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]
Genmab Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)