Genmab said the European Commission cleared the chemotherapy-free regimen after EPCORE FL-1 showed a 79% reduction in risk of progression or death versus R2 alone.
Genmab said the European Commission granted marketing authorization for TEPKINLY (epcoritamab) with lenalidomide and rituximab, or R2, for adult patients with relapsed or refractory follicular lymphoma. The company described it as the first and only bispecific-based therapy approved in Europe for this disease in the second-line setting and a chemotherapy-free option. The approval was backed by the Phase 3 EPCORE FL-1 trial, which compared fixed-duration TEPKINLY plus R2 with standard-of-care R2 and showed a 79% reduction in the risk of disease progression or death, with a hazard ratio of 0.21 and p<0.0001. Overall response rate reached 96% versus 81%, while complete response was 74% versus 43%. Genmab said the most common adverse reactions included neutropenia, rash, upper respiratory tract infections, fatigue, diarrhea, injection site reactions, anemia, constipation, thrombocytopenia, cytokine release syndrome, hypogammaglobulinemia, COVID-19, pyrexia, and pneumonia.