Genmab and AbbVie’s Epcoritamab Misses Overall Survival Endpoint but Meets PFS in Phase 3 DLBCL Trial
Genmab and AbbVie announced topline results from the Phase 3 EPCORE DLBCL-1 trial on January 16, 2026, evaluating epcoritamab (Epkinly/TEPKINLY) monotherapy in 483 patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) ineligible for high-dose chemotherapy and autologous stem cell transplant.
The trial missed the primary endpoint of overall survival (OS HR:
0.96 [95% CI 0.77-1.20]), which did not reach statistical significance.
Epcoritamab met the key secondary endpoint of progression-free survival (PFS HR:
0.74 [95% CI 0.60-0.92]), reducing risk by 26%, with improvements in complete response rate, duration of response, and time to next treatment.
This is the first Phase 3 trial to show PFS improvement with a CD3xCD20 bispecific antibody monotherapy in R/R DLBCL.
Companies will engage global regulatory authorities on next steps; additional Phase 3 data expected in 2026 from EPCORE DLBCL-2 (frontline with R-CHOP) and EPCORE DLBCL-4 (with lenalidomide).
Analysts view the OS miss as disappointing but maintain optimism for the program, believing it unlikely to affect accelerated approval.