Business
Genmab Presents Pivotal Phase 3 Data from EPCORE® FL-1 Trial Demonstrating Clinical Benefit of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide (R2) in Patients with Relapsed or Refractory Follicular Lymphoma
Media ReleaseCOPENHAGEN, Denmark; December 7, 2025 Trial demonstrated treatment with fixed duration EPKINLY plus rituximab and lenalidomide (EPKINLY+ R2) resulted in statistically significant and clinically meaningful reduction in the risk of disease progression or death and overall response compared to R2 aloneEPKINLY + R2 was recently approved by the U.S. Food and Drug Administration as the first and only bispecific-based therapy for follicular lymphoma in the second-line settingResults of EPC
About this update from Genmab A/s
[{"type":"image","alt":"Genmab A/S","displaySize":"","headline":null,"caption":"Genmab A/S","className":"","disableSlideshowImg":false,"size":{"original":{"width":275,"height":85,"url":"https://media.zenfs.com/en/globenewswire.com/c0cd563151331363bc069dc3ced1531d"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/3fXMaEmkURmdIw8oGLJV.g--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEzMDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/c0cd563151331363bc069dc3ced1531d","width":275,"height":85}},"lazy":false},{"type":"text","content":"Media ReleaseCOPENHAGEN, Denmark; December 7, 2025","length":52,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Trial demonstrated treatment with fixed duration EPKINLY plus rituximab and lenalidomide (EPKINLY+ R2) resulted in statistically significant and clinically meaningful reduction in the risk of disease progression or death and overall response compared to R2 alone","length":267,"tagName":"p"}]},{"val":[{"type":"text","content":"EPKINLY + R2 was recently approved by the U.S. Food and Drug Administration as the first and only bispecific-based therapy for follicular lymphoma in the second-line setting","length":173,"tagName":"p"}]},{"val":[{"type":"text","content":"Results of EPCORE FL-1 simultaneously published in The Lancet","length":61,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":501,"olType":false},{"type":"text","content":"Genmab A/S (Nasdaq: GMAB) today announced primary data from the pivotal Phase 3 EPCORE® FL-1 study evaluating fixed duration EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The study showed that treatment with EPKINLY + R2 reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.14-0.31, p<0.0001) compared to standard of care R2. Additionally, the overall response rate (ORR) in patients treated with EPKINLY + R2 was 95% (95% CI: 91.5, 97.4) compared to 79% in patients treated with R2 (95% CI: 73.6, 84.1; P<.0001). The EPCORE FL-1 study results were presented during an oral presentation (abstract 466) 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 ...