Genmab and AbbVie released a statement indicating that overall survival (OS) was the sole US primary endpoint in the Phase III EPCORE DLBCL-1 trial of epcoritamab (Epkinly/Tepkinly) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), confirming that the study failed to meet the endpoint required to support full US approval.
The clarification follows topline results reported in January and detailed data presented at the European Hematology Association (EHA) Congress in June, which showed epcoritamab improved progression-free survival, complete response rate, duration of response and time to next treatment versus investigator's choice of chemoimmunotherapy. However, overall survival was not significantly improved (HR 0.96; 95% CI 0.77-1.20).
EPCORE DLBCL-1 enrolled 483 transplant-ineligible patients with relapsed or refractory DLBCL who had received at least one prior line of therapy. Patients were randomized to receive subcutaneous epcoritamab or investigator's choice of R-GemOx or bendamustine plus rituximab.
Epcoritamab is a CD3xCD20 bispecific antibody built on Genmab's DuoBody platform that redirects T cells to kill CD20-positive B cells. The drug received accelerated US FDA approval in 2023 for relapsed or refractory DLBCL after two or more prior lines of therapy based on response data from the Phase I/II EPCORE NHL-1 study.