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 Release

COPENHAGEN, 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 alone
• 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
• Results of EPCORE FL-1 simultaneously published in The Lancet
  

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 67^th 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.

“Patients with relapsed or refractory follicular lymphoma have historically had limited treatment options,” said Lorenzo Falchi, M.D., Lymphoma Specialist, Department of Medicine, Memorial Sloan Kettering Cancer Center. “The EPCORE FL-1 results demonstrate that epcoritamab plus R² is the first bispecific antibody-based, chemotherapy-free combination to show superior clinical benefit over standard of care in a Phase 3 trial, underscoring its potential to redefine the second-line treatment landscape for follicular lymphoma.”

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 (median follow-up, 14.8 months), 83% achieved a complete response (CR) (n=201/243, 95% CI: 77.4, 87.3) compared to a 50% CR rate among patients treated with R² (n=122/245, 95% CI: 43.4, 56.2). The 12-month duration of response (DOR) was 89% (95% CI: 83.6, 93.0) versus 49% (95% CI: 38.8, 57.5) for patients treated with EPKINLY + R² and R², respectively.