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7日前
Robust Phase 2b Efficacy and Favorable Tolerability Support Monthly Dosing for Pfizer’s GLP-1 RA BerobenatideJune 6, 2026 9:00 AM
Business Wire Results from multiple Phase 2b dose finding studies for berobenatide (PF’3944) highlight a potential first-in-class monthly GLP-1 receptor agonist (GLP-1 RA) peptide, and support the planned Phase 3 low, medium and high dosing strategy VESPER-1 achieved a non-placebo-adjusted weight loss of almost 16% with no plateau observed at 32 weeks on 2.4 mg weekly berobenatide Pfizer plans to advance 10 Phase 3 studies for berobenatide in 2026 for chronic weight management and obesity-related comorbidities including knee osteoarthritis and obstructive sleep apnea, as part of a broader program of 20+ obesity trials Pfizer Inc. (NYSE: PFE) today presented detailed results from multiple Phase 2b studies of berobenatide (PF’3944), an investigational, potential first-in-class monthly GLP-1 receptor agonist (GLP-1 RA) peptide, during a late-breaking expert symposium at the 86th Scientific Sessions of the American Diabetes Association (ADA). The objectives for the Phase 2 studies were to identify the right doses for Phase 3 and to test escalation schemes. Across both weekly and monthly dosing in participants with obesity or overweight, with and without type 2 diabetes, the data from the Phase 2b VESPER-1, 2 and 3 studies: provide proof of concept for berobenatide as a potential first-in-class monthly GLP-1 RA peptide that can deliver competitive weight loss; show favorable tolerability for berobenatide, including low gastrointestinal (GI) adverse events and discontinuations despite rapid dose escalation and no allowed step-down; and highlight the potential for monthly delivery in a patient-friendly presentation with a very low 0.5 mL injection volume that provides convenience and scalability advantages. The first clinical experience with the top weekly dose for berobenatide is being presented today for the first time. Results from a 32-week exploratory extension (Part B) of the Phase 2b VESPER-1 study showed a non-placebo-adjusted weight loss of 15.9%* with no plateau observed at 32 weeks on berobenatide (Week 60 of the overall study), in participants who escalated from placebo to 2.4 mg weekly berobenatide. VESPER-1 is evaluating once-weekly berobenatide in adults with obesity or overweight, including Part B to assess the durability of weight loss and the impact of transitioning from once-weekly to less frequent dosing regimens, including once-monthly. "In Phase 2b studies, berobenatide delivered continuous, uninterrupted weight loss at all doses selected for Phase 3, while preserving a tolerable profile as people transitioned from a weekly to a monthly maintenance dose,” said Jim List, MD, PhD, Chief Internal Medicine Officer, Pfizer. “These data highlight the potential for berobenatide to be the first approved monthly GLP-1 RA peptide and support our extensive Phase 3 program that includes 10 studies for chronic weight management and obesity-related comorbidities. With berobenatide as a potential foundational metabolic medicine, both as a single agent and as a combination backbone, Pfizer is advancing a differentiated pipeline with multiple mechanisms and modalities designed to meet the many needs of people living with obesity and related conditions.” Detailed results from the previously reported Phase 2b VESPER-3 study are also being presented today, which is evaluating monthly maintenance dosing of berobenatide in adults with obesity or overweight without type 2 diabetes. In addition, data from the Phase 2b VESPER-2 study, which evaluated weekly dosing of berobenatide in adults with obesity or overweight and type 2 diabetes, showed dose dependent reductions from baseline were observed with berobenatide for both body weight and HbA1c. Of note, there was a 2.2%** reduction in HbA1c achieved with berobenatide 1.6 mg weekly at week 28 (on treatment [efficacy] estimand), compared to a reduction of 0.2% in the placebo group. "Weight management is a lifelong commitment, and the barriers to staying on therapy long-term are just as important as the therapy itself,” said John B. Buse, MD, PhD, Professor of Medicine at the University of North Carolina School of Medicine, Chapel Hill. “The growing body of evidence shows berobenatide delivering meaningful weight loss with a well-tolerated profile following a switch from weekly to monthly dosing in Phase 2b studies. If approved, berobenatide has the potential to not only be effective, but practical and sustainable in real life." The VESPER-6 pivotal Phase 3 study investigating monthly maintenance dosing for berobenatide in adults with obesity or overweight is open for enrollment, as well as the SOLIS-1 Phase 2b study investigating weekly and monthly maintenance dosing of an ultra-long-acting amylin analog (PF'3945) as a monotherapy and in combination with berobenatide. An investor slide presentation with more information about the VESPER clinical development program and the clinical trial results contained in this release will be available on Pfizer’s web site at 10:00 a.m. CT / 11:00 a.m. ET at www.pfizer.com/investors. About Berobenatide and Pfizer’s Cardiometabolic Pipeline Pfizer plans to advance 20+ trials for obesity and related comorbidities in 2026. This includes 10 ongoing and planned Phase 3 trials for berobenatide (PF’3944), an investigational, potential first-in-class monthly GLP-1 receptor agonist (GLP-1 RA) peptide being studied for chronic weight management and obesity-related comorbidities including knee osteoarthritis and obstructive sleep apnea. The growing body of evidence supports advancing an extensive development program for berobenatide as a monotherapy and in combination with various Nutrient-Stimulated Hormone (NuSH) peptides including amylin analogs. About the VESPER Clinical Development Program The VESPER clinical development program is a comprehensive global program evaluating berobenatide across a range of patient populations and dosing regimens in chronic weight management. Phase 2b VESPER studies include: VESPER-1: A Phase 2b trial in adults with obesity or overweight evaluating once-weekly berobenatide, including a 32-week exploratory extension (Part B) assessing the durability of weight loss and the impact of transitioning from once-weekly to less frequent dosing regimens, including once-monthly administration. Part A was the initial 28-week double-blind placebo-controlled portion of the study. VESPER-2: A Phase 2b randomized, double-blind, placebo-controlled trial evaluating once- weekly berobenatide in adults with obesity or overweight and type 2 diabetes, designed to assess weight loss, glycemic control and safety in this population. VESPER-3 is an ongoing 64-week, randomized, double-blind, placebo-controlled study in participants with obesity or overweight without type 2 diabetes. The study is designed to evaluate weekly (QW) titration phase to monthly (QM) dosing of berobenatide in four different titration and QM dose arms, compared to placebo. Phase 3 VESPER studies include: VESPER-4 is an ongoing Phase 3 pivotal study investigating once-weekly berobenatide in adults with obesity or overweight and without type 2 diabetes. VESPER-5 is an ongoing Phase 3 pivotal study investigating once-weekly berobenatide in adults with obesity or overweight and type 2 diabetes. A higher weekly dose of berobenatide (2.4 mg) is currently being evaluated in Phase 3. VESPER-6 is a Phase 3 pivotal study investigating once-monthly berobenatide in adults with obesity or overweight. The study is now open for enrollment. Seven additional planned Phase 3 studies of berobenatide are designed to target comorbidities and increase patient optionality and access. About Obesity Obesity is a growing global epidemic. In 2015, it was estimated that approximately 1.9 billioni people were living with obesity or considered overweight, and this number is expected to grow to more than 2.9 billion by 2030.ii Obesity is a complex metabolic disease, often defined in adults as having a body mass index (BMI) greater than or equal to 30.iii It is associated with more than 200 health conditions,iv contributing to significant chronic disease burden, shortened lifespans, and growing healthcare costs. Despite recent advances in care, for many patients, current therapies are not sufficient—whether due to limited efficacy, tolerability issues that impact adherence, co-morbidities that weight loss alone doesn’t address, or barriers to access and affordability. New waves of innovation that better meet the diverse needs of patients are critical to effectively address this epidemic. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For over 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Disclosure Notice The information contained in this release is as of June 6, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about berobenatide (PF’3944; previously called MET-097i), an investigational, potential first-in-class monthly GLP-1 receptor agonist (GLP-1 RA) peptide, and results and expectations from Phase 2b VESPER studies, including the VESPER-1 exploratory extension, VESPER-2, and VESPER-3, the potential of berobenatide to be the first approved monthly GLP-1 receptor agonist peptide, potential product profile and positioning, Pfizer’s investigational cardiometabolic pipeline, and anticipated clinical trial starts and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data, including the risk that analysis of longer term data does not match our expectations based on the data disclosed in this release; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities, including the population regulatory authorities deem relevant for regulatory decisions; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications may be filed in any jurisdictions for berobenatide or any other product candidates for any potential indications; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether berobenatide or any such other product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of berobenatide or any such other product candidates; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. _________________ * Data are arithmetic means ** Least squares means calculated using a mixed model for repeated measures excluding protocol-defined intercurrent events (i.e., on-treatment estimand). i World Obesity Atlas 2025 ii American Medical Association iii World Health Organization. Obesity and Overweight. Accessed June 9, 2025. https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. iv American Medical Association. Obesity. https://www.ama-assn.org/topics/obesity. View source version on businesswire.com: https://www.businesswire.com/news/home/20260605120877/en/ Media Contact: PfizerMediaRelations@Pfizer.com Investor Contact: IR@Pfizer.com Original: Robust Phase 2b Efficacy and Favorable Tolerability Support Monthly Dosing for Pfizer’s GLP-1 RA Berobenatide
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2週前
Pfizer’s BRAFTOVI Regimen Nearly Doubles Median Progression-Free Survival in Metastatic Colorectal CancerMay 31, 2026 8:00 AM
Business Wire Cohort 3 analysis from the Phase 3 BREAKWATER study showed a 56% reduction in the risk of disease progression or death compared to traditional chemotherapy regimen Overall survival benefit was also observed, with a 44% reduction in the risk of death BRAFTOVI in combination with cetuximab and fluorouracil-based chemotherapy is the only approved targeted regimen for BRAF V600E-mutant metastatic colorectal cancer Pfizer Inc. (NYSE: PFE) today announced detailed progression-free and overall survival results from Cohort 3, a randomized cohort of the Phase 3 BREAKWATER trial, evaluating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and FOLFIRI (fluorouracil, leucovorin, and irinotecan) versus FOLFIRI with or without bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. These results will be presented today in a late-breaking oral presentation (Abstract LBA3503) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the Annals of Oncology. As previously reported, Cohort 3 met its primary endpoint of objective response rate (ORR) by blinded independent central review (BICR). Results for the key secondary endpoint of progression-free survival (PFS) by BICR, being presented at ASCO, show median PFS was nearly doubled with the BRAFTOVI combination regimen (15.2 months) versus the comparator (8.3 months). A clinically meaningful and statistically significant 56% reduction in the risk of disease progression or death was observed for patients treated with the BRAFTOVI combination regimen versus the comparator (Hazard Ratio [HR] of 0.44; 95% Confidence Interval [CI], 0.27–0.70; p=0.0002). Updated overall survival (OS), a descriptive secondary endpoint, showed a 44% reduction in the risk of death for patients treated with the BRAFTOVI combination regimen versus the comparator (HR of 0.56; 95% CI, 0.34–0.94) with a median follow-up of approximately 20 months for both arms. At 18 months, 72% of patients receiving the BRAFTOVI combination regimen were expected to be alive compared to 54.5% of patients receiving the comparator. Median OS was not reached for the BRAFTOVI combination regimen versus a median of 20.3 months for the comparator. “For people with BRAF V600E-mutant metastatic colorectal cancer – a disease that historically has had no targeted treatment options and poor outcomes – these results strengthen confidence in how we can treat this disease,” said Scott Kopetz, M.D., Ph.D., FACP, Professor and Deputy Chair of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and co-principal investigator of the BREAKWATER trial. “A nearly 60% reduction in risk of disease progression or death, combined with prolonged overall survival, reinforces the role of encorafenib in combination with cetuximab and FOLFIRI as a standard of care in the first-line setting for this patient population.” "These compelling results add to a robust body of evidence demonstrating the efficacy of the BRAFTOVI combination treatment across two different established chemotherapy regimens in BRAF V600E-mutant metastatic colorectal cancer,” said Jeff Legos, Chief Oncology Officer, Pfizer. “These findings reaffirm the established role of the BRAFTOVI combination regimen as a cornerstone of first-line treatment for patients and families facing this challenging diagnosis.” In this Cohort 3 analysis, the safety profile of BRAFTOVI in combination with cetuximab and FOLFIRI continued to be consistent with the known safety profile of each respective agent in the regimen, and no new safety signals were identified. The most common adverse events (AEs) (≥25%) in the BRAFTOVI regimen were nausea, diarrhea, vomiting, anemia, alopecia, fatigue, decreased neutrophil count, constipation, decreased appetite, neutropenia, arthralgia, asthenia, and abdominal pain. Grade ≥3 AEs (all causality) occurred in 70.4% of patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI compared to 80.9% of patients receiving FOLFIRI with or without bevacizumab. Treatment discontinuation occurred in 15.5% of patients receiving the BRAFTOVI combination compared to 10.3% for those receiving FOLFIRI. Based on the totality of the Phase 3 and Cohort 3 data in the BREAKWATER study, BRAFTOVI in combination with cetuximab and fluorouracil-based chemotherapy received full approval with an expanded indication from the U.S. Food and Drug Administration (FDA) for patients with BRAF V600E-mutant mCRC in February 2026, offering flexibility in chemotherapy regimen used. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries. About BREAKWATER
BREAKWATER is a Phase 3, randomized, active-controlled, open-label, multicenter trial of BRAFTOVI with cetuximab, alone or in combination with chemotherapy (mFOLFOX6 or FOLFIRI) in participants with previously untreated BRAF V600E-mutant mCRC. Patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab (discontinued after randomization of 158 patients), BRAFTOVI 300 mg orally once daily in combination with cetuximab and mFOLFOX6 (n=236) or mFOLFOX6, FOLFOXIRI, or CAPOX, with or without bevacizumab (control arm) (n=243). The dual primary endpoints for these study groups are ORR and PFS as assessed by BICR. OS is a key secondary endpoint. In Cohort 3, patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab and FOLFIRI (n=73) or FOLFIRI, with or without bevacizumab (control-arm) (n=74). The primary endpoint of Cohort 3 is ORR as assessed by BICR. PFS as assessed by BICR is a key secondary endpoint; OS is a secondary endpoint. About Colorectal Cancer (CRC)
CRC is the third most common type of cancer in the world, with approximately 1.8 million new diagnoses in 2022.1 It is the second leading cause of cancer-related deaths.2 Overall, the lifetime risk of developing CRC is about 1 in 24 for men and 1 in 26 for women.2 In the U.S. alone, an estimated 158,850 people will be diagnosed with cancer of the colon or rectum in 2026, and approximately 55,000 are estimated to die from the disease each year.3 For 20% of those diagnosed with CRC, the disease has metastasized, or spread, making it harder to treat, and up to 50% of patients with localized disease eventually develop metastases.4 BRAF mutations are estimated to occur in 8-12% of people with mCRC and are associated with a poor prognosis for these patients.5 The BRAF V600E mutation is the most common BRAF mutation, and the risk of mortality in CRC patients with the BRAF V600E mutation is more than double that of patients with no known mutation present.5-7 Despite the high unmet need in BRAF V600E-mutant mCRC, prior to the BRAFTOVI accelerated FDA approval in this indication on December 20, 2024, there were no approved biomarker-driven therapies specifically indicated for people with previously untreated BRAF V600E-mutant mCRC.8,9 About BRAFTOVI® (encorafenib)
BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including CRC. Pfizer has exclusive rights to BRAFTOVI in the U.S., Canada, Latin America, Middle East, and Africa. Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel, and Pierre Fabre Laboratories has exclusive rights to commercialize the product in all other countries, including Europe and Asia (excluding Japan and South Korea). INDICATION AND USAGE
BRAFTOVI® (encorafenib) is indicated, in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC. IMPORTANT SAFETY INFORMATION
Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 and FOLFIRI for recommended dosing and additional safety information. WARNINGS AND PRECAUTIONS New Primary Malignancies: New primary malignancies, cutaneous and noncutaneous, can occur. In the BREAKWATER trial, the following cutaneous malignancies occurred in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6: melanocytic nevus in 5.6%, skin papilloma in 3%, basal cell carcinoma in 1.3%, squamous cell carcinoma of skin in 0.9%, keratoacanthoma in 0.4% and malignant melanoma in situ in 0.4%. In patients who received BRAFTOVI in combination with cetuximab and FOLFIRI, skin papilloma occurred in 2.8% and keratoacanthoma in 1.4% of patients. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Dose modification is not recommended for new primary cutaneous malignancies. Based on its mechanism of action, BRAFTOVI may promote malignancies associated with activation of RAS through mutation or other mechanisms. Monitor patients receiving BRAFTOVI for signs and symptoms of noncutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive noncutaneous malignancies. Monitor patients for new malignancies prior to initiation of treatment, while on treatment, and after discontinuation of treatment. Tumor Promotion in BRAF Wild-Type Tumors: In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation using an FDA-authorized test prior to initiating BRAFTOVI. Cardiomyopathy: Cardiomyopathy manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ejection fraction, has been reported in patients. Assess left ventricular ejection fraction (LVEF) by echocardiogram or multigated acquisition (MUGA) scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. The safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal (LLN). Patients with cardiovascular risk factors should be monitored closely. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. Hepatotoxicity: Hepatotoxicity can occur. In the BREAKWATER trial, the incidence of Grade 3 or 4 increases in liver function laboratory tests in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6 was 2.6% for alkaline phosphatase, 1.3% each for ALT and AST. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, the incidence of Grade 3 or 4 increases in liver function laboratory tests was 1.5% each for ALT and AST. Monitor liver laboratory tests before initiation of BRAFTOVI, monthly during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. Hemorrhage: Hemorrhage can occur. In the BREAKWATER trial, hemorrhage occurred in 34% of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6; Grade 3 or 4 hemorrhage occurred in 3% of patients. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, hemorrhage occurred in 21% of patients. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. Uveitis: Uveitis, including iritis and iridocyclitis, has been reported in patients treated with BRAFTOVI. In BREAKWATER, the incidence of uveitis among patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6 was 0.4%. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction. QT Prolongation: BRAFTOVI is associated with dose-dependent QTc interval prolongation in some patients. In the BREAKWATER trial, an increase of QTcF >500 ms was measured in 4% (9/226) of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, an increase of QTcF >500 ms was measured in 1.5% (1/65) of patients. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms. Embryo-Fetal Toxicity: BRAFTOVI can cause fetal harm when administered to pregnant women. BRAFTOVI can render hormonal contraceptives ineffective. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose. Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with cetuximab and mFOLFOX6 or FOLFIRI. Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 and FOLFIRI for additional risk information. Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the final dose. Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility. ADVERSE REACTIONS BRAF V600E mutation-positive mCRC, in combination with cetuximab and mFOLFOX6 Serious adverse reactions occurred in 46% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Serious adverse reactions in >3% of patients included intestinal obstruction (4.7%), pyrexia (3.9%), sepsis (3.4%), and abdominal pain (3.4%) Fatal intestinal obstruction occurred in 0.9%, and fatal large intestinal perforation and gastrointestinal perforation occurred in 0.4% (each) in patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6 Most common adverse reactions (≥25%, all grades) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab), and a subset of the control arm (mFOLFOX6 ± bevacizumab), respectively were: peripheral neuropathy (64% vs 53% and 57%), nausea (54% vs 50% and 44%), fatigue (53% vs 41% and 45%), diarrhea (42% vs 50% and 44%), decreased appetite (38% vs 27% and 30%), rash (36% vs 6% and 5%), vomiting (36% vs 22% and 17%), hemorrhage (34% vs 21% and 15%), abdominal pain (32% vs 31% and 30%), arthralgia (32% vs 6% and 7%), pyrexia (29% vs 16% and 17%), and constipation (27% vs 23% and 25%) Most common laboratory abnormalities(≥10%, grade 3 or 4) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab), and a subset of the control arm (mFOLFOX6 ± bevacizumab), respectively were: increased lipase (53% vs 28% and 23%), decreased neutrophil count (37% vs 35% and 33%), decreased hemoglobin (19% vs 6% and 7%), decreased white blood cell count (12% vs 8% and 6%), and increased glucose (11% vs 2% and 1%) BRAF V600E mutation-positive mCRC, in combination with cetuximab and FOLFIRI Serious adverse reactions occurred in 39% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI. Serious adverse reactions in >3% of patients included febrile neutropenia (5.6%) and infusion related reaction (4.2%) Fatal gastrointestinal perforation occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI Most common adverse reactions (>25%, all grades) in the BRAFTOVI with cetuximab and FOLFIRI arm compared to the control arm (FOLFIRI ± bevacizumab) were nausea (61% vs 57%), diarrhea (55% vs 49%), fatigue (47% vs 50%), vomiting (47% vs 31%), alopecia (35% vs 22%), constipation (31% vs 29%), abdominal pain (30% vs 22%), decreased appetite (30% vs 32%), and rash (27% vs 1.5%) Most common laboratory abnormalities (≥10%, grade 3 or 4) in the BRAFTOVI with cetuximab and FOLFIRI arm compared to the control arm (FOLFIRI ± bevacizumab) were: decreased neutrophil count (30% vs 32%), increased lipase (22% vs 12%), decreased white blood cell count (20% vs 6%), and decreased hemoglobin (10% vs 3%) DRUG INTERACTIONS
Strong or moderate CYP3A4 inhibitors: Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose. Strong CYP3A4 inducers: Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers. Sensitive CYP3A4 substrates: Avoid the coadministration of BRAFTOVI with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. If the coadministration cannot be avoided, see the CYP3A4 substrate product labeling for recommendations. Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI. Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval. View the full Prescribing Information. About Pfizer Oncology
At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Disclosure Notice
The information contained in this release is as of May 31, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about BRAFTOVI® (encorafenib) and results from Cohort 3 of the Phase 3 BREAKWATER trial, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BRAFTOVI plus cetuximab and fluorouracil-based chemotherapy; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications may be filed in any additional jurisdictions for BRAFTOVI plus cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic CRC with a BRAF V600E mutation or in any jurisdictions for any other potential indications for BRAFTOVI; whether and when any such other applications may be approved by other regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether BRAFTOVI plus cetuximab and fluorouracil-based chemotherapy will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BRAFTOVI or BRAFTOVI plus cetuximab and fluorouracil-based chemotherapy; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. ERBITUX® is a registered trademark of Eli Lilly and Company its subsidiaries, or affiliates. References American Cancer Society. Global Cancer Facts & Figures 5th Edition. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-2024.pdf. Last accessed: May 2026. American Cancer Society. Key Statistics for Colorectal Cancer. Available at: https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html. Last accessed: May 2026. American Cancer Society. Cancer Facts & Figures 2026. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2026/2026-cancer-facts-and-figures.pdf. Last accessed: May 2026. Ciardiello F, Ciardiello D, Martini G, et al. Clinical management of metastatic colorectal cancer in the era of precision medicine. CA Cancer J Clin. 2022;72:372–40. Tabernero J, Ros J, Élez E. The evolving treatment landscape in BRAF-V600E–mutated metastatic colorectal cancer. Am Soc Clin Oncol Educ Book. 2022;42:254-263. doi:10.1200/EDBK_349561 Ardekani GS, Jafarnejad SM, Tan L, et al. The prognostic value of BRAF mutation in colorectal cancer and melanoma: A systematic review and meta-analysis. PLoS ONE. 2012;7(10):e47054. Schirripa M, Biason P, Lonardi S, et al. Class 1, 2, and 3BRAF-mutated metastatic colorectal cancer: A detailed clinical, pathologic, and molecular characterization. Clin Cancer Res. 2019;25(13):3954-3961. doi:10.1158/1078-0432.CCR-19-0311 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer. V.5.2025 © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed November 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. Cervantes A, Adam R, Roselló S, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(1):10-32. View source version on businesswire.com: https://www.businesswire.com/news/home/20260531990280/en/ Media Contact:
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IR@Pfizer.com Original: Pfizer’s BRAFTOVI Regimen Nearly Doubles Median Progression-Free Survival in Metastatic Colorectal Cancer
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TALZENNA Plus XTANDI Improves Radiographic Progression-Free Survival by More Than 50% in Metastatic Prostate CancerMay 30, 2026 8:00 AM
Business Wire First PARP inhibitor + ARPI combination to show consistent rPFS improvement in HRR gene-altered metastatic hormone-sensitive prostate cancer, including both BRCA and non-BRCA alterations There was an estimated 77% probability of remaining progression-free at three years with TALZENNA plus XTANDI Detailed results from pivotal TALAPRO-3 study presented at ASCO 2026 and published in The New England Journal of Medicine Pfizer Inc. (NYSE: PFE) today announced detailed results from the pivotal Phase 3 TALAPRO-3 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC). These results will be presented today in a late-breaking oral presentation (Abstract LBA5007) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine. TALZENNA plus XTANDI demonstrated a 52% reduction in the risk of radiographic progression or death compared to placebo plus XTANDI (Hazard Ratio [HR] of 0.48; 95% Confidence Interval [CI], 0.36–0.65; p ? 0.0001). At three years, radiographic progression-free survival (rPFS) rates were estimated at 77% in patients treated with TALZENNA plus XTANDI versus 56% in patients treated with placebo plus XTANDI. With a median follow-up of over 37 months, median rPFS was not reached in the TALZENNA plus XTANDI arm and was 46 months with placebo and XTANDI. The rPFS benefit observed with TALZENNA plus XTANDI was consistent across pre-specified groups with various patient and disease characteristics, including age, Gleason score, geographic region, prostate-specific antigen (PSA) level, and BRCA vs. non-BRCA HRR gene alteration status. At three years, rPFS rates were estimated at 77% vs. 49% in patients with cancer harboring BRCA alterations (HR, 0.37; 95% CI, 0.22–0.61) and 76% vs. 60% in patients with cancer with non-BRCA alterations (HR, 0.57; 95% CI, 0.39–0.82), compared with placebo plus XTANDI. “Delaying progression to castration-resistant disease, the most symptomatic and lethal phase of prostate cancer, remains a significant challenge to patients with mCSPC – especially to those with HRR gene alterations, who often experience poorer outcomes,” said Neeraj Agarwal, M.D., FASCO, Presidential Chair of Cancer Research at Huntsman Cancer Institute at the University of Utah and global lead investigator for TALAPRO-3. “With more than three years of follow-up and median radiographic progression-free survival not reached, TALZENNA plus XTANDI demonstrated durable disease control across a broad HRR-altered population, including patients with BRCA and non-BRCA alterations. These findings underscore the importance of genetic testing as part of routine care and highlight the potential for TALZENNA plus XTANDI to meaningfully improve the outcomes of patients with HRRm mCSPC.” Interim overall survival (OS) results showed a strong trend toward improved OS, a key secondary endpoint, with median OS not reached in either treatment arm (HR, 0.77; 95% CI, 0.56–1.04; p = 0.09). TALZENNA plus XTANDI also improved time to PSA progression (HR, 0.51; 95% CI, 0.37–0.71; p < 0.0001) and time to subsequent anti-cancer therapy (HR, 0.51; 95% CI, 0.38–0.70; p < 0.0001) vs. placebo plus XTANDI. The trial remains ongoing, and OS will be formally assessed at the final analysis. In TALAPRO-3, the safety profile of TALZENNA plus XTANDI was consistent with the known profiles of each agent, and no new safety signals were identified. The most common treatment-emergent adverse events (TEAEs) in the TALZENNA plus XTANDI group were anemia, fatigue, decreased neutrophil count, and asthenia. The most common grade 3 or higher TEAE was anemia, reported by 51% in the TALZENNA plus XTANDI group and 3% in the control group. Five percent of patients discontinued TALZENNA due to anemia. TEAEs were generally manageable with dose modifications and supportive care as needed. “Men with HRR gene-mutated metastatic prostate cancer face significant challenges, with faster disease progression and limited treatment options, making it critical to intervene as early in the course of disease as possible,” said Jeff Legos, Chief Oncology Officer, Pfizer. “The benefit seen with TALZENNA plus XTANDI across a full spectrum of HRR gene alterations reinforces its potential to fundamentally change clinical practice, giving patients significantly more time before disease progression as compared to the current standard of care." Prostate cancer is the second most common cancer in men worldwide, with an estimated 1.5 million new cases diagnosed globally1 and 330,000 new cases anticipated in the United States in 2026.2 mCSPC is a form of advanced prostate cancer that has spread beyond the prostate but is still sensitive to androgen deprivation therapy.3 Approximately 5–10% of newly diagnosed cases are mCSPC,4,5 and up to 30% of these patients harbor HRR gene alterations.6 TALZENNA plus XTANDI in HRR gene-mutated mCSPC is an investigational treatment regimen. The results from TALAPRO-3 are being discussed with global health authorities to potentially expand the combination regimen’s existing indication. TALZENNA plus XTANDI is currently approved in more than 60 countries, including in the U.S. for adults with HRR gene-mutated mCRPC and in the European Union for adults with mCRPC in whom chemotherapy is not clinically indicated. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries. About TALAPRO-3 The Phase 3 TALAPRO-3 trial is a multicenter, randomized, double-blind, placebo-controlled study that enrolled 599 patients with mCSPC (with ≤3 months of ADT [chemical or surgical] with or without an approved ARPI in the mCSPC setting) at sites in the U.S., Canada, Europe, South America, and the Asia-Pacific region. Patients with histologically/cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell, or signet cell features and with alterations in one or more HRR genes (as per HRR12 gene panel) in the trial were randomized to receive TALZENNA 0.5 mg/day plus XTANDI 160mg/day, or placebo plus XTANDI 160mg/day. The primary endpoint of the trial is investigator-assessed rPFS, defined as the time from the date of randomization to radiographic progression in soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or in bone per Prostate Cancer Working Group 3 (PCWG3) criteria by investigator assessment, or death, whichever occurs first. Secondary endpoints include OS, objective response rate, duration of response, and patient-reported outcomes. For more information on the TALAPRO-3 trial (NCT04821622), go to www.clinicaltrials.gov. About TALZENNA® (talazoparib) TALZENNA is an oral inhibitor of poly ADP-ribose polymerase (PARP), which plays a role in DNA damage repair. Preclinical studies have demonstrated that TALZENNA blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to decreased cancer cell growth and cancer cell death. TALZENNA was initially approved in the U.S., EU, and multiple other regions as a single agent for the treatment of adult patients with deleterious or suspected deleterious gBRCAm HER2-negative locally advanced or metastatic breast cancer. TALZENNA in combination with XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with HRR gene-mutated mCRPC in June 2023. The combination was also approved by the European Commission in January 2024 for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. TALZENNA in combination with XTANDI is approved in more than 60 countries, indications vary by country. TALZENNA® (talazoparib) Indication in the U.S. TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: HRR gene-mutated mCRPC: In combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). Breast Cancer: As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. TALZENNA® (talazoparib) Important Safety Information WARNINGS and PRECAUTIONS Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 0.4% (3 out of 788) of solid tumor patients treated with TALZENNA as a single agent in clinical studies. In TALAPRO-2, MDS/AML occurred in 2 out of 511 (0.4%) patients treated with TALZENNA and enzalutamide and in 0 out of 517 (0%) patients treated with placebo and enzalutamide. The durations of TALZENNA treatment in these 5 patients prior to developing MDS/AML were 0.3, 1, 2, 3, and 5 years. Most of these patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy. Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor blood counts monthly during treatment with TALZENNA. For prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If counts do not recover within 4 weeks, refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue TALZENNA. Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia, have been reported in patients treated with TALZENNA. In TALAPRO-2, Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 48%, 19%, and 9% of patients receiving TALZENNA and enzalutamide. Forty-two percent of patients (216/511) required a red blood cell transfusion, including 25% (127/511) who required more than one transfusion. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 8%, 3%, and 0.4% of patients. Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. Monitor blood counts monthly during treatment with TALZENNA. If hematological toxicities do not resolve within 28 days, discontinue TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. Embryo-Fetal Toxicity TALZENNA can cause fetal harm when administered to pregnant women. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 4 months following the last dose of TALZENNA. ADVERSE REACTIONS Serious adverse reactions reported in >2% of patients included anemia (9%) and fracture (3%). Fatal adverse reactions occurred in 1.5% of patients, including pneumonia, COVID infection, and sepsis (1 patient each). The most common adverse reactions (≥ 10%, all Grades), including laboratory abnormalities, for patients in the TALAPRO-2 study who received TALZENNA with enzalutamide vs patients receiving placebo with enzalutamide were hemoglobin decreased (79% vs 34%), neutrophils decreased (60% vs 18%), lymphocytes decreased (58% vs 36%), fatigue (49% vs 40%), platelets decreased (45% vs 8%), calcium decreased (25% vs 11%), nausea (21% vs 17%), decreased appetite (20% vs 14%), sodium decreased (22% vs 20%), phosphate decreased (17% vs 13%), fractures (14% vs 10%), magnesium decreased (14% vs 12%), dizziness (13% vs 9%), bilirubin increased (11% vs 7%), potassium decreased (11% vs 7%), and dysgeusia (10% vs 4.5%). Clinically relevant adverse reactions in 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia. Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm. Drug Interactions Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI. Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI. Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites. Please access this link for XTANDI’S US Full Prescribing Information for additional safety information. About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. About the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize XTANDI® (enzalutamide). The companies jointly commercialize XTANDI in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States. Disclosure Notice The information contained in this release is as of May 30, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology, TALZENNA and XTANDI, including their potential benefits, the TALAPRO-3 results, and plans to discuss the results with global health authorities to potentially expand the TALZENNA indication, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of TALZENNA in combination with XTANDI; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether the TALAPRO-3 trial will meet the key secondary endpoint for overall survival; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications for TALZENNA, XTANDI or a combination may be filed in any jurisdictions for any potential indications; whether and when any such applications for TALZENNA, XTANDI or a combination that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether TALZENNA, XTANDI or a combination will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of TALZENNA, XTANDI or a combination; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. References Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834 American Cancer Society. Key statistics for prostate cancer. Prostate Cancer Facts. Available at: https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html. Last accessed May 2026. Troy SP, Jakubowski CD, Gartrell BA. Packing the punch: Current and emerging treatment strategies in metastatic castration-sensitive prostate cancer. Curr Urol Rep. 2025;26(1):50. doi:10.1007/s11934-025-01272-6 Freedland SJ, Hong A, El-Chaar N, et al. Survival benefit associated with first-line androgen receptor pathway inhibitors for de novo metastatic castration-sensitive prostate cancer. Prostate Cancer Prostatic Dis. 2026;179:167-174. Piombino C, Oltrecolli M, Tonni E, et al. De novo metastatic prostate cancer: Are we moving toward a personalized treatment? Cancers. 2023;15:4945. Olmos D, Lorente D, Jambrina A, et al. BRCA1/2 and homologous recombination repair alterations in high- and low-volume metastatic hormone-sensitive prostate cancer: prevalence and impact on outcomes. Ann Oncol. 2025;36:1190-202. doi:10.1016/j.annonc.2025.05.534 Data on file. Northbrook, IL: Astellas Inc. View source version on businesswire.com: https://www.businesswire.com/news/home/20260530351488/en/ Media Contact:
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IR@Pfizer.com Original: TALZENNA Plus XTANDI Improves Radiographic Progression-Free Survival by More Than 50% in Metastatic Prostate Cancer
US Market News
2週前
Seven-Year Analysis from Pfizer’s LORBRENA CROWN Trial Shows Longest Progression-Free Survival Reported to Date in Advanced Non-Small Cell Lung CancerMay 29, 2026 8:00 AM
Business Wire Patients had a 55% likelihood of remaining alive without disease progression at seven years, and median progression-free survival was not reached with LORBRENA Updated follow-up analysis solidifies LORBRENA as a preferred standard of care, building upon five-year results Pfizer Inc. (NYSE: PFE) today announced unprecedented seven-year follow-up results from the Phase 3 CROWN trial evaluating LORBRENA® (lorlatinib, a third-generation ALK inhibitor, available in Europe under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced or metastatic non-small cell lung cancer (NSCLC). At seven years, patients treated with LORBRENA had a 55% likelihood of remaining alive without disease progression (95% Confidence Interval [CI], 46-63) compared to 3% (95% CI, 1-8) in the XALKORI treatment arm. Further, an updated analysis at seven years of median follow-up showed that investigator-assessed median progression-free survival (PFS) had not been reached with LORBRENA, with an estimated Hazard Ratio (HR) of 0.19 (95% CI, 0.13-0.26), representing an 81% reduction in the risk of disease progression or death compared to XALKORI. Full results from the analysis will be presented today in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8502) and simultaneously published in Annals of Oncology. “The updated results from the CROWN trial show unprecedented long-term clinical benefit, with estimates indicating the majority of patients treated with LORBRENA remained alive and progression-free at seven years. While definitive conclusions cannot be drawn across studies, this appears to represent the longest observed progression-free survival reported to date in metastatic or advanced lung cancer,” said Jeff Legos, Chief Oncology Officer, Pfizer. “These findings further showcase Pfizer’s world-class discovery expertise and our commitment to developing breakthroughs that help improve care for people with advanced NSCLC.” Lung cancer is the leading cause of cancer-related deaths worldwide,1 and nearly 230,000 new cases are expected in the U.S. in 2026.2 NSCLC accounts for approximately 75-80% of lung cancers,2,3 with ALK-positive tumors occurring in about 3-5% of NSCLC cases.4 Approximately 25-40% of people with ALK-positive advanced NSCLC may develop brain metastases within two years from initial diagnosis, which are associated with poorer survival and can profoundly affect cognitive function and quality of life.5 LORBRENA was specifically designed and developed by Pfizer to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood-brain barrier. Results from this seven-year follow-up showed that LORBRENA prevented and controlled brain metastases, with a 94% reduction in the risk of developing intracranial (IC) progression (HR, 0.06; 95% CI, 0.03-0.12) and no new IC progression events occurring after the first 30 months. The median time to IC progression was not reached (95% CI, NR-NR) with LORBRENA and was 16.4 months (12.7-21.9) with XALKORI. At the time of analysis, 44% of patients in the CROWN trial were still receiving LORBRENA compared to 3% of patients receiving XALKORI. “These seven-year outcomes from the CROWN study are remarkable not only for their durability of tumor response but for what they represent—a fundamental shift in what clinicians and patients might reasonably expect from treatment for advanced-stage NSCLC,” said Tony Shu-Kam Mok, BBS, Endowed Professor, Li Shu Fan Medical Foundation, Chairman of the Dept. of Clinical Oncology, Chinese University of Hong Kong, and Principal Investigator of the CROWN trial. “Observing this level of long-term benefit with a once-daily oral therapy, both in terms of sustained progression-free survival and prevention of brain metastases, would have been difficult to imagine when we first developed ALK-specific targeted therapy a decade ago and underscores the significance of these results for the lung cancer community.” “Behind every clinical trial is a person continuing to live their life—raising children, pursuing careers, making memories—without their cancer progressing,” said Kenneth Culver, M.D., Director of Research and Clinical Affairs at the non-profit organization ALK Positive. “These seven-year results provide compelling evidence that long-term disease control is possible, and we applaud Pfizer's dedication to advancing treatments that are changing what it means to live with ALK-positive lung cancer.” The safety profiles of LORBRENA and XALKORI were consistent with previous findings, with no new safety signals observed. In this analysis, the most frequent (≥20%) adverse events (AEs) of interest reported in patients treated with LORBRENA included edema, weight gain, peripheral neuropathy, cognitive effects, mood effects, diarrhea, dyspnea, arthralgia, hypertension, headache, cough, pyrexia, hypercholesterolemia, and hypertriglyceridemia. All-cause grade 3/4 AEs occurred in 77% of patients with LORBRENA and in 57% of patients with XALKORI. Treatment-related AEs led to permanent treatment discontinuation in 5% and 6% of patients in the LORBRENA and XALKORI arms, respectively. No new permanent discontinuations due to treatment-related AEs occurred after the first 26 months with LORBRENA. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries. About the CROWN Trial CROWN is a Phase 3, randomized, open-label, parallel two-arm trial in which 296 people with previously untreated ALK-positive advanced NSCLC were randomized 1:1 to receive LORBRENA monotherapy (n=149) or XALKORI monotherapy (n=147). The primary endpoint of the CROWN trial was PFS based on Blinded Independent Central Review (BICR) with a key secondary endpoint of overall survival (OS) for which follow-up is ongoing and results will be reported in the future. Additional secondary endpoints include PFS based on investigator’s assessment, objective response rate (ORR), intracranial objective response rate (IC-ORR), and safety. Given that median PFS was not reached after three years of follow-up, and then later after five years of follow-up, unplanned post-hoc analyses were executed with the intent to further quantify long-term outcomes based on investigator tumor assessment from this trial. The present analysis was performed at a clinically meaningful landmark follow-up of seven years. About LORBRENA® (lorlatinib) LORBRENA is approved in the U.S. for the treatment of adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. In addition to the U.S., LORBRENA has received approval in more than 80 countries, including Australia, Canada, China, European Union, Japan, and South Korea. Please see Full Prescribing Information for LORBRENA® (lorlatinib) or visit https://www.lorbrena.com. IMPORTANT LORBRENA® (lorlatinib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION Contraindications: LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity. Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers: Severe hepatotoxicity occurred in 10 of 12 healthy subjects receiving a single dose of LORBRENA with multiple daily doses of rifampin, a strong CYP3A inducer. Grade 4 ALT or AST elevations occurred in 50% of subjects, Grade 3 in 33% of subjects, and Grade 2 in 8% of subjects. ALT or AST elevations occurred within 3 days and returned to within normal limits after a median of 15 days (7 to 34 days); median time to recovery in subjects with Grade 3 or 4 or Grade 2 ALT or AST elevations was 18 days and 7 days, respectively. LORBRENA is contraindicated in patients taking strong CYP3A inducers. Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA. Central Nervous System (CNS) Effects: A broad spectrum of CNS effects can occur; overall, CNS effects occurred in 52% of the 476 patients receiving LORBRENA. These included seizures (1.9%, sometimes in conjunction with other neurologic findings), psychotic effects (7%; 0.6% severe [Grade 3 or 4]), and changes in cognitive function (28%; 2.9% severe), mood (including suicidal ideation) (21%; 1.7% severe), speech (11%; 0.6% severe), mental status (1.3%; 1.1% severe), and sleep (12%). Median time to first onset of any CNS effect was 1.4 months (1 day to 3.4 years). Overall, 2.1% and 10% of patients required permanent or temporary discontinuation of LORBRENA, respectively, for a CNS effect; 8% required dose reduction. Withhold and resume at same or reduced dose or permanently discontinue based on severity. Hyperlipidemia: Increases in serum cholesterol and triglycerides can occur. Grade 3 or 4 elevations in total cholesterol occurred in 18% and Grade 3 or 4 elevations in triglycerides occurred in 19% of the 476 patients who received LORBRENA. Median time to onset was 15 days for both hypercholesterolemia and hypertriglyceridemia. Approximately 4% and 7% of patients required temporary discontinuation and 1% and 3% of patients required dose reduction of LORBRENA for elevations in cholesterol and in triglycerides in Study B7461001 and Study B7461006, respectively. Eighty-three percent of patients required initiation of lipid-lowering medications, with a median time to onset of start of such medications of 17 days. Initiate or increase the dose of lipid-lowering agents in patients with hyperlipidemia. Monitor serum cholesterol and triglycerides before initiating LORBRENA, 1 and 2 months after initiating LORBRENA, and periodically thereafter. Withhold and resume at same dose for the first occurrence; resume at same or reduced dose of LORBRENA for recurrence based on severity. Atrioventricular (AV) Block: PR interval prolongation and AV block can occur. In 476 patients who received LORBRENA at a dose of 100 mg orally once daily and who had a baseline electrocardiography (ECG), 1.9% experienced AV block and 0.2% experienced Grade 3 AV block and underwent pacemaker placement. Monitor ECG prior to initiating LORBRENA and periodically thereafter. Withhold and resume at reduced or same dose in patients who undergo pacemaker placement. Permanently discontinue for recurrence in patients without a pacemaker. Interstitial Lung Disease (ILD)/Pneumonitis: Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis can occur. ILD/pneumonitis occurred in 1.9% of patients, including Grade 3 or 4 ILD/pneumonitis in 0.6% of patients. Four patients (0.8%) discontinued LORBRENA for ILD/pneumonitis. Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, and fever). Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENA for treatment related ILD/pneumonitis of any severity. Hypertension: Hypertension can occur. Hypertension occurred in 13% of patients, including Grade 3 or 4 in 6% of patients. Median time to onset of hypertension was 6.4 months (1 day to 2.8 years), and 2.3% of patients temporarily discontinued LORBRENA for hypertension. Control blood pressure prior to initiating LORBRENA. Monitor blood pressure after 2 weeks and at least monthly thereafter. Withhold and resume at reduced dose or permanently discontinue based on severity. Hyperglycemia: Hyperglycemia can occur. Hyperglycemia occurred in 9% of patients, including Grade 3 or 4 in 3.2% of patients. Median time to onset of hyperglycemia was 4.8 months (1 day to 2.9 years), and 0.8% of patients temporarily discontinued LORBRENA for hyperglycemia. Assess fasting serum glucose prior to initiating LORBRENA and monitor periodically thereafter. Withhold and resume at reduced dose or permanently discontinue based on severity. Embryo-fetal Toxicity: LORBRENA can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective non-hormonal method of contraception, since LORBRENA can render hormonal contraceptives ineffective, during treatment with LORBRENA and for at least 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with LORBRENA and for 3 months after the final dose. Adverse Reactions: In the pooled safety population of 476 patients who received 100 mg LORBRENA once daily, the most frequent (≥ 20%) adverse reactions were edema (56%), peripheral neuropathy (44%), weight gain (31%), cognitive effects (28%), fatigue (27%), dyspnea (27%), arthralgia (24%), diarrhea (23%), mood effects (21%), and cough (21%). The most frequent (≥ 20%) Grade 3-4 laboratory abnormalities in patients receiving LORBRENA were hypercholesterolemia (21%) and hypertriglyceridemia (21%). In previously untreated patients, serious adverse reactions occurred in 34% of the 149 patients treated with LORBRENA; the most frequently reported serious adverse reactions were pneumonia (4.7%), dyspnea (2.7%), respiratory failure (2.7%), cognitive effects (2.0%), and pyrexia (2.0%). Fatal adverse reactions occurred in 3.4% of patients and included pneumonia (0.7%), respiratory failure (0.7%), cardiac failure acute (0.7%), pulmonary embolism (0.7%), and sudden death (0.7%). In the Phase 1/2 study, serious adverse reactions occurred in 32% of the 295 patients; the most frequently reported serious adverse reactions were pneumonia (3.4%), dyspnea (2.7%), pyrexia (2%), mental status changes (1.4%), and respiratory failure (1.4%). Fatal adverse reactions occurred in 2.7% of patients and included pneumonia (0.7%), myocardial infarction (0.7%), acute pulmonary edema (0.3%), embolism (0.3%), peripheral artery occlusion (0.3%), and respiratory distress (0.3%). Drug Interactions: LORBRENA is contraindicated in patients taking strong CYP3A inducers. Avoid concomitant use with moderate CYP3A inducers, strong CYP3A inhibitors, and fluconazole. If concomitant use of moderate CYP3A inducers cannot be avoided, increase the LORBRENA dose as recommended. If concomitant use with a strong CYP3A inhibitor or fluconazole cannot be avoided, reduce the LORBRENA dose as recommended. Avoid concomitant use of LORBRENA with CYP3A substrates and P-gp substrates, which may reduce the efficacy of these substrates. Lactation: Because of the potential for serious adverse reactions in breastfed infants, instruct women not to breastfeed during treatment with LORBRENA and for 7 days after the final dose. Hepatic Impairment: No dose adjustment is recommended for patients with mild (total bilirubin ≤ ULN with AST > ULN or total bilirubin >1 to 1.5 × ULN with any AST) to moderate (Child-Pugh B) hepatic impairment. In patients with severe hepatic impairment (Child-Pugh C), the recommended dosage of LORBRENA is 50 mg orally once daily. Renal Impairment: In patients with CLcr 15 to 3 times ULN with concurrent total bilirubin elevation >1.5 times ULN (in the absence of cholestasis or hemolysis); otherwise, temporarily suspend and dose-reduce XALKORI as indicated. Interstitial Lung Disease/Pneumonitis: Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur. Across clinical trials (n=1719), 2.9% of XALKORI-treated patients had any grade ILD, 1.0% had Grade 3/4, and 0.5% had fatal ILD. ILD generally occurred within 3 months after initiation of treatment. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Exclude other potential causes and permanently discontinue XALKORI in patients with drug-related ILD/pneumonitis. QT Interval Prolongation: QTc prolongation can occur. Across clinical trials (n=1616), 2.1% of patients had QTcF (corrected QT by the Fridericia method) ≥500 ms and 5% of 1582 patients had an increase from baseline QTcF ≥60 ms by automated machine-read evaluation of ECGs. Avoid use in patients with congenital long QT syndrome. Monitor ECGs and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or who are taking medications that prolong the QT interval. Permanently discontinue XALKORI in patients who develop QTc >500 ms or ≥60 ms change from baseline with Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia. Withhold XALKORI in patients who develop QTc >500 ms on at least 2 separate ECGs until recovery to a QTc ≤480 ms, then resume at next lower dosage. Bradycardia: Symptomatic bradycardia can occur. Across clinical trials, bradycardia occurred in 13% of patients treated with XALKORI (n=1719). Avoid use in combination with other medications known to cause bradycardia. Monitor heart rate and blood pressure regularly. If bradycardia occurs, re-evaluate for the use of concomitant medications known to cause bradycardia. Permanently discontinue for life-threatening bradycardia due to XALKORI; however, if associated with concomitant medications known to cause bradycardia or hypotension, hold XALKORI until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If concomitant medications can be adjusted or discontinued, restart XALKORI at 250 mg once daily with frequent monitoring. Severe Visual Loss: Across clinical trials, the incidence of Grade 4 visual field defect with vision loss was 0.2% of 1719 patients. Discontinue XALKORI in patients with new onset of severe visual loss (best corrected vision less than 20/200 in one or both eyes). Perform an ophthalmological evaluation. There is insufficient information to characterize the risks of resumption of XALKORI in patients with a severe visual loss; a decision to resume should consider the potential benefits to the patient. Vision Disorders: Most commonly visual impairment, photopsia, blurred vision or vitreous floaters, occurred in 63% of 1719 patients. The majority (95%) of these patients had Grade 1 visual adverse reactions. 0.8% of patients had Grade 3 and 0.2% had Grade 4 visual impairment. The majority of patients on the XALKORI arms in Studies 1 and 2 (>50%) reported visual disturbances which occurred at a frequency of 4-7 days each week, lasted up to 1 minute, and had mild or no impact on daily activities. Embryo-Fetal Toxicity: XALKORI can cause fetal harm when administered to a pregnant woman. Advise of the potential risk to the fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 45 days (females) or 90 days (males) respectively, following the final dose of XALKORI. ROS1-positive Metastatic NSCLC: Safety was evaluated in 50 patients with ROS1-positive metastatic NSCLC from a single-arm study and was generally consistent with the safety profile of XALKORI evaluated in patients with ALK-positive metastatic NSCLC. Vision disorders occurred in 92% of patients in the ROS1 study; 90% of patients had Grade 1 vision disorders and 2% had Grade 2. Adverse Reactions: Safety was evaluated in a phase 3 study in previously untreated patients with ALK-positive metastatic NSCLC randomized to XALKORI (n=171) or chemotherapy (n=169). Serious adverse events were reported in 34% of patients treated with XALKORI, the most frequent were dyspnea (4.1%) and pulmonary embolism (2.9%). Fatal adverse events in XALKORI-treated patients occurred in 2.3% of patients, consisting of septic shock, acute respiratory failure, and diabetic ketoacidosis. Common adverse reactions (all grades) occurring in ≥25% and more commonly (≥5%) in patients treated with XALKORI vs chemotherapy were vision disorder (71% vs 10%), diarrhea (61% vs 13%), edema (49% vs 12%), vomiting (46% vs 36%), constipation (43% vs 30%), upper respiratory infection (32% vs 12%), dysgeusia (26% vs 5%), and abdominal pain (26% vs 12%). Grade 3/4 reactions occurring at a ≥2% higher incidence with XALKORI vs chemotherapy were QT prolongation (2% vs 0%), esophagitis (2% vs 0%), and constipation (2% vs 0%). In patients treated with XALKORI vs chemotherapy, the following occurred: elevation of ALT (any grade [79% vs 33%] or Grade 3/4 [15% vs 2%]); elevation of AST (any grade [66% vs 28%] or Grade 3/4 [8% vs 1%]); neutropenia (any grade [52% vs 59%] or Grade 3/4 [11% vs 16%]); lymphopenia (any grade [48% vs 53%] or Grade 3/4 [7% vs 13%]); hypophosphatemia (any grade [32% vs 21%] or Grade 3/4 [10% vs 6%]). In patients treated with XALKORI vs chemotherapy, renal cysts occurred (5% vs 1%). Nausea (56%), decreased appetite (30%), fatigue (29%), and neuropathy (21%) also occurred in patients taking XALKORI. Drug Interactions: Use caution with concomitant use of moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice which may increase plasma concentrations of crizotinib. Avoid concomitant use of strong CYP3A inducers and inhibitors. Avoid concomitant use of CYP3A substrates where minimal concentration changes may lead to serious adverse reactions. If concomitant use of XALKORI is unavoidable, decrease the CYP3A substrate dosage in accordance with approved product labeling. Lactation: Because of the potential for adverse reactions in breastfed children, advise women not to breastfeed during treatment with XALKORI and for 45 days after the final dose. Hepatic Impairment: Crizotinib concentrations increased in patients with pre-existing moderate (any AST and total bilirubin >1.5x ULN and ≤3x ULN) or severe (any AST and total bilirubin >3x ULN) hepatic impairment. Reduce XALKORI dosage in patients with moderate or severe hepatic impairment. The recommended dose of XALKORI in patients with pre-existing moderate hepatic impairment is 200 mg orally twice daily or with pre-existing severe hepatic impairment is 250 mg orally once daily. Renal Impairment: Decreases in estimated glomerular filtration rate occurred in patients treated with XALKORI. Administer XALKORI at a starting dose of 250 mg taken orally once daily in patients with severe renal impairment (CLcr
US Market News
2週前
Pfizer and Innovent Biologics Enter Global Strategic Collaboration to Accelerate Development of Innovative Oncology MedicinesMay 28, 2026 7:00 PM
Business Wire Pfizer Inc. (NYSE: PFE) and Innovent Biologics, Inc. (01801.HK), today announced the companies have entered into a strategic global licensing and collaboration agreement for the research and development of 12 promising new breakthrough early-stage and de novo cancer medicines. The partnership includes licensing, co-development, and co-commercialization opportunities across a diverse portfolio of antibody-drug conjugates (ADCs) with novel differentiated payloads and multi-specific antibodies with differentiated immune-engaging features and unique designs. The strategic collaboration brings together Pfizer’s deep scientific expertise, global clinical development capabilities, regulatory leadership and commercial scale with Innovent’s scientific discovery and clinical capabilities in oncology innovation, which are highly complementary to each company’s core areas of interest. The agreement spans a portfolio of 12 programs comprising eight Innovent-originated early-stage programs and four Pfizer-proposed discovery programs. The companies will co-develop and share costs for select programs as they advance these programs through clinical development. “At Pfizer, everything we do starts with patients and the urgency to change what’s possible for people living with cancer,” said Jeff Legos, Chief Oncology Officer, Pfizer. “This collaboration brings together two highly complementary engines of innovation with a shared ambition to move faster, go further and deliver truly transformative medicines to patients who are waiting. By combining Innovent’s discovery and early clinical development with Pfizer’s global research and development and commercialization capabilities, we have an opportunity not only to strengthen our pipeline, but to accelerate the delivery of breakthroughs that can redefine standards of care and make a meaningful difference in patients’ lives.” “This agreement brings together best-in-industry expertise of Pfizer and Innovent to advance novel cancer medicines to patients at a global scale,” said Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent. “By leveraging both companies' complementary resources, we can develop our early-stage oncology pipeline with greater speed and impact to help bring innovative therapies to patients more efficiently worldwide. Furthermore, co-developing and co-commercializing key projects in the U.S. and Europe expands Innovent’s global reach. At Innovent, we are laying the foundation for a truly global oncology platform that can deliver meaningful and lasting benefits for patients around the world.” According to the agreement, Innovent will conduct development of these programs through Phase 1, powered by its proprietary discovery engine and robust early clinical capabilities, after which Pfizer will lead future global development. The agreement also sets out the following licensing and commercialization structure: Pfizer will receive an exclusive global license for four programs, and will be responsible for the global development costs; Pfizer will receive an exclusive license outside Greater China for four programs, and will be responsible for the majority of the development costs; and Pfizer and Innovent will co-develop four programs globally and share the development costs. The companies will co-commercialize in the United States and Europe*, and share the profits. Innovent will retain Greater China rights to these programs. Under the financial terms of the agreement, Innovent will receive a $650 million upfront payment and is eligible for up to $9.85 billion in development, regulatory and commercial milestone payments. Additionally, Innovent will receive up to double-digit royalties on sales of each licensed product if approved. For the ‘co-developed, co-commercialized’ programs, the two companies will share the profits in the U.S. and Europe. The transaction is expected to close in the third quarter subject to fulfillment of required regulatory approvals. * Europe refers to the European Union and the United Kingdom About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific immune-engaging antibodies. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematologic malignancies, and thoracic cancers, such as lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For over 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 5 assets in Phase III or pivotal clinical trials and 14 more molecules in early clinical stage. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug(s)/indication(s). Forward-looking statement of Innovent Biologics This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. Pfizer Disclosure Notice The information contained in this release is as of May 28, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology and a strategic global licensing and collaboration agreement between Pfizer and Innovent Biologics, Inc. for the research and development of 12 early-stage and de novo cancer medicine programs, including their potential benefits and the anticipated timing of closing of the transaction, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks related to the satisfaction or waiver of the conditions to closing the proposed transaction (including the failure to obtain required regulatory approvals) in the anticipated timeframe or at all, including the possibility that the proposed transaction does not close; risks related to the ability to realize the anticipated benefits of the licensing and collaborations agreement, including the possibility that the expected benefits will not be realized or will not be realized within the expected time period; risks related to the successful integration of the licensed assets with Pfizer’s business; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of this announcement or the consummation of the proposed transaction on the market price of Pfizer’s common stock and/or operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to proposed transaction or the programs; manufacturing capabilities or capacity; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; future exchange and interest rates; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy; changes in tax and other laws, regulations, rates and policies; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer’s business and prospects, adverse developments in Pfizer’s markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment, tariffs and other trade policies or economies generally; future business combinations or disposals; uncertainties regarding the commercial success of the programs and Pfizer’s commercialized and pipeline products; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications may be filed in any jurisdictions for any drug candidates for any potential indications; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such candidate medicines will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any such drug candidate; whether our collaboration with Innovent will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. Category: Corporate, Research and Pipeline View source version on businesswire.com: https://www.businesswire.com/news/home/20260527822150/en/ Pfizer Contacts:
Media: PfizerMediaRelations@Pfizer.com
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US Market News
3週前
Pfizer Advances Pivotal Pediatric Pneumococcal Vaccine Program Following Strong Positive Phase 2 ResultsMay 20, 2026 5:05 AM
Business Wire Phase 2 data demonstrate robust immunogenicity, including enhanced response against serotype 3, alongside expanded protection across 25 serotypes; to achieve potential vaccine serotype coverage of 90% in the pediatric population An oral presentation at ISPPD highlighted an approximately 9 to 15-fold higher serotype 3 immunogenicity response after Dose 3 and 4 in infants receiving Pfizer’s 25-valent vaccine candidate (25vPnC) compared to PREVNAR 20® The investigational vaccine candidate was well-tolerated with no safety concerns identified in a Phase 2 study Based on these encouraging results from the Phase 2 program across serotypes and discussions with regulatory authorities, Pfizer initiated its Phase 3 25vPnC pediatric program Company advances adult program to fifth generation 35-valent vaccine candidate Pfizer Inc. (NYSE: PFE) today announced data from its Phase 2 study (NCT06524414) evaluating the safety, tolerability and immunogenicity of a four-dose series of its investigational 25-valent pneumococcal conjugate vaccine candidate PF-07872412 (25vPnC) in infants compared to four doses of PREVNAR 20 at months 2, 4, 6 and 12-15. Based on the strong immune responses observed for all 25vPnC serotypes from Phase 2, compared to PREVNAR 20, Pfizer is confident that the required non-inferiority thresholds may be achieved for the 25vPnG pediatric Phase 3 program. Key preliminary data from the broader Phase 2 study were presented today in an oral presentation at the 14th meeting of the International Society of Pneumonia & Pneumococcal Diseases in Copenhagen, Denmark (ISPPD). Results found: One month after Dose 3, geometric mean titers for serotype 3 were 8.8-fold higher with 25vPnC than with PREVNAR 20 (4.22 vs. 0.48). One month after Dose 4, geometric mean titers for serotype 3 were approximately 15-fold higher with 25vPnC than with Prevnar 20 (13.85 vs. 0.92). This vaccine candidate is expected to cover up to 90% of disease-causing serotypes in children under 5 years of age, which includes approximately 15% from serotype 3. “For more than 25 years, our vaccines have helped protect children from pneumococcal disease, yet significant disease burden remains,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer. “These Phase 2 results reinforce our confidence in a next-generation vaccine designed to expand protection across serotypes while improving responses to key residual disease drivers such as serotype 3. We are advancing our Phase 3 program with the goal of delivering broader and more durable protection for children.” The Phase 2 study is a randomized trial in healthy infants, with initial enrolment beginning in July 2024, evaluating 25vPnC compared with PREVNAR 20. Participants were randomized to receive 25vPnC or PREVNAR 20 at months 2, 4, 6 and 12–15 assessing the safety and tolerability, including local and systemic reactogenicity within seven days after each vaccination, as well as adverse events and serious adverse events in participants who receive at least one dose. The trial also assessed immunogenicity one month after Dose 3 and one month after Dose 4, compared to one month after Dose 3 and Dose 4 with PREVNAR 20. The safety and tolerability profile of 25vPnC was consistent with the currently approved and available pneumococcal vaccine. The most common local reactions were redness, swelling or pain at injection site similar to existing vaccines. Advancing Pediatric and Adult into Pivotal Phase 3 Studies Despite significant reduction in pneumococcal disease burden by the currently available 20-valent standard-of-care-vaccine, serotype 3 remains a notable cause of invasive pneumococcal disease and complicated pneumonia in children. Therefore, based on this Phase 2 data and discussions with regulatory authorities, Pfizer began a pivotal pediatric Phase 3 program in May 2026. The studies evaluate safety, tolerability and immunogenicity of 25vPnC in healthy children where participants receive either 25vPnC or PCV20 at 2, 4, 6 and 12 to 15 months of age. Participants will receive the same vaccine for all four vaccinations for up to 2,400 individuals comparing 25vPnC to the currently licensed 20-valent standard-of-care vaccine. The vaccine candidate covers 25 serotypes including serotype 3, adding five new serotypes to the established vaccine coverage for infants. If successful, this has the potential to broaden protection to about 90% of disease-causing serotypes in US children. Meanwhile, as the strongest opportunity to maintain the company’s current leadership in the adult market over the long term, Pfizer has decided to move directly to a fifth-generation vaccine candidate covering 35 serotypes. This fifth-generation adult candidate has the potential to increase serotype coverage while also improving immunogenicity for critical serotypes including serotype 3 with Pfizer’s proprietary next generation technology. The adult vaccine candidate is expected to enter clinical development by the end of 2026, pending alignment with regulatory authorities. About 25vPnC (25-valent pneumococcal conjugate vaccine candidate) Pfizer's 4th-generation pneumococcal conjugate vaccine candidate builds on the 20 serotypes already covered by PCV20 (PREVNAR 20). It adds five additional serotypes — 15A, 23A, 23B, 24F, and 35B that represents additional 25% coverage of IPD cases compared with PCV20 to broaden coverage to 25 serotypes total, including cross-reactivity. Beyond expanding serotype coverage, 25vPnC also aims to enhance protection against serotype 3, which remains a key driver of residual pneumococcal disease. To achieve this, 25vPnC utilizes next-generation technology specifically designed to elicit a more robust immune response against serotype 3. U.S. INDICATION AND IMPORTANT SAFETY INFORMATION FOR PREVNAR 20 INDICATION PREVNAR 20 is a vaccine approved for: the prevention of invasive disease caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks of age and older. the prevention of otitis media (middle ear infection) caused by 7 of the 20 strains in individuals 6 weeks through 5 years. active immunization for the prevention of pneumonia caused by Streptococcus pneumoniae strains 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older. The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved based on immune responses. Continued approval may depend on a supportive study. IMPORTANT SAFETY INFORMATION PREVNAR 20 should not be given to anyone who has had a severe allergic reaction to any component of Prevnar 20 or to diphtheria toxoid. Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups. A temporary pause in breathing after getting a vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your healthcare provider about the infant's medical status when deciding to get vaccinated with Prevnar 20. In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever. In individuals 15 months through 17 years of age vaccinated with a single dose, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, fatigue, muscle pain, decreased appetite, injection site swelling, injection site redness, headache, and fever. In individuals 18 years and older, the most common side effects reported at a rate of >10% were pain at the injection site, muscle pain, fatigue, headache, and joint pain. Also, injection site swelling was common in individuals 18 years through 59 years of age. Ask your healthcare provider about the risks and benefits of Prevnar 20. Only a healthcare provider can decide if PREVNAR 20 is right for you or your child. Please click for PREVNAR 20 Full Prescribing Information. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Disclosure Notice The information contained in this release is as of May 20, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about an investigational pediatric 25-valent pneumococcal conjugate vaccine candidate PF-07872412 (25vPnC) and an investigational adult fifth-generation vaccine candidate covering 35 serotypes (35vPnC), including their potential benefits, results from a Phase 2 study of 25vPvC in infants and clinical development plans and timing for 25vPnC and 35vPnC, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications may be filed in any jurisdictions for 25vPnC or 35vPnC; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether 25vPnC and 35vPnC will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of 25vPnC and 35vPnC; uncertainties regarding the ability to obtain or maintain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; risks and uncertainties related to changes to vaccine or other healthcare policy in the U.S.; challenges related to public vaccine confidence or awareness; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. Category: Research and Pipeline View source version on businesswire.com: https://www.businesswire.com/news/home/20260520512448/en/ Pfizer Media Contact:
PfizerMediaRelations@Pfizer.com Pfizer Investor Relations:
IR@pfizer.com Original: Pfizer Advances Pivotal Pediatric Pneumococcal Vaccine Program Following Strong Positive Phase 2 Results
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