Genmab's Phase 3 Trial Shows EPKINLY + R2 Benefits in Relapsed Follicular Lymphoma
- EPKINLY + R2 reduced disease progression risk by 79% compared to R2 alone.
- The overall response rate for EPKINLY + R2 was 95% versus 79% for R2.
- FDA approved EPKINLY + R2 for relapsed follicular lymphoma in November 2025.
- Grade 3 or 4 adverse events were higher in EPKINLY + R2 at 90.1% compared to 67.6% for R2.
Study Overview
The EPCORE FL-1 Phase 3 trial evaluated the efficacy of EPKINLY (epcoritamab-bysp) combined with rituximab and lenalidomide (R2) in patients with relapsed or refractory follicular lymphoma. The study demonstrated a 79% reduction in the risk of disease progression or death compared to R2 alone.
Clinical Results
The overall response rate for patients treated with EPKINLY + R2 was 95%, significantly higher than the 79% response rate for those receiving R2 alone. Additionally, 83% of patients achieved a complete response with EPKINLY + R2, compared to 50% with R2.
Regulatory Approval
In November 2025, the U.S. Food and Drug Administration approved EPKINLY + R2 as a second-line treatment for relapsed or refractory follicular lymphoma, marking it as the first bispecific-based therapy in this setting.
Safety Profile
The safety profile of EPKINLY + R2 was consistent with known profiles of the individual regimens. Grade 3 or 4 treatment-emergent adverse events were reported in 90.1% of patients treated with EPKINLY + R2, compared to 67.6% for R2 alone. The higher rates were primarily due to increased neutropenia and infections.
Source: Genmab