EPKINLY (epcoritamab-bysp) - (DLBCL-1 )

July 23, 2026: Genmab A/S (NASDAQ: GMAB) and AbbVie (NYSE: ABBV) clarified that in the Phase 3 EPCORE DLBCL-1 trial (NCT04628494) of subcutaneous epcoritamab monotherapy (DuoBody-CD3xCD20) vs investigator’s choice chemoimmunotherapy (R-GemOx or BR) in adults with relapsed/refractory diffuse large B-cell lymphoma ineligible for autologous stem cell transplant, overall survival (OS) was the sole U.S. primary endpoint and it was not met (no statistically significant OS improvement). The trial has prespecified primary endpoints that differ by region.

The companies previously announced topline results on January 16, 2026, with additional results presented at the EHA 2026 Congress on June 12, 2026; further results are planned for submission to a peer-reviewed journal.

The release notes epcoritamab is FDA accelerated approval–authorized for certain adult R/R DLBCL/high-grade B-cell lymphoma after ≥2 prior systemic therapies, with confirmatory studies ongoing. Upcoming catalysts mentioned: EPCORE DLBCL-2 (fixed-duration epcoritamab + R-CHOP in newly diagnosed DLBCL) data anticipated in 2026.