Genmab’s bispecific antibody EPKINLY (epcoritamab‑bysp) achieved a 79% reduction in the risk of disease progression or death in the pivotal Phase 3 EPCORE FL‑1 trial, a result presented at the American Society of Hematology meeting on December 7, 2025. The study enrolled 243 patients in the EPKINLY + rituximab‑lenalidomide (R2) arm and 245 in the R2 alone arm, confirming the combination’s superiority over standard therapy.
In the combination arm, the overall response rate reached 95% and the complete response rate climbed to 83%, compared with 79% and 50% respectively for R2 alone. The 12‑month duration of response was 89% for EPKINLY + R2 versus 49% for R2, underscoring the durability of the benefit.
The trial’s hazard ratio of 0.21 translates to the reported 79% risk reduction, positioning EPKINLY as the first bispecific antibody‑based, chemotherapy‑free regimen to demonstrate superior clinical benefit in relapsed or refractory follicular lymphoma. Dr. Judith Klimovsky, Genmab’s Executive Vice President and Chief Development Officer, said the data “demonstrate the potential of epcoritamab to enable earlier intervention and deliver improved outcomes,” while lymphoma specialist Lorenzo Falchi noted that the combination “redefines the second‑line treatment landscape.”
The results support Genmab’s strategy to expand EPKINLY beyond its initial accelerated approval for monotherapy, which was converted to full approval on November 18, 2025. The FDA approval of the EPKINLY + R2 combination further expands the drug’s addressable market and could establish a new standard of care in the second‑line setting, offering patients a chemotherapy‑free option with robust efficacy.
The combination’s strong efficacy, coupled with its chemotherapy‑free profile, positions Genmab to capture a growing segment of follicular lymphoma patients seeking less toxic therapies. The data also reinforce the company’s broader pipeline of bispecific antibodies targeting B‑cell malignancies, potentially accelerating future approvals and commercial opportunities.
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