AbbVie has announced topline results from the global Phase III Epcore DLBCL-1 trial evaluating epcoritamab, a subcutaneous CD3xCD20 T-cell engaging bispecific antibody, in adult patients with Relapsed or Refractory (R/R) diffuse large B-cell Lymphoma (DLBCL).

The study met its primary endpoint, demonstrating a significant improvement in Progression-Free Survival (PFS) compared with the investigator's choice of chemoimmunotherapy, with a hazard ratio of 0.74 (95 percent CI: 0.60–0.92). Patients treated with epcoritamab also showed improvements in complete response rate, duration of response, and time to next treatment. However, the trial did not show a statistically significant improvement in overall survival (HR: 0.96; 95 percent CI: 0.77–1.20).

Epcore DLBCL-1 is the first Phase III study to demonstrate a PFS benefit with a CD3xCD20 T-cell engaging bispecific antibody used as monotherapy in patients with R/R DLBCL. The trial enrolled 483 patients globally, all of whom had received at least one prior line of therapy, with nearly three-quarters having undergone two or more prior treatments. Participants were ineligible for high-dose chemotherapy and autologous stem cell transplant.

The safety profile observed in the study was consistent with the known safety of epcoritamab. AbbVie and Genmab noted that several external factors, including the conduct of the trial during the peak of the Covid-19 Omicron wave and the evolving availability of novel lymphoma therapies, may have influenced outcomes. Detailed results will be submitted for presentation at a future medical congress, and discussions with global regulatory authorities are planned to determine next steps.

DLBCL is the most common form of non-Hodgkin lymphoma, accounting for approximately 25–30 percent of cases worldwide. Despite advances in treatment, many patients experience relapse or refractory disease, highlighting the need for new therapeutic options.

Epcoritamab, marketed as Epkinly in the US and Japan and Tepkinly in the European Union, is already approved for certain lymphoma indications in more than 65 countries. The therapy is co-developed by AbbVie and Genmab using Genmab’s DuoBody technology and is being evaluated across multiple lines of therapy and hematologic malignancies, both as monotherapy and in combination regimens.