Genmab A/S (NASDAQ:GMAB) released results Thursday of the Phase 3 EPCORE FL-1 trial evaluating subcutaneous epcoritamab in combination with rituximab and lenalidomide (R2) versus R2 alone for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
The study met its dual primary endpoints of overall response rate (ORR) and progression-free survival (PFS), demonstrating statistically significant and clinically meaningful differences in both endpoints, reducing the risk of disease progression or death by 79%.
The company is developing the drug in partnership with AbbVie Inc.(NYSE:ABBV).
The results, derived from a pre-planned interim analysis, will be submitted for presentation at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) and will serve as the basis for global regulatory submissions.