Genmab and AbbVie Announce Topline Results for EPKINLY + lenalidomide in R/R DLBCL


Genmab and AbbVie announced positive topline results from the Phase 3 EPCORE DLBCL-4 trial. The trial met its primary objective, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS) in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who received at least one prior line of treatment. The risk of disease progression and death was reduced by 60% (HR 0.40 [95% CI 0.30, 0.55]; p value < 0.0001) and 56% (HR 0.44 [95% CI 0.33, 0.60]; p value < 0.0001), based on different censoring rules in the U.S. and outside the U.S., respectively.

The trial evaluated epcoritamab in combination with lenalidomide, compared to rituximab plus gemcitabine plus oxaliplatin (R-GemOx). These results demonstrate epcoritamab’s potential to expand options for patients and solidify its role as a potential core therapy across B-cell malignancies.

Why this matters:

  • Data from the EPCORE DLBCL-4 trial adds to the growing evidence supporting the versatility of epcoritamab-based combinations across lines of therapy, including fixed-duration epcoritamab, for patients with R/R DLBCL who received at least one prior treatment.
  • DLBCL is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30% of all NHL cases. Although new therapies have become available, treatment management can remain a challenge.
  • The safety profile of epcoritamab when administered in combination with lenalidomide was consistent with the previously reported safety profile of the individual agents (epcoritamab or lenalidomide).