AbbVie has announced topline results from the phase 3 EPCORE DLBCL-4 trial evaluating the combination of epcoritamab, a T-cell engaging bispecific antibody, and lenalidomide, compared to rituximab plus gemcitabine plus oxaliplatin (R-GemOx) in adult patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) who received at least 1 prior line of therapy. Based on topline results from the pre-specified primary analysis, the trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in Progression-Free Survival (PFS). The risk of disease progression and death was reduced by 60 percent (HR 0.40 [95 percent CI 0.30, 0.55]; p-value <0.0001) and 56 percent (HR 0.44 [95 percent CI 0.33, 0.60]; p-value <0.0001), based on different censoring rules in the US and outside the US, respectively.

The safety profile of epcoritamab when administered in combination with lenalidomide was consistent with the known safety profiles of the individual agents (epcoritamab and lenalidomide).

Daejin Abidoye, MD, Vice President (VP), Therapeutic Area Head, Oncology, Solid Tumor and Hematology, AbbVie, said, "Despite recent advances, there remains a critical need for innovative therapies to improve outcomes for those battling DLBCL, an aggressive and often difficult-to-treat cancer. Today's encouraging topline results highlight the potential of epcoritamab, a fixed-treatment therapy, in combination with lenalidomide, as a meaningful treatment option after initial disease progression."

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