Genmab (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) announced results from the Phase 3 EPCORE DLBCL-2 trial showing that epcoritamab combined with R-CHOP chemotherapy significantly improved progression-free survival in patients newly diagnosed with diffuse large B-cell lymphoma (DLBCL).

The trial demonstrated a 51% reduction in the risk of disease progression or death among patients with an International Prognostic Index score of 2 to 5, compared to R-CHOP alone (HR 0.49 [95% CI 0.36, 0.67]; p-value <0.0001). The companies describe the combination as an investigational treatment not yet approved by regulatory authorities.

The EPCORE DLBCL-2 trial is a global, open-label, randomized Phase 3 study. Patients were randomized 2:1 to receive epcoritamab plus R-CHOP for six cycles followed by epcoritamab alone for two cycles, or R-CHOP for six cycles followed by rituximab for two cycles. The trial began February 8, 2023, and is ongoing.

The companies said the safety profile of epcoritamab in combination with R-CHOP was generally consistent with previously reported safety profiles of the individual agents.

Genmab and AbbVie said they plan to engage global regulatory authorities to determine next steps. Full data will be submitted for presentation at a future medical meeting.

Epcoritamab, a subcutaneously administered T-cell engaging bispecific antibody, is already approved under the brand names Epkinly in the U.S. and Japan, and Tepkinly in the EU, for certain other lymphoma indications in more than 65 countries.

DLBCL is the most common type of non-Hodgkin lymphoma worldwide, accounting for approximately 25-30% of all non-Hodgkin lymphoma cases. In the U.S., approximately 25,000 new cases are diagnosed each year, according to the Leukemia and Lymphoma Society.