Genmab and AbbVie clarify EPCORE DLBCL-1 US primary endpoint not met

Clarification of primary endpoint

Genmab and AbbVie state that in the Phase 3 EPCORE DLBCL-1 trial the prespecified primary endpoints differ by region and that overall survival (OS) was the sole primary endpoint in the United States. The study did not demonstrate a statistically significant improvement in OS and therefore did not meet its U.S. primary endpoint.

Trial design

EPCORE DLBCL-1 is a global, Phase 3, open-label, multi-center, randomized trial that began on January 13, 2021, and is ongoing. It evaluated subcutaneous epcoritamab (DuoBody‑CD3xCD20) as monotherapy versus investigator's choice of chemoimmunotherapy—either rituximab plus gemcitabine plus oxaliplatin (R‑GemOx) or bendamustine plus rituximab (BR)—in adults with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) who were ineligible for high‑dose chemotherapy and autologous stem cell transplant.

Epcoritamab status

Epcoritamab is an IgG1 bispecific antibody that binds CD3 and CD20 and is administered subcutaneously. It has accelerated FDA approval for the treatment of adult patients with R/R DLBCL after two or more lines of systemic therapy and has received regulatory approvals in multiple territories.

Next steps

Genmab and AbbVie said additional EPCORE DLBCL-1 results will be submitted for publication in a peer‑reviewed medical journal. The companies noted ongoing clinical programs, including EPCORE DLBCL-2 with data anticipated in 2026 and recent topline disclosure from EPCORE DLBCL-4 assessing a chemotherapy‑free combination.