US pharmaceutical company AbbVie (NYSE:ABBV) and Danish biotechnology company Genmab A/S (CPH:GMAB) on Monday reported positive topline results from the Phase 3 EPCORE DLBCL-2 trial evaluating fixed treatment duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with standard of care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), compared to R-CHOP alone, in newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL) with an International Prognostic Index (IPI) score of 2 to 5.

According to the companies, the trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in DLBCL patients with an IPI score of 2 to 5. The safety profile of epcoritamab when administered in combination with standard of care R-CHOP was generally well tolerated and consistent with the previously reported safety profiles of the individual agents (epcoritamab and R-CHOP).

This was the first planned efficacy interim analysis of the EPCORE DLBCL-2 study and, based on the significant benefit, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study.

DLBCL is the most common type of non-Hodgkin lymphoma worldwide, accounting for approximately 25-30% of all NHL cases.

AbbVie and Genmab say that they will engage global regulatory authorities to determine next steps. Data will be submitted for presentation at a future medical meeting.