North Chicago / Copenhagen – October 05, 2026 -- AbbVie and Genmab A/S reported that epcoritamab combined with standard R-CHOP chemotherapy reduced the risk of disease progression or death by 51% versus R-CHOP alone in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients, based on topline Phase 3 data.

Trial hits statistical significance with hazard ratio of 0.49

The Phase 3 EPCORE DLBCL-2 study showed a hazard ratio of 0.49 (95% CI 0.36-0.67; p-value less than 0.0001) for progression-free survival in patients with an International Prognostic Index (IPI) score of 2 to 5. For the trial's primary endpoint population, patients with IPI scores of 3 to 5, the hazard ratio was also 0.49 (95% CI 0.35-0.69; p-value less than 0.0001).

First bispecific antibody combination to clear frontline DLBCL bar

EPCORE DLBCL-2 marks the first Phase 3 study of a bispecific antibody combination therapy to demonstrate statistically significant and clinically meaningful progression-free survival improvement in frontline DLBCL. The safety profile of epcoritamab with R-CHOP was consistent with previously reported profiles of the individual agents, according to the companies.

Independent monitoring committee recommends unblinding after interim analysis

The result emerged from the first planned efficacy interim analysis of the trial, prompting the Independent Data Monitoring Committee to recommend unblinding the study. Patients were randomized 2:1 to receive six cycles of epcoritamab plus R-CHOP followed by two cycles of epcoritamab alone, or six cycles of R-CHOP followed by two cycles of rituximab. The trial, registered as NCT05578976, began enrollment on February 8, 2023, and remains ongoing.

Companies to engage regulators as DLBCL affects 25,000 new U.S. patients annually

AbbVie and Genmab said they will engage global regulatory authorities on next steps, with data to be submitted for presentation at a future medical meeting. DLBCL accounts for approximately 25-30% of all non-Hodgkin lymphoma cases worldwide, with roughly 25,000 new diagnoses annually in the United States. The epcoritamab-R-CHOP combination remains investigational and has not received regulatory approval.

Gilles Salles, Chief of the Lymphoma Service at Memorial Sloan Kettering Cancer Center, called the 51% risk reduction "clinically meaningful and highly relevant to everyday practice," noting the results could mark a step toward curing more patients in the frontline setting.

Epcoritamab, marketed as EPKINLY in the U.S. and Japan and TEPKINLY in the EU, has already secured regulatory approval in certain relapsed or refractory lymphoma indications across more than 65 countries under the companies' existing oncology collaboration.