Genmab Announces Positive Phase 3 EPCORE FL-1 Trial Results for Epcoritamab in R/R Follicular Lymphoma

Thursday, Aug 7, 2025 10:32 am ET1min read

Genmab's Phase 3 EPCORE FL-1 trial met dual primary endpoints for relapsed/refractory follicular lymphoma (FL), demonstrating a 95.7% overall response rate and a 79% reduction in progression-free survival. The results will serve as the basis for global regulatory submissions. The US FDA has accepted the supplemental Biologics License Application for priority review, with a target action date of November 30, 2025. If approved, epcoritamab plus rituximab and lenalidomide would be the first bispecific antibody combination regimen available for second-line treatment in R/R FL.

Genmab Announces Positive Phase 3 EPCORE FL-1 Trial Results for Epcoritamab in R/R Follicular Lymphoma

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