week 48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, with the last study visit at week 96. The primary endpoint is mean change in best-corrected visual acuity (BCVA) from baseline to Year 1 in the study eye of the participants, using standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) vision. For further information about the MALBEC trial, please visit www.clinicaltrials.gov.
About neovascular age-related macular degeneration
Neovascular (wet) age-related macular degeneration (NVAMD) is the most common cause of vision loss among older adults, caused by the growth of abnormal blood vessels under the retina. In the United States, it is estimated that nearly 1.5 million people are living with late-stage AMD, including NVAMD.
About MK-8748
MK-8748 (also known as Tiespectus, EYE201) is a novel investigational bispecific antibody with a dual mechanism that directly activates the Tie2 pathway and inhibits VEGF with the goal of stabilizing retinal and choroidal blood vessels and reducing fluid accumulation in the macula. Preclinical and early clinical evidence indicate that dual pathway modulation may help improve vascular stability in the retina and support vision preservation in patients with certain vascular retinal diseases. MK-8748 is currently being studied in a pivotal Phase 2b/3 trial for the treatment of NVAMD, with a second study scheduled to begin this year.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
View source version on businesswire.com: https://www.businesswire.com/news/home/20260401721827/en/
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Carly Myar
carly.myar@merck.com
John Cummins
john.cummins2@merck.com
Investor:
Peter Dannenbaum
(732) 594-1579
Hayley Kasko
(732) 594-4237
Original: Merck Announces Initiation of Pivotal Phase 2b/3 Trial Evaluating MK-8748 (Tiespectus), an Investigational Bispecific Tie2 Agonist/VEGF Inhibitor, for the Treatment of Neovascular Age-Related Macular Degeneration
US Market News
3月前
Positive Data from Phase 2 CADENCE Trial Provides Definitive Proof-of-Concept for WINREVAIR™ (sotatercept-csrk) in Adults With the Syndrome of Combined Post- and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection FractionMarch 29, 2026 11:45 AM
Business Wire
Merck’s WINREVAIR met primary endpoint of change in pulmonary vascular resistance (PVR), significantly improving the ability of blood to flow through the lungs to the heart
Totality of evidence across hemodynamic, functional, echocardiographic and clinical endpoints supports advancing development of WINREVAIR for this distinct patient population into a registrational Phase 3 study
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced detailed results from the Phase 2 CADENCE study, which was designed to evaluate the efficacy, safety and tolerability of two doses (0.3 mg/kg and 0.7 mg/kg) of WINREVAIR™ (sotatercept-csrk) for the treatment of adults with the syndrome of combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF). In this distinct patient population, WINREVAIR showed a statistically significant and clinically meaningful reduction from baseline in pulmonary vascular resistance (PVR) versus placebo (n=55) at week 24, with a 1.02 Wood units reduction for the 0.3 mg/kg dose (n=54, [95% CI, -1.81, -0.23], p=0.004) and a 0.75 Wood units reduction for the 0.7 mg/kg dose (n=55, [95% CI -1.52, 0.03], p=0.024). As noted below, important secondary endpoints explored include six-minute walk distance (6MWD), echocardiographic measures, N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and time to clinical worsening (TTCW). These late-breaking data were presented today in a late-breaking clinical trial presentation at the American College of Cardiology’s Annual Scientific Session and Expo (ACC.26), simultaneously published in Circulation and featured as part of an ACC.26 press conference.
“CpcPH-HFpEF is a distinct, identifiable and well-characterized condition that develops in people with advanced heart failure and typically impacts people who are older and have other comorbid conditions. While it is an uncommon condition and underdiagnosed, it is associated with a high morbidity and mortality rate and there are no approved treatment options specifically for CpcPH-HFpEF,” said Dr. Mardi Gomberg-Maitland, MSc, Walter G. Ross professor of clinical research, director of Pulmonary Hypertension Program, George Washington University School of Medicine and Health Sciences. “The Phase 2 CADENCE study results suggest that WINREVAIR has direct pulmonary vascular and cardiac effects in this distinct population, which may translate to clinically meaningful improvements. These proof-of-concept data provide strong rationale for further evaluation in a Phase 3 study.”
In this Phase 2 study designed to assess proof-of-concept and different doses, patients in the WINREVAIR 0.7 mg/kg arm showed an increase of 5.8 meters in 6MWD that did not reach statistical significance (95% CI, -17.3, 28.9). While subsequent secondary endpoints were not formally tested due to the prespecified hierarchical testing strategy, there was a 20.3-meter increase from baseline in 6MWD in patients treated with WINREVAIR 0.3 mg/kg (95% CI, 1.5, 39.1). Additional findings from the week 24 analysis of these secondary endpoints compared to placebo include:
the reduction in mean pulmonary arterial pressure (mPAP) from baseline was -9.19 for WINREVAIR 0.3 mg/kg (95% CI, -13.00, -5.38) and was -9.22 for WINREVAIR 0.7 mg/kg (95% CI, -12.97, -5.46);
the reduction in pulmonary arterial wedge pressure (PAWP) from baseline was -3.04 for WINREVAIR 0.3 mg/kg (95% CI, -5.77, -0.32) and -2.53 for WINREVAIR 0.7 mg/kg (95% CI, -5.33, 0.28);
the reduction in NT-proBNP levels from baseline was -344 pg/mL for WINREVAIR 0.3 mg/kg (95% CI, -656, -31); and -402 pg/mL for WINREVAIR 0.7 mg/kg (95% CI, -846, 42);
the time to first occurrence of a clinical worsening event was prolonged with WINREVAIR 0.3 mg/kg (HR: 0.18 [95% CI, 0.05, 0.62]) and WINREVAIR 0.7 mg/kg (HR: 0.59 [95% CI, 0.25, 1.36]).
The safety profile observed in CpcPH-HFpEF was generally consistent with the known safety profile for WINREVAIR in pulmonary arterial hypertension (PAH).
“The totality of evidence and consistency in trends across multiple endpoints from the CADENCE study support advancement of WINREVAIR into a registrational Phase 3 program in CpcPH-HFpEF. While both doses suggest efficacy, CADENCE results support that the 0.3 mg/kg dose may optimize the benefit-risk profile of WINREVAIR in the distinct population of CpcPH-HFpEF,” said Dr. Mahesh Patel, vice president, global clinical development, Merck Research Laboratories. “We are working with regulatory agencies to design a Phase 3 registrational study with endpoints that focus on clinical outcomes most relevant to the needs of this population, with the ultimate goal of providing the first treatment option for CpcPH-HFpEF.”
About the CADENCE study and additional results
CADENCE is a double-blind, randomized, placebo-controlled Phase 2 proof-of-concept study (NCT04945460) evaluating the efficacy, safety and tolerability of WINREVAIR versus placebo in adults with CpcPH-HFpEF. Adult patients in the trial had a diagnosis of CpcPH-HFpEF with New York Heart Association (NYHA) FC II or III. The study enrolled 164 participants, and the demographics and clinical characteristics at baseline were generally balanced. The median age was 75 years old (69-79) and 69.5% of the patients were female (n=114). 65.9% of patients had a NYHA FC III diagnosis and 34.1% had a NYHA FC II diagnosis. At baseline, 34.8% had atrial fibrillation and 46.3% had diabetes.
A total of 164 participants were randomized in a 1:1:1 ratio to one of the three treatment groups: placebo once every three weeks (Q3W) (n=55), 0.3 mg/kg WINREVAIR Q3W (n=54) and 0.7 mg/kg WINREVAIR Q3W (n=55) during the placebo-controlled treatment period. For those randomized to the 0.7 mg/kg dose of WINREVAIR, participants received a starting dose level of WINREVAIR 0.3 mg/kg for the initial three dosing visits, then escalated to the 0.7 mg/kg dose Q3W.
The CADENCE trial was designed as a proof-of-concept study with biomarkers, invasive hemodynamics, non-invasive imaging and exercise capacity. The primary endpoint is change from baseline in PVR. The study also evaluated exercise capacity, as well as echocardiographic, biomarker and clinical endpoints. Time to clinical worsening was defined by a composite endpoint of death, ≥1 hospitalization due to cardiopulmonary indication; ≥1 administration of intravenous diuretics or subcutaneous furosemide or ≥15 percent decrease from baseline in 6MWD confirmed by two tests. At baseline, the median PVR was 5.2 Wood units (4.0, 6.9), mPAP was 43 mmHg (38.0, 50.0), PAWP was 21.0 mmHg (18.0, 25.0), the median 6MWD was 273.8 meters (199.5, 343.8), and the median NT-proBNP level was 1119 pg/mL (554-2383).
Serious adverse events (SAEs) were reported in 20% of participants receiving WINREVAIR 0.3 mg/kg, 33% of participants receiving WINREVAIR 0.7 mg/kg and 22% receiving placebo. Adverse events leading to treatment discontinuation were comparable between WINREVAIR 0.3 mg/kg and placebo, with no discontinuations in either group. There were three discontinuations due to an AE and one discontinuation due to a drug-related AE in the WINREVAIR 0.7 mg/kg group. Bleeding events occurred in 26% of patients in the WINREVAIR 0.3 mg/kg group, 27% in the WINREVAIR 0.7 mg/kg group and 24% of patients in the placebo group. Adverse events leading to death occurred in one patient in the WINREVAIR 0.7 mg/kg group and two patients in the placebo group. Adverse events with an incidence of ≥10% in any group included diarrhea, fatigue, peripheral edema, influenza, nasopharyngitis, urinary tract infection, dizziness, headache and dyspnea.
About the syndrome of combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF)
Combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF) is a distinct, identifiable and well-characterized condition that develops in people with long-term or advanced heart failure. Different from Group 1 pulmonary arterial hypertension (PAH), CpcPH-HFpEF is caused by two interrelated components: pulmonary vascular disease and cardiac disease. CpcPH-HFpEF is thought to be uncommon and underdiagnosed, typically impacting people who are older and have other comorbid conditions. It is associated with a worse prognosis and higher mortality rate compared to HFpEF alone. There are no treatments specifically approved for CpcPH-HFpEF.
About WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg
WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling and improved hemodynamics.
WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.
Selected Safety Information for WINREVAIR
WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required.
WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is
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3月前
Merck to Acquire Terns Pharmaceuticals, Inc., Expanding Its Hematology Pipeline With TERN-701, a Novel Candidate for Chronic Myeloid Leukemia (CML)March 25, 2026 6:45 AM
Business Wire
Terns’ lead candidate TERN-701 is an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor currently in Phase 1/2 development for certain patients with CML
Merck to hold investor call at 8 a.m. EDT today
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Terns Pharmaceuticals, Inc. (“Terns”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Terns for $53.00 per share in cash for an approximate equity value of $6.7 billion. This equates to approximately $5.7 billion net of acquired cash and represents an approximate premium of 31% to the 60-day and 42% to the 90-day volume-weighted average stock price on March 24, 2026.
“The acquisition of Terns builds on our growing presence in hematology with TERN-701, a potential best-in-class candidate for the treatment of certain patients with chronic myeloid leukemia,” said Robert M. Davis, chairman and chief executive officer, Merck. “This transaction further diversifies and strengthens our position in oncology as we continue to look for opportunities to broaden our portfolio into other therapeutic areas.”
Terns’ lead candidate, TERN-701, is a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) currently being evaluated in the Phase 1/2 CARDINAL trial (NCT06163430) for patients with Philadelphia chromosome-positive (Ph+), chronic phase chronic myeloid leukemia (CML) previously treated with at least one prior TKI and who experienced treatment failure, suboptimal response or treatment intolerance. In March 2024, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TERN-701 for the treatment of CML.
“This acquisition reflects our team’s deep commitment to innovation in oncology and developing high impact medicines,” said Amy Burroughs, chief executive officer, Terns. “By working together, we will advance TERN-701, leveraging the deep expertise and significant resources at Merck, a global biopharmaceutical leader with a proven track record of delivering cancer breakthroughs for patients who need them most. I am immensely proud of the Terns team and our work towards making a difference for people living with CML. Finally, we extend our heartfelt thanks to the investigators, patients, and community advocates whose dedication and support make the development of TERN-701 possible.”
In clinical trials to date, TERN-701 has shown promising activity, with encouraging rates of major molecular response and deep molecular response observed by week 24. Importantly, this includes responses in patients with high disease burden who previously received multiple lines of therapy, including many who were treated with an allosteric TKI. The majority of treatment-emergent adverse events were reported as low grade with a low incidence of severe adverse events and discontinuations. No clinically meaningful changes in blood pressure have been observed, and rates of lipase elevation have been low.
“The first approval of a BCR::ABL1 tyrosine kinase inhibitor 25 years ago transformed the prognosis for many patients with chronic myeloid leukemia. Despite new therapeutic options, there is significant need for innovative, well-tolerated therapies with faster time to onset of molecular response leading to deeper responses and better disease control,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “Based on early clinical evidence, TERN-701, a novel allosteric BCR::ABL1 inhibitor, may have the potential to provide a meaningfully differentiated option for certain patients living with CML.”
The transaction has been approved by both Merck’s and Terns’ Boards of Directors. Under the terms of the merger agreement, Merck, through a subsidiary, will acquire all of the outstanding shares of Terns. The acquisition is subject to a majority of Terns’ stockholders tendering their shares in a tender offer that will be initiated by a subsidiary of Merck. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to be accounted for as an asset acquisition and close in the second quarter of 2026, resulting in a charge of approximately $5.8 billion, or approximately $2.35 per share, included in both second quarter and full year 2026 GAAP and non-GAAP results.
A copy of the merger agreement for the transaction will be filed with the Securities and Exchange Commission (“SEC”) and will be publicly available free of charge at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by Merck may be obtained at no charge from Merck’s website at www.merck.com or by contacting Merck at 126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ 07065 USA, or (908) 740-4000. Copies of the documents filed with the SEC by Terns may be obtained at no charge from Terns’ website at www.ternspharma.com or by contacting Terns at 1065 East Hillsdale Blvd., Suite 100, Foster City, CA 94404 or (650) 525-5535 Ext.101.
Investor Call
Merck will hold an investor call Wednesday, March 25, 2026 at 8 a.m. EDT to discuss the proposed transaction. Journalists who wish to ask questions should contact a member of Merck’s Global Media Relations team at the conclusion of the call. Investors, journalists and the general public may access a live audio webcast of the call via this weblink.
All participants may join the call by dialing (800) 369-2154 (U.S. and Canada Toll-Free) or (517) 308-9422 and using the access code 8711041.
Advisors
Centerview Partners LLC and Jefferies LLC acted as financial advisors to Terns and Freshfields LLP acted as Terns’ legal advisor.
About TERN-701
TERN-701 is a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) designed to bind to the ABL myristoyl pocket, with a potentially best-in-disease profile that could improve upon the efficacy, safety and convenience of existing treatments for CML.
About the CARDINAL study
TERN-701 is currently being evaluated in the CARDINAL trial (NCT06163430), a global multi-center dose escalation and dose-expansion clinical trial to assess safety, tolerability and efficacy in patients with Philadelphia chromosome-positive (Ph+) chronic phase CML previously treated with at least one prior TKI and experienced treatment failure, suboptimal response, or treatment intolerance. The dose escalation portion of the CARDINAL trial completed in January 2025 with no dose limiting toxicities observed up to the maximum dose of 500mg QD. Terns initiated the dose expansion portion of the trial in April 2025 with patients randomized to one of two dose cohorts (320mg or 500mg QD) with up to 40 patients per arm. In January 2026, an additional cohort was added to the CARDINAL trial to evaluate TERN-701 500 mg QD in approximately 20 patients with BCR::ABL1 resistance mutations including T315I, M244V, F359I/C/V and others.
About chronic myeloid leukemia
Chronic myeloid leukemia (CML) is a slow growing type of blood cancer that leads to an overproduction of white blood cells that accumulate in the blood and bone marrow, disrupting the production of healthy blood cells. CML is commonly associated with the Philadelphia chromosome, a translocation between chromosomes 9 and 22 that results in constitutive activation of the BCR::ABL1 fusion protein, which fuels cancer growth.
About Merck in hematology
Merck is advancing a pipeline of hematology candidates targeting a diverse range of targets across leukemias, lymphomas and myeloproliferative neoplasms. Candidates in Phase 3 development include: bomedemstat (MK-3543), an investigational, orally available lysine-specific demethylase 1 (LSD1) inhibitor; nemtabrutinib (MK-1026), an investigational, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor; and zilovertamab vedotin (MK-2140), an investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1). Additionally, MK-1045, an investigational CD19xCD3 T-cell engager, is currently being evaluated in a Phase 1b/2 trial.
About Terns Pharmaceuticals
Terns Pharmaceuticals is a clinical-stage oncology company reimagining known biology to deliver high impact medicines. Terns’ lead program, TERN-701, is a highly selective, oral, allosteric BCR::ABL1 inhibitor with a potentially best-in-disease profile that could meaningfully improve upon the efficacy, safety and convenience of existing treatments for chronic myeloid leukemia. For more information, please visit: www.ternspharma.com.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA and Terns Pharmaceuticals, Inc., Foster City, Calif., USA
This release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) and Terns contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expects,” “intends,” “believes,” “may,” “plan” or “will.” Forward-looking statements in this release include, but are not limited to, statements related to the potential benefits of and future plans for TERN-701; the ability of the company and Terns to complete the transactions contemplated by the transaction agreement, including the parties’ ability to satisfy the conditions to the consummation of the transaction contemplated thereby, statements about the expected timetable for completing the transaction, the company’s and Terns’ beliefs and expectations and statements about the benefits sought to be achieved in the company’s proposed acquisition of Terns, the potential effects of the acquisition on both the company and Terns, and the possibility of any termination of the transaction agreement.
Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Terns’ clinical studies and other risks related to clinical development, delays in or unanticipated action by regulatory authorities, risks related to government contracts, having to use cash in ways other than as expected and other risks, uncertainties associated with Terns’ business in general; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the proposed transaction contained in the transaction agreement may not be satisfied or waived (including, but not limited to, the failure to obtain a sufficient number of tendered shares from Terns’ shareholders); the effects of disruption from the transactions contemplated by the transaction agreement and the impact of the announcement and pendency of the transactions on Terns’ business; the risk that shareholder litigation in connection with the transaction may result in significant costs of defense, indemnification and liability; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Neither Terns nor Merck undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s Annual Report on Form 10-K for the year ended December 31, 2025, Terns’ Annual Report on Form 10-K for the year ended December 31, 2024, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings subsequently made with the SEC available at the SEC’s Internet site (www.sec.gov).
ADDITIONAL INFORMATION REGARDING THE PROPOSED TRANSACTION
The tender offer described in this release has not yet commenced. This release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Terns or any other securities, nor is it a substitute for the tender offer materials described herein. At the time the planned tender offer is commenced, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed by Merck and Thailand Merger Sub, Inc. with the SEC, and a solicitation/recommendation statement on Schedule 14D-9 will be filed by Terns with the SEC.
INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES, INCLUDING THE TERMS AND CONDITIONS OF THE OFFER.
Investors and security holders may obtain a free copy of the Offer to Purchase, the related Letter of Transmittal, other tender offer documents and the Solicitation/Recommendation Statement (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the tender offer, which will be named in the tender offer statement. In addition, Merck and Terns file annual, quarterly and current reports and other information with the SEC, which are available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by Merck may be obtained at no charge on Merck’s internet website at www.merck.com or by contacting Merck at 126 East Lincoln Avenue P.O. Box 2000, Rahway, NJ 07065 USA, or by phone at (908) 740-4000. Copies of the documents filed with the SEC by Terns may be obtained at no charge from Terns’ internet website at www.ternspharma.com or by contacting Terns at 1065 East Hillsdale Blvd., Suite 100, Foster City, CA 94404 or (650)-525-5535 Ext.101.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260325654199/en/
Merck Investor:
Peter Dannenbaum
(732) 594-1579
Steven Graziano
(732) 594-1583
Merck Media:
John Cummins
john.cummins2@merck.com
Carly Myar
carly.myar@merck.com
Terns Investor:
Justin Ng
investors@ternspharma.com
Terns Media:
Jenna Urban
media@ternspharma.com
Original: Merck to Acquire Terns Pharmaceuticals, Inc., Expanding Its Hematology Pipeline With TERN-701, a Novel Candidate for Chronic Myeloid Leukemia (CML)
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