Epcoritamab delayed progression but did not clearly extend life versus chemotherapy in relapsed lymphoma, missing its US primary endpoint in January 2026.
EPCORE DLBCL-1, trial NCT04628494 sponsored by Genmab and AbbVie and reported on 16 January 2026, was the confirmatory phase 3 for epcoritamab in relapsed or refractory diffuse large B-cell lymphoma after at least one line in transplant-ineligible patients, and it delayed progression but did not clearly extend life against investigator's choice of rituximab-gemcitabine-oxaliplatin or bendamustine-rituximab. It randomised 552 patients and improved progression-free survival, but overall survival, the sole primary endpoint in the United States, was not significantly different, so the study did not meet its US endpoint while the dual endpoints used elsewhere were partially met. The regulatory implications for the accelerated approval were under discussion, and whether a bispecific alone can beat chemotherapy on survival is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
552 enrolled.
Numbers not yet public.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Epcoritamab | - | - | 0.96 (0.77 to 1.2) | - | link |
| Investigator's choice | - | - | ||||
| Progression-free survival | Epcoritamab | - | - | 0.74 (0.6 to 0.92) | - | - |
| Investigator's choice | - | - |
Shares ctDNA-guided escalation and de-escalation in frontline DLBCL, Catherine Thieblemont, CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one, EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T.
Shares ctDNA-guided escalation and de-escalation in frontline DLBCL, Epcoritamab, Genmab, T-cell engagers (bispecific).
Shares ctDNA-guided escalation and de-escalation in frontline DLBCL, Epcoritamab, Genmab, T-cell engagers (bispecific).
Shares Epcoritamab, Genmab, T-cell engagers (bispecific), Diffuse large B-cell lymphoma.
Shares ctDNA-guided escalation and de-escalation in frontline DLBCL, Epcoritamab, Genmab, T-cell engagers (bispecific).
Shares Epcoritamab, Genmab, T-cell engagers (bispecific), Diffuse large B-cell lymphoma.
Shares Epcoritamab, Genmab, T-cell engagers (bispecific).
Shares Epcoritamab, Genmab, T-cell engagers (bispecific).