Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE FL-1 trial for subcutaneous epcoritamab in combination with rituximab and lenalidomide, showing significant improvements in overall response rate (ORR) and progression-free survival (PFS) for patients with relapsed or refractory follicular lymphoma [2][6][4] - The U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for epcoritamab plus rituximab, with a target action date of November 30, 2025, which could make it the first bispecific antibody combination available in the U.S. for second-line treatment of this condition [3][6] - Epcoritamab is designed to target CD3 on T cells and CD20 on B cells, facilitating T-cell-mediated killing of malignant B cells, and has received regulatory approval in various lymphoma indications [8][9] Trial Results - The EPCORE FL-1 trial met its dual primary endpoints, achieving an ORR of 95.7% (p-value < 0.0001) and a PFS hazard ratio of 0.21 (p-value < 0.0001), indicating a 79% reduction in the risk of disease progression or death [2][6][4] - The safety profile of epcoritamab in combination with rituximab was consistent with known safety profiles, with no new safety signals observed [4][6] Industry Context - Follicular lymphoma (FL) is a slow-growing form of non-Hodgkin's lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new cases annually in the U.S. [5] - Current treatment options for R/R FL often lead to declining response rates and shorter remission periods, with over 25% of patients potentially transforming to aggressive large-cell lymphoma [5][4] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics, with a vision to transform cancer treatment by 2030 [11][12] - The company is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, while pursuing additional international regulatory approvals [9][10]