Phase 3 EPCORE DLBCL-1 Trial of Epcoritamab Fails to Meet the U.S. Overall Survival Endpoint – Genmab and AbbVie
Genmab and AbbVie provided clarification on the primary endpoints from the Phase 3 EPCORE DLBCL-1 study evaluating monotherapy epcoritamab (DuoBody-CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, compared with investigator’s choice of chemoimmunotherapy (CIT) of either rituximab plus gemcitabine plus oxaliplatin (R-GemOx) or bendamustine plus rituximab (BR) in adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who were ineligible for autologous stem cell transplantation.
Genmab and AbbVie previously announced topline results of the study on January 16, 2026, and additional study results were subsequently presented at the European Hematology Association (EHA) 2026 Congress on June 12, 2026.
EPCORE DLBCL-1 is a global, Phase 3, open label, multi-center, randomized clinical trial with prespecified primary endpoints that differ by region. In the United States, where overall survival (OS) is the sole primary endpoint, the study did not demonstrate a statistically significant improvement in OS and therefore did not meet its primary endpoint.
Additional results of the EPCORE DLBCL-1 study will be submitted for publication in a peer-reviewed medical journal.
About the EPCORE DLBCL-1 Trial
EPCORE DLBCL-1 (NCT04628494) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody-CD3xCD20) compared to investigator’s choice of chemotherapy, either rituximab plus gemcitabine plus oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR), in patients with relapsed or refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The trial started on January 13, 2021, and is ongoing.
More information on this trial can be found at https://www.clinicaltrials.gov/.
