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Genmab Announces Epcoritamab Monotherapy and Epcoritamab-Based Combination Regimens Demonstrate High Response Rates in Elderly Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)June 13, 2026 12:45 PM
Business Wire Results from the Phase 2 EPCORE® DLBCL-3 trial show fixed-duration epcoritamab monotherapy demonstrated early responses in elderly patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) ineligible for anthracycline-based chemotherapy Results from the Phase 1b/2 EPCORE® NHL-2 trial show fixed-duration epcoritamab plus standard of care R-mini-CHOP demonstrated sustained minimal residual disease (MRD) negativity and durable remissions in elderly patients with newly diagnosed DLBCL ineligible for full dose R-CHOP Data were presented at the 2026 European Hematology Association (EHA) Congress Genmab A/S (Nasdaq: GMAB) today announced new data from two studies evaluating epcoritamab, a T-cell engaging antibody administered subcutaneously, in the first-line (1L) treatment of patients with diffuse large B-cell lymphoma (DLBCL) who may have limited treatment options due to advanced age or multiple health conditions. Results from the Phase 2 EPCORE® DLBCL-3 study showed an overall response rate (ORR) of 67% and a complete response (CR) rate of 58% with epcoritamab monotherapy in elderly patients with newly diagnosed DLBCL. In the Phase 1b/2 EPCORE NHL-2 study, epcoritamab plus rituximab plus dose-attenuated cyclophosphamide, doxorubicin, vincristine, and prednisone (R-mini-CHOP) demonstrated an ORR of 93% and a CR rate of 86% in elderly patients with newly diagnosed DLBCL. The results from both studies were presented in two poster presentations (abstracts PS2082 and PF1007) at the European Hematology Association (EHA) 2026 Congress held in Stockholm, Sweden, June 11-14. Additionally, the full EPCORE DLBCL-3 results have been simultaneously published in The Lancet Haematology. EPCORE DLBCL-3 Results
The Phase 2 EPCORE DLBCL-3 study (abstract PS2082) evaluated the efficacy and safety of fixed-duration epcoritamab monotherapy in newly diagnosed CD20+ large B-cell lymphoma (LBCL) patients ineligible for anthracycline-based chemotherapy due to age (≥80 years) or comorbidities (≥75 years with comorbidities). Among 66 enrolled patients, the median age was 82.5 years, and all had comorbid conditions (94% with ≥3 comorbidities). With a median follow-up of 21.9 months, epcoritamab monotherapy demonstrated responses in this population with high unmet medical need. An ORR of 67% and a CR rate of 58% were observed in evaluable patients (n=66). Median time to response was 1.5 months, and median time to CR was 2.2 months. Notably, 11 of 17 patients with a partial response or stable disease at first assessment subsequently achieved a CR. "For newly diagnosed elderly patients with diffuse large B-cell lymphoma and comorbidities, who are often excluded from standard curative chemotherapy and ineligible for doxorubicin, finding more options is paramount," said Umberto Vitolo, M.D. Candiolo Cancer Institute, FPO-IRCCS, Candiolo (Turin), Italy. "The EPCORE DLBCL-3 study showed that epcoritamab monotherapy offers robust data. Importantly, its safety profile, including cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome, was consistent with expected rates in this fragile population with a high unmet medical need for new therapeutic options." Responses were durable, with median duration of response (DOR) and duration of complete response (DOCR) not reached. At 12 months, an estimated 67% of responses and 73% of CRs remained ongoing. Median progression-free survival (PFS) was 13.0 months, while median overall survival (OS) was not reached; an estimated 43% of patients remained progression-free and 62% were alive at 18 months. High rates of minimal residual disease (MRD) negativity were observed, with 92% of evaluable responders achieving MRD negativity, typically by Cycle 3 Day 1 and sustained through Cycle 12 Day 1 in most patients. The safety profile was consistent with expected rates in this elderly population. Cytokine release syndrome (CRS) occurred in 71% of patients, most commonly during Cycle 1, and immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 18%. Infections of any grade occurred in 68% of patients (26% Grade ≥3), and neutropenia was reported in 16%, with no febrile neutropenia or clinical tumor lysis syndrome observed. Eight Grade 5 TEAEs occurred. EPCORE NHL-2, Arm 8 Results
Arm 8 of the Phase 1b/2 EPCORE NHL-2 study (abstract PF1007) evaluated epcoritamab plus R-mini-CHOP in 28 newly diagnosed CD20+ DLBCL patients ineligible for full-dose R-CHOP due to age (≥75 years) or comorbidities (≥65 years with comorbidities). With more than two years of follow-up, fixed-duration epcoritamab plus R-mini-CHOP demonstrated high response rates, sustained MRD negativity and durable remissions. An ORR of 93% and a CR rate of 86% were observed. Median DOR, DOCR, PFS, and OS were not reached. At two years, estimated DOR and DOCR rates were 79%, while estimated PFS and OS rates were 76% and 82%, respectively. “The EPCORE NHL-2 Arm 8 results are very encouraging, showing that combining epcoritamab with R-mini-CHOP led to high overall response rates and complete response rates, rapid and sustained minimal residual disease negativity, and durable remissions in this population,” said David Belada, M.D., Department of Internal Medicine—Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic. “These outcomes, alongside a consistent safety profile, potentially support the integration of epcoritamab with standard of care for these vulnerable patients, and highlight its broad utility in combinations across a range of disease settings and patient populations." Rapid and sustained MRD negativity was observed, with 95% of evaluable patients achieving MRD negativity, including high rates in high-risk subgroups. Outcomes compared favorably with historical results for R-mini-CHOP alone. The safety profile was consistent with prior reports and the known safety profiles of epcoritamab and R-mini-CHOP. The most common Grade ≥3 treatment-emergent adverse events (TEAEs) were neutropenia (54%), serious infections (33%) and anemia (14%). Most Grade ≥3 serious infections occurred during the first six cycles of treatment with R-mini-CHOP coadministration. TEAEs led to epcoritamab discontinuation in three patients (11%). “Genmab is committed to evaluating epcoritamab as a potential treatment option in earlier lines of therapy for patients who traditionally struggle with aggressive treatment," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "The robust data observed in both the monotherapy and combination approaches reinforce our vision of making epcoritamab a foundational therapy across the spectrum of B-cell malignancies. These Phase 2 results support our ongoing commitment to addressing the significant unmet medical needs of elderly and comorbid patients, as we seek to identify effective, less intensive and tolerable options." About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) DLBCL is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.i,ii DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.iii,iv DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.iv,v About the EPCORE® DLBCL-3 Trial
EPCORE DLBCL-3 (NCT05660967) is an open-label, randomized, global, Phase 2 trial to evaluate the efficacy and safety of epcoritamab as monotherapy or in combination with lenalidomide as first-line therapy for anthracycline-ineligible subjects with diffuse large B-cell lymphoma (DLBCL). This is a 2-stage trial. In Stage 1, eligible patients were randomized to either epcoritamab monotherapy or epcoritamab plus lenalidomide. In Stage 2, additional patients were enrolled to the epcoritamab monotherapy arm. Each treatment cycle is 28 days. Patients will receive a maximum of 12 cycles (up to 1 year) of treatment. The primary objective is to evaluate the clinical efficacy of epcoritamab monotherapy or epcoritamab and lenalidomide. The primary endpoint is to achieve a complete response rate determined by Lugano criteria. Additional secondary endpoints include overall response rate, duration of response, duration of complete response, rate of minimal residual disease negativity, progression-free survival and overall survival. More information on this trial can be found at www.clinicaltrials.gov/. About the EPCORE® NHL-2 Trial
EPCORE NHL-2 (NCT04663347) is a Phase 1b/2 open-label interventional trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab as a monotherapy and in combination with other standard of care agents in patients with B-cell non-Hodgkin lymphoma (B-NHL). The trial consists of two parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The primary objective of Part 1 is safety, and the primary goal of Part 2 is preliminary efficacy. The primary efficacy endpoint is overall response rate (ORR) based on best overall response per Lugano criteria. MRD negativity was assessed as a secondary endpoint. More information on this trial can be found at www.clinicaltrials.gov. About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vi Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in more than 65 territories. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (DLBCL) indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. What is EPKINLY?
EPKINLY is a prescription medicine used to treat adults with: certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory) after 2 or more treatments. follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab follicular lymphoma (FL) that has come back or that did not respond after 2 or more treatments. EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children. IMPORTANT SAFETY INFORMATION
Important Warnings—EPKINLY can cause serious side effects, including: Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Neurologic problems that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. People with DLBCL or high-grade B-cell lymphoma may be hospitalized after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems. People with FL may be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion. Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets. The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include rash, upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab include decreased white blood cells and decreased platelets. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Medication Guide, including Important Warnings. About Genmab
Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd. ____________________ i Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma. Accessed February 2026. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/ ii Padala, et al. Diffuse Large B-Cell Lymphoma. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. 2023 Apr 24. iii Sehn, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384:842-858. doi: 10.1056/NEJMra2027612. iv Kanas, et al. Epidemiology of Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) in the United States and Western Europe: Population-Level Projections for 2020-2025. Leuk Lymphoma. 2022;63(1):54-63. doi: 10.1080/10428194.2021.1975188. v Crump, et al. Outcomes in Refractory Diffuse Large B-Cell Lymphoma: Results From the International SCHOLAR-1 Study. Blood. 2017;130(16):1800-1808. doi: 10.1182/blood-2017-03-769620. vi Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625.   View source version on businesswire.com: https://www.businesswire.com/news/home/20260610278575/en/ David Freundel, Senior Director, Global Communications & Corporate Affairs
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T: +45 3377 9558; E: acn@genmab.com Original: Genmab Announces Epcoritamab Monotherapy and Epcoritamab-Based Combination Regimens Demonstrate High Response Rates in Elderly Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Genmab Presents EPCORE® FL-1 Subgroup Data Demonstrating Consistent Efficacy and Safety Results for Epcoritamab in Combination with Rituximab and Lenalidomide (R2) Across Relapsed or Refractory (R/R) Follicular Lymphoma (FL) PatientsJune 11, 2026 10:45 AM
Business Wire Findings from a post-hoc subgroup analysis of the Phase 3 EPCORE® FL-1 trial reinforce fixed-duration epcoritamab in combination with rituximab and lenalidomide (R2 ) data across subgroups in this trial of relapsed or refractory (R/R) follicular lymphoma (FL) patients treated in the second-line or later setting Epcoritamab in combination with R2 demonstrated sustained efficacy with manageable safety, regardless of baseline risk factors, including those traditionally associated with higher- or lower-risk disease factors Data were presented during an oral presentation at the 2026 European Hematology Association (EHA) Congress Genmab A/S (Nasdaq: GMAB) today announced new data from a post-hoc subgroup analysis from the pivotal Phase 3 EPCORE® FL-1 trial, evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, in combination with rituximab and lenalidomide (epcoritamab + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), which showed that epcoritamab + R2 delivered consistent and sustained efficacy benefits across clinically relevant subgroups, including Follicular Lymphoma International Prognostic Index (FLIPI) score (0–2 vs 3–5), progression of disease less than or equal to two years from the date of initial frontline therapy (POD24) (POD24 vs non-POD24), and patient fitness (non-Hodgkin lymphoma 5 score). These results were presented during an oral presentation (abstract S229) at the European Hematology Association (EHA) 2026 Congress held in Stockholm, Sweden, June 11 -14, 2026. “The EPCORE FL-1 trial, bolstered by this subgroup analysis, established fixed-duration epcoritamab in combination with R2 for relapsed or refractory follicular lymphoma,” said Benoit Tessoulin, M.D., Ph.D., Nantes University School of Medicine & University Hospital. “It delivers consistent efficacy and a manageable safety profile, regardless of comorbidity burden.” The EPCORE FL-1 trial randomized a total of 481 patients, with 243 receiving epcoritamab + R2 and 238 receiving R2 alone. The subgroup analysis of the Phase 3 EPCORE FL-1 trial was performed to assess the benefit and tolerability of epcoritamab + R2 across clinically relevant subgroups, including patients with higher- and lower-risk disease features, compared with standard of care R2. The data demonstrated that progression-free survival (PFS) benefits continued to favor epcoritamab + R2, with hazard ratios (HR) consistently below 0.3 across FLIPI 0–2 (0.18 [0.10–0.33]) and FLIPI 3–5 (0.25 [0.15–0.42]), POD24 (HR 0.22 [95% CI 0.13–0.37]), and non-Hodgkin lymphoma 5 (NHL-5) subgroups (low: HR 0.27 [0.17–0.42]; H+I, high and intermediate: HR 0.14 [0.06–0.29]), indicating a substantially reduced risk of disease progression or death. Additionally, overall response rates (ORR) were higher with the combination of epcoritamab and R² compared to R² alone across different FLIPI risk groups. For patients with FLIPI scores of 0–2, the ORR was 96.5% with the combination versus 84.8% for R2 alone. In patients with FLIPI scores of 3–5, the ORR was 93.0% with the combination compared to 72.6% with R2 alone. Moreover, complete response rates (CRR) were consistently higher with epcoritamab and R² across all analyzed subgroups. In patients with lower FLIPI scores (0–2), the CRR was 86.6% with the combination, compared to 62.1% for R2 alone. Among those with higher FLIPI scores (3–5), the CRR was 77.0% for the combination versus 35.4% for R² alone. Similar improvements in CRR were noted among non-POD24 patients (85.5% vs. 57.6%) and across various patient fitness categories, including NHL-5 low-risk patients (81.3% vs. 50.3%) and H+I patients (85.7% vs. 49.0%). The safety profile of epcoritamab + R2 was manageable across all patient subgroups and consistent with that observed in the overall trial population, with no new safety signals identified. Although adverse events such as neutropenia and infections were more frequent among patients receiving lower lenalidomide doses, the consistent and sustained efficacy of epcoritamab + R2 compared with R² alone was maintained in this subgroup. These findings are consistent with standard clinical practice, in which lenalidomide dose reductions are routinely implemented to manage adverse events while preserving treatment benefit in combination with epcoritamab. “The EPCORE FL-1 subgroup analysis demonstrated consistent and deep responses with a manageable safety profile across all patient characteristics, including varying risk profiles and lenalidomide dosing schedule, which validate the potential of the combination therapy,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “These data strongly reinforce our belief that epcoritamab, combined with rituximab and lenalidomide, is poised to transform the treatment paradigm, offering a highly effective and broadly accessible option for relapsed or refractory follicular lymphoma.” About the EPCORE® FL-1 Trial
EPCORE® FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). Patients were randomized to receive EPKINLY in combination with rituximab and lenalidomide (n=243) or rituximab and lenalidomide alone (n=245). Patients received EPKINLY in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR). More information on this trial can be found at www.clinicaltrials.gov/. About Follicular Lymphoma (FL)
Follicular lymphoma (FL) is typically an indolent, or slow-growing, form of non-Hodgkin lymphoma (NHL), that arises from B-lymphocytes. The second most common form of NHL, FL accounts for 20-30% of all NHL cases.i FL is considered incurable.ii Patients often relapse, and with each relapse the remission and time to next treatment shorten.iii Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients.iii,iv About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.v Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in more than 65 territories. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (DLBCL) indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. What is EPKINLY?
EPKINLY is a prescription medicine used to treat adults with: certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory) after 2 or more treatments. follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab follicular lymphoma (FL) that has come back or that did not respond after 2 or more treatments. EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children. IMPORTANT SAFETY INFORMATION
Important Warnings—EPKINLY can cause serious side effects, including: Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Neurologic problems that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. People with DLBCL or high-grade B-cell lymphoma may be hospitalized after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems. People with FL may be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion. Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets. The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include rash, upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab include decreased white blood cells and decreased platelets. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Medication Guide, including Important Warnings. About Genmab
Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd. ____________________ i Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed May 2026. ii Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421 iii Rivas-Delgado, A., Magnano, L., Moreno-Velázquez, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708 iv Al-Tourah AJ, Gill KK, Chhanabhai M, et al. Population-based analysis of incidence and outcome of transformed non-Hodgkin's lymphoma. J Clin Oncol. 2008 Nov 10;26(32):5165-9. doi: 10.1200/JCO.2008.16.0283. Epub 2008 Oct 6. PMID: 18838711. v Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625.   View source version on businesswire.com: https://www.businesswire.com/news/home/20260610500156/en/ David Freundel, Senior Director, Global Communications & Corporate Affairs
T: +1 609 613 0504; E: dafr@genmab.com Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com Original: Genmab Presents EPCORE® FL-1 Subgroup Data Demonstrating Consistent Efficacy and Safety Results for Epcoritamab in Combination with Rituximab and Lenalidomide (R2) Across Relapsed or Refractory (R/R) Follicular Lymphoma (FL) Patients

Genmab Presents the Safety and Tolerability of Rinatabart Sesutecan (Rina-S®) in Combination with Bevacizumab in Advanced Ovarian CancerApril 13, 2026 9:35 AM
Business Wire

Phase 1/2 RAINFOL™-01 data showed the combination of rinatabart sesutecan (Rina-S®) and bevacizumab was tolerable, with no new safety signals in patients with advanced ovarian cancer



The ongoing Phase 3 RAINFOL-04 trial will further evaluate the combination in patients with recurrent platinum-sensitive ovarian cancer (PSOC)



Genmab A/S (Nasdaq: GMAB) announced today new data demonstrating that rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha (FRa)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC), evaluated in combination with bevacizumab in patients with advanced ovarian cancer, showed a safety profile consistent with the known safety profiles of Rina-S and bevacizumab. These data are from the combination therapy cohort D2 of the multi-part Phase 1/2 RAINFOL™-01 study and were presented during an oral session at the 2026 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO) in San Juan, Puerto Rico.


“Advanced ovarian cancer is a complex and difficult-to-treat disease, and the ability for investigational therapies such as Rina-S to be safely combined with bevacizumab can provide clinicians with more options to help improve disease control and manage resistance,” said Cara Mathews, M.D., study investigator and Associate Professor, Obstetrics and Gynecology at the Women and Infants Hospital, Brown University. “Rina-S has shown a manageable safety profile as a monotherapy, and these safety data suggest that it may be combined with a standard-of-care therapy such as bevacizumab without significantly increasing the risk of additional side effects.”


As of data cutoff, 40 patients with recurrent ovarian cancer had received Rina-S (120 mg/m2) plus bevacizumab every three weeks until disease progression or unacceptable toxicity. The primary endpoint was safety and tolerability. The combination of Rina-S and bevacizumab was tolerable, with manageable adverse events (AEs). The safety profile of the combination was consistent with the known safety profiles of the individual agents, with no new or unexpected safety signals. The most common (≥25%) treatment-emergent AEs (TEAEs) included nausea (80%), fatigue (67.5%), anemia (55%), and neutropenia (45%). No safety signals of ocular toxicities, peripheral neuropathy or interstitial lung disease were reported, and no clinically significant bleeding was observed. Serious TEAEs occurred in six patients (15.0%), and TEAEs leading to Rina-S dose reductions occurred in 11 patients (27.5%). Rina-S and bevacizumab discontinuation occurred in two patients (5%). No fatal TEAEs were reported.


“Today’s safety results from RAINFOL-01 add to the growing body of clinical evidence supporting further development of Rina-S in advanced ovarian cancer, including its potential to be used in a combination regimen,” said Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab. “Rina-S has the potential to meaningfully expand treatment possibilities for patients with certain gynecologic cancers, and we look forward to further investigating additional opportunities, alone and with other therapies, as Rina-S advances through late-stage clinical development.”


Rina-S is advancing through late-stage development supported by a growing portfolio of clinical trials, including the ongoing Phase 1/2 RAINFOL-01 trial (NCT05579366), the Phase 3 RAINFOL-02 trial (NCT06619236) in patients with platinum-resistant ovarian cancer (PROC), the Phase 3 RAINFOL-03 trial (NCT07166094) in patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy, and the Phase 3 RAINFOL-04 trial (NCT07225270) in patients with recurrent platinum-sensitive ovarian cancer (PSOC) as maintenance therapy. Rina-S is also being evaluated in the Phase 2 RAINFOL-05 study (NCT07288177) in patients with non-small cell lung cancer (NSCLC).


About the RAINFOL-01 Trial

RAINFOL-01 (NCT05579366) is an open-label, multicenter Phase 1/2 study designed to evaluate the safety and efficacy of Rina-S Q3W at various doses in solid tumors that are known to express FRa. The study consists of multiple parts including Part D combination therapy cohorts.


About Ovarian Cancer

Ovarian cancer is a major global health issue, with over 320,000 new cases diagnosed annually worldwide.i It ranks as the eighth most common cancer and the eighth leading cause of cancer-related deaths among women globally.ii The disease is often diagnosed at an advanced stage due to its subtle and non-specific symptoms, such as abdominal bloating, pelvic pain and difficulty eating.iii Standard of care for PROC typically involves single-agent chemotherapy (pegylated liposomal doxorubicin (PLD), topotecan, gemcitabine or paclitaxel) and mirvetuximab for FRa-positive (≥75% positive tumor cells) patients.iv,v Approximately 70-90% of women with advanced-stage ovarian cancer worldwide experience a recurrence after initial treatment.vi Ovarian cancer has a low five-year survival rate, which varies significantly by region, but generally hovers around 30-50%.vii,viii


About Rinatabart Sesutecan (Rina-S; GEN1184)

Rina-S (GEN1184) is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRa, a hydrophilic protease-cleavable linker, and exatecan, a TOPO1 inhibitor payload. The clinical trial program for Rina-S continues to expand, including ovarian, endometrial and other cancers with unmet need.


The safety and efficacy of Rina-S has not been established. Please visit https://clinicaltrials.gov/ for more information.


About Genmab

Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody-drug conjugates (ADCs), immune-modulating antibodies, and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients.


Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.


This Media Release contains forward-looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward-looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward-looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.


Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect®, KYSO® and RAINFOL™; Rina-S® is a trademark of ProfoundBio, US, Co. and Genmab (Suzhou) Co., Ltd.



_________________________



i World Cancer Research Fund International. https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics/. Accessed Oct 2025.




ii World Ovarian Cancer Coalition. https://worldovariancancercoalition.org/about-ovarian-cancer/key-stats/. Accessed Oct 2025.




iii Dilley, James et al. Ovarian cancer symptoms, routes to diagnosis and survival - Population cohort study in the 'no screen' arm of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Gynecologic oncology vol. 158,2 (2020): 316-322. doi:10.1016/j.ygyno.2020.05.002.




iv Eskander RN, Moore KN, Monk BJ, Herzog TJ, Annunziata CM, O’Malley DM and Coleman RL (2023) Overcoming the challenges of drug development in platinum-resistant ovarian cancer. Front. Oncol. 13:1258228.




v National Comprehensive Cancer Network (NCCN). NCCN Guidelines for Patients®: Ovarian Cancer. Version 3.2024. July 15, 2024. https://www.nccn.org/patients/guidelines/content/PDF/ovarian-patient.pdf




vi Ovarian Cancer Research Alliance. https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/




vii European Institute of Women's Health. https://eurohealth.ie/policy-brief-women-and-ovarian-cancer-in-the-eu-2018/. Accessed Oct 2025.




viii American Cancer Society. Stages of Ovarian Cancer. https://www.cancer.org/cancer/types/ovarian-cancer/detection-diagnosis-staging/survival-rates.html. Accessed Oct 2025.







 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260410050131/en/
David Freundel, Senior Director, Global Communications & Corporate Affairs

T: +1 609 613 0504; E: dafr@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: acn@genmab.com


Original: Genmab Presents the Safety and Tolerability of Rinatabart Sesutecan (Rina-S®) in Combination with Bevacizumab in Advanced Ovarian Cancer

$170B Patent Cliff Ignites Biotech Deal Wave: Late-Stage Platforms Command PremiumJanuary 30, 2026 10:36 AM
PR Newswire (US)

Issued on behalf of Oncolytics Biotech Inc.Equity-Insider.com News Commentary VANCOUVER, BC, Jan. 30, 2026 /PRNewswire/ -- The oncology sector is undergoing a massive capital rotation driven by over 50 FDA approvals in 2025, with 20 arriving in Q4 alone[1]. This regulatory surge signals deep institutional confidence in late-stage platforms capable of commercial conversion. The trend accelerated in January 2026 as Big Pharma intensified its race to acquire assets ahead of a $170 billion patent cliff[2]. Acquirers are now bypassing early-stage speculation to secure validated Phase 3 data and manufacturing infrastructure. This structural shift has directed institutional focus toward Oncolytics Biotech Inc. (NASDAQ: ONCY), AbbVie (NYSE: ABBV), Genmab (NASDAQ: GMAB), ADC Therapeutics (NYSE: ADCT), and Greenwich LifeSciences (NASDAQ: GLSI).  Institutions are prioritizing platforms that can navigate Phase 3 trials, where approximately 50% of candidates still fail[3]. Demonstrated regulatory alignment has become the critical de-risking factor for capital allocation. This environment creates asymmetric upside for organizations that have secured the FDA's flexible approach to BLA submissions and manufacturing validation[4]. The market is now placing a premium on specialized leadership combined with registration-enabling data in commercial-scale disease categories.Oncolytics Biotech Inc. (NASDAQ: ONCY) is building out its leadership team as it moves its cancer treatment pelareorep through late-stage clinical trials targeting several gastrointestinal cancers.The company recently announced two key hires: John McAdory as Executive Vice President of Strategy and Operations, and Yujun Wu as Vice President, Head of Biostatistics. McAdory comes from CG Oncology, where he ran late-stage clinical trials for oncolytic virus therapies (cancer-fighting viruses, similar to pelareorep). Wu joins from Morphic Therapeutic, where he led the statistics department through the company's sale to Eli Lilly, and previously designed multiple Phase 3 oncology trials at Takeda. Both bring the specific expertise needed to execute the complex, multi-country registration trials that determine whether a drug gets FDA approval."John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."These hires complete a significant management upgrade. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024. The company also added three leading cancer specialists from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center to its gastrointestinal tumor scientific advisory board.The clinical data driving this expansion looks compelling. In colorectal cancer, pelareorep combined with chemotherapy and a vascular endothelial growth factor (VEGF) inhibitor achieved a 33% response rate in patients with KRAS mutations (a genetic marker found in about 40% of colorectal cancers). That's three times better than the 6-11% response rate chemotherapy and a VEGF inhibitor typically achieves in these patients. Response rate measures the percentage of patients whose tumors shrink significantly or disappear entirely.In anal cancer, where treatment options are extremely limited after first-line therapy fails, pelareorep is showing even stronger results. Third-line patients (those who've already failed two prior treatments) saw a 29% response rate with responses lasting around 17 months. That nearly triples the historical benchmarks in a setting where no FDA-approved treatments currently exist.In second-line patients, the 30% response rate more than doubled the 13.8% benchmark for the only FDA-approved immunotherapy available, with responses lasting 15.5 months versus 9.5 months for standard treatment.Oncolytics has also secured FDA agreement on its Phase 3 trial design for pancreatic cancer, clearing the way to launch what would be the only immunotherapy registration trial currently planned for this notoriously difficult-to-treat disease.CONTINUED… Read this and more news for Oncolytics Biotech at: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other recent industry developments and happenings in the market include:AbbVie (NYSE: ABBV) along with partner Genmab (NASDAQ: GMAB) announced topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating epcoritamab in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study demonstrated improvement in progression-free survival with a hazard ratio of 0.74, along with improvements in complete response rates and duration of response, though overall survival did not reach statistical significance.EPCORE DLBCL-1 is the first Phase 3 study to demonstrate PFS improvement in patients with relapsed/refractory DLBCL treated with a CD3xCD20 T-cell engaging bispecific monotherapy. AbbVie and Genmab will engage global regulatory authorities to discuss next steps while continuing to evaluate epcoritamab across treatment lines and hematologic malignancies.ADC Therapeutics (NYSE: ADCT) reported preliminary full-year 2025 ZYNLONTA net product revenue of approximately $73 million, up from $69.3 million in 2024, with fourth quarter revenue of approximately $22 million representing growth from $16.4 million in the prior-year period. Updated data from the LOTIS-7 Phase 1b trial demonstrated an 89.8% best overall response rate and 77.6% complete response rate across 49 efficacy-evaluable patients with relapsed or refractory diffuse large B-cell lymphoma."During 2025, we delivered meaningful progress across our ZYNLONTA clinical program and extended our expected cash runway at least to 2028," said Ameet Mallik, CEO of ADC Therapeutics. "Assuming positive results, we anticipate potential compendia inclusion for each in the first half of 2027 with LOTIS-5 regulatory approvals to follow."The company expects topline data from its LOTIS-5 Phase 3 confirmatory trial in second-quarter 2026, with cash and cash equivalents of approximately $261 million providing runway at least to 2028. ADC Therapeutics has also completed IND-enabling activities for its PSMA-targeting ADC program.Greenwich LifeSciences (NASDAQ: GLSI) announced the FDA has reviewed and approved the use of the first commercial lot of GP2 vials in its Phase III FLAMINGO-01 trial evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrences. Preliminary analysis from the non-HLA-A*02 arm shows approximately 80% reduction in recurrence rate, trending similarly to Phase IIb trial results."With our manufacturing investments in 2023 and 2024, and now the FDA's review and approval to use the first commercial lot of finished GP2 vials in FLAMINGO-01, we have taken major steps to further de-risk the filing of a BLA in the US," said Snehal Patel, CEO of Greenwich LifeSciences. "We plan to start using these new GP2 vials in the coming weeks at all 40 US sites."The 250-patient non-HLA-A*02 arm is now fully enrolled, representing five times more treated patients than the Phase IIb trial. Greenwich LifeSciences holds Fast Track designation for GLSI-100 and plans to submit manufacturing data to regulatory agencies in Europe, the United Kingdom, and Canada.Source: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:
Equity Insider
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.aacr.org/blog/2026/01/06/fda-approvals-in-oncology-october-december-2025/ https://www.cnbc.com/2026/01/07/big-pharma-race-to-snap-up-biotech-assets-as-170-billion-patent-cliff-looms.html https://www.appliedclinicaltrialsonline.com/view/phase-iii-trial-failures-costly-preventable https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/flexible-requirements-cell-and-gene-therapies-advance-innovationLogo: https://mma.prnewswire.com/media/2840019/Equity_Insider_Logo.jpg





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Original: $170B Patent Cliff Ignites Biotech Deal Wave: Late-Stage Platforms Command Premium

Products in development
Genmab is developing a pipeline of antibody therapeutics with eighteen products in clinical development, including two marketed products, and approximately 20 in-house and partnered pre-clinical programs. Our pipeline currently includes naked antibodies, Antibody Drug Conjugates (ADCs), bispecific antibodies created from our DuoBody® technology platform, and antibodies created with our HexaBody® technology.


http://www.genmab.com/product-pipeline/products-in-development

Product pipeline
Genmab has two partnered products on the market, DARZALEX® (daratumumab) and Arzerra® (ofatumumab), and is developing a clinical pipeline of antibody therapeutics for the treatment of cancer.


http://www.genmab.com/product-pipeline

About Genmab A/S
Genmab A/S operates as a biotechnology company. The Company specializes in development of antibody therapeutics for the treatment of cancer. Genmab serves customers worldwide.


ADDRESS
Kalvebod Brygge 43 Copenhagen V, 1560 Denmark
PHONE
45-7020-2728
WEBSITE
www.genmab.com






https://www.bloomberg.com/quote/GMXAY:US

GMXAY largest holding in Blackrock fund:

iShares Genomics Immunology and Healthcare ETF


https://www.blackrock.com/us/individual/products/308878/

Genmab Announces Phase II Study of Daratumumab in Non-Hodgkin's Lymphomas

[GlobeNewswire] - Company Announcement

read full: http://finance.yahoo.com/news/genmab-announces-phase-ii-study-063632870.html

GMXAY Forward Split 5 for 1 effective May 1, 2018

http://otce.finra.org/DailyList

Here are Two Biotech Stocks to Watch in January - article mentions Genmab

http://marketexclusive.com/here-are-two-biotech-stocks-to-watch-in-january/1228/

$GMXAY DD Notes ~ http://www.ddnotesmaker.com/GMXAY

bullish

$GMXAY recent news/filings

## source: finance.yahoo.com

Thu, 04 Dec 2014 06:36:32 GMT ~ Genmab Announces Phase II Study of Daratumumab in Non-Hodgkin's Lymphomas

[GlobeNewswire] - Company Announcement

read full: http://finance.yahoo.com/news/genmab-announces-phase-ii-study-063632870.html
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Mon, 24 Nov 2014 13:53:34 GMT ~ Genmab Announces Phase II Study of Daratumumab in Smoldering Multiple Myeloma

[GlobeNewswire] - Company Announcement

read full: http://finance.yahoo.com/news/genmab-announces-phase-ii-study-135334071.html
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Mon, 10 Nov 2014 08:17:15 GMT ~ Genmab Announces New Phase III Combination Study of Daratumumab in Frontline Multiple Myeloma

[GlobeNewswire] - Company Announcement

read full: http://finance.yahoo.com/news/genmab-announces-phase-iii-combination-081715458.html
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Thu, 06 Nov 2014 14:40:06 GMT ~ Genmab Announces Daratumumab and Ofatumumab Data to Be Presented at American Society of Hematology Annual Meeting (ASH)

[GlobeNewswire] - Media Release

read full: http://finance.yahoo.com/news/genmab-announces-daratumumab-ofatumumab-data-144006800.html
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Thu, 06 Nov 2014 14:10:48 GMT ~ Genmab Announces Additional Data from Phase III Study of Ofatumumab as Maintenance Therapy for Relapsed CLL

[GlobeNewswire] - COPENHAGEN, Denmark -- Genmab A/S (OMX: GEN) announced today additional data from the interim analysis of the ofatumumab (Arzerra(tm)) Phase III study, PROLONG (OMB112517). The study evaluated ofatumumab ...

read full: http://finance.yahoo.com/news/genmab-announces-additional-data-phase-141048186.html
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$GMXAY charts

basic chart ## source: stockcharts.com



basic chart ## source: stockscores.com



big daily chart ## source: stockcharts.com



big weekly chart ## source: stockcharts.com


$GMXAY company information

## source: otcmarkets.com

Link: http://www.otcmarkets.com/stock/GMXAY/company-info
Ticker: $GMXAY
OTC Market Place: OTC Pink Current
CIK code: 0001434265
Company name: Genmab A/S
Company website: http://www.genmab.com
Incorporated In: Denmark

Business Description: Genmab is an international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer.


$GMXAY share structure

## source: otcmarkets.com

Market Value: $2,578,167,309 a/o Dec 03, 2014
Shares Outstanding: 51,052,818 a/o Jul 30, 2013
Float: Not Available
Authorized Shares: Not Available
Par Value: Not Available
$GMXAY extra dd links

Company name: Genmab A/S
Company website: http://www.genmab.com

## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=GMXAY+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=GMXAY+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=GMXAY+Industry

## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/GMXAY/news - http://finance.yahoo.com/q/h?s=GMXAY+Headlines

## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/GMXAY/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/GMXAY/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=GMXAY+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/GMXAY
DTCC (dtcc.com): http://search2.dtcc.com/?q=Genmab+A%2FS&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Genmab+A%2FS
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Genmab+A%2FS&x=0&y=0
WHOIS (domaintools.com): http://whois.domaintools.com/http://www.genmab.com
Alexa (alexa.com): http://www.alexa.com/siteinfo/http://www.genmab.com#
Corporate website internet archive (archive.org): http://web.archive.org/web/*/http://www.genmab.com

## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/GMXAY
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001434265&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/GMXAY/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/GMXAY/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=GMXAY&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=GMXAY
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/GMXAY/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=GMXAY+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=GMXAY+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=GMXAY
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=GMXAY
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=GMXAY+Cash+Flow&annual

## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/GMXAY/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=GMXAY+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/GMXAY.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=GMXAY
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/GMXAY/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/GMXAY/insider-transactions

## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/GMXAY
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/GMXAY
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/GMXAY:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=GMXAY
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=GMXAY



$GMXAY DD Notes ~ http://www.ddnotesmaker.com/GMXAY

Genmab has taken a beating along with a lot of american Biotech. It is poised for a lot of news starting the 19th of april with a PDUFA date on their submission on 1st line CLL drug Arzerra. For those of you unfamiliar with this Company I will be posting news regularly and tell you something about the history.