Genmab announces primary data from Phase 3 EPCORE FL-1 study

Genmab (GMAB) announced primary data from the pivotal Phase 3 EPCORE FL-1 study evaluating fixed duration EPKINLY in combination with rituximab and lenalidomide in adult patients with relapsed or refractory follicular lymphoma. The study showed that treatment with EPKINLY + R2 reduced the risk of disease progression or death by 79% compared to standard of care R2. Additionally, the overall response rate, ORR, in patients treated with EPKINLY + R2 was 95% compared to 79% in patients treated with R2. The EPCORE FL-1 study results were presented during an oral presentation at the 67th Annual Meeting and Exposition of the American Society of Hematology, ASH, in Orlando, Florida, featured in the “Emerging Therapies and Immunotherapies in Blood Cancers” ASH press briefing, and have been simultaneously published in The Lancet. The EPCORE FL-1 study included patients with R/R FL following at least one prior line of treatment across a broad range of patient characteristics and disease risk factors. Among patients who were treated with EPKINLY + R2 at the second planned interim analysis, 83% achieved a complete response compared to a 50% CR rate among patients treated with R2. The 12-month duration of response was 89% versus 49% for patients treated with EPKINLY + R2 and R2, respectively.