Core Insights - AbbVie and Genmab announced topline results from the Phase 3 EPCORE DLBCL-1 trial, showing that epcoritamab improved progression-free survival (PFS) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) compared to standard chemoimmunotherapy [2][3] Group 1: Trial Results - The EPCORE DLBCL-1 trial demonstrated a PFS improvement with a hazard ratio (HR) of 0.74 (95% CI 0.60 to 0.92), indicating a statistically significant benefit [2][3] - Improvements were also noted in complete response rates (CRR), duration of response (DoR), and time to next treatment for patients receiving epcoritamab [2] - However, the trial did not show a statistically significant improvement in overall survival (OS) with an HR of 0.96 (95% CI 0.77 to 1.20) [2] Group 2: Study Details - The trial enrolled 483 patients with R/R DLBCL, with 73% having received two or more prior lines of therapy, and all patients were ineligible for high-dose chemotherapy and autologous stem cell transplant [3] - EPCORE DLBCL-1 is the first Phase 3 study to show PFS improvement using a CD3xCD20 T-cell engaging bispecific monotherapy [3] Group 3: Safety and Regulatory Actions - Adverse events observed were consistent with the known safety profile of epcoritamab, and the companies are assessing the impact of external factors such as the COVID-19 pandemic on trial outcomes [4] - AbbVie and Genmab plan to engage global regulatory authorities to discuss next steps following the trial results [4] Group 4: Background on DLBCL - DLBCL accounts for approximately 25-30% of all non-Hodgkin lymphoma (NHL) cases, with around 25,000 new cases diagnosed annually in the U.S. [5] - This type of lymphoma is fast-growing and primarily affects B-cell lymphocytes, with management remaining challenging despite new therapies [5] Group 5: Epcoritamab Overview - Epcoritamab, known as EPKINLY in the U.S. and Japan, and TEPKINLY in the EU, has received regulatory approval in over 65 countries for certain lymphoma indications [6][9] - The drug is being evaluated in ongoing clinical programs as both a monotherapy and in combination regimens across various hematologic malignancies [6][10]

Core Insights - Genmab announced topline results from the Phase 3 EPCORE DLBCL-1 trial, showing that epcoritamab monotherapy improved progression-free survival (PFS) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [1][2] - The trial demonstrated an overall survival (OS) hazard ratio of 0.96, which did not reach statistical significance [1] - Genmab and AbbVie will engage with global regulatory authorities to discuss next steps following the trial results [3] Study Details - The EPCORE DLBCL-1 trial enrolled 483 patients with R/R DLBCL, with 73% having received two or more prior lines of therapy [2] - The study compared epcoritamab monotherapy to investigator's choice of chemotherapy regimens, including rituximab plus gemcitabine and oxaliplatin (R-GemOx) or bendamustine plus rituximab (BR) [2][8] - The trial is ongoing and started on January 13, 2021 [8] Safety and Efficacy - Adverse events observed were consistent with the known safety profile of epcoritamab [3] - Further analysis of results is ongoing, considering factors like the COVID-19 pandemic and the availability of new anti-lymphoma therapies [3] Future Trials - Data is expected in 2026 from two additional Phase 3 trials evaluating epcoritamab in different treatment settings for DLBCL [4] - These trials include EPCORE DLBCL-2, assessing epcoritamab in combination with standard-of-care R-CHOP, and EPCORE DLBCL-4, comparing epcoritamab with lenalidomide against chemo-immunotherapy [4][12] Company Commitment - Genmab's CEO emphasized the significance of the EPCORE DLBCL-1 trial results in supporting epcoritamab as a core therapy for B-cell malignancies [5] - Epcoritamab has received regulatory approval in over 65 countries for certain lymphoma indications and is co-developed with AbbVie [5][11]