AbbVie says Phase 3 EPCORE DLBCL-4 met primary endpoint in DLBCL

AbbVie and Genmab said epcoritamab plus lenalidomide improved progression-free survival versus R-GemOx in relapsed or refractory DLBCL; Genmab shares rose 6% in European trading while the companies prepare regulatory discussions.

Summary

AbbVie and Genmab said the Phase 3 EPCORE DLBCL-4 trial met its primary endpoint in adults with relapsed or refractory diffuse large B-cell lymphoma after at least one prior line of therapy. Topline data showed epcoritamab plus lenalidomide delivered a statistically significant and clinically meaningful improvement in progression-free survival versus rituximab, gemcitabine and oxaliplatin, reducing the risk of disease progression or death by 60% under U.S. censoring rules and 56% outside the U.S. Genmab shares rose 6% in European morning trading after the update, while AbbVie was little changed in U.S. premarket trading. The companies said they plan to discuss next steps with global regulators and submit the data for presentation at a future medical meeting.

Terms & Concepts
  • bispecific antibody: Engineered antibody that binds two targets
  • progression-free survival: Time patients live without disease worsening
  • hazard ratio: Measure comparing event risk between groups