Genmab A/S (GMAB) announced primary results 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 trial demonstrated that treatment with EPKINLY + R2 led to a statistically significant and clinically meaningful reduction in the risk of disease progression or death, lowering the risk by 79% compared to standard-of-care R2. The combination also achieved an overall response rate (ORR) of 95%, versus 79% in patients treated with R2 alone.
EPKINLY + R2 was recently approved by the U.S. Food and Drug Administration as the first and only bispecific antibody-based therapy for follicular lymphoma in the second-line setting.
The EPCORE FL-1 results were presented in an oral session (abstract 466) at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The data were also highlighted in the ASH press briefing on "Emerging Therapies and Immunotherapies in Blood Cancers" and simultaneously published in The Lancet.
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