Overview
- The agency approved epcoritamab-bysp with rituximab and lenalidomide for relapsed or refractory follicular lymphoma and granted traditional approval to epcoritamab monotherapy after at least two prior lines of therapy.
- In a preplanned interim analysis of EPCORE FL-1, the triplet achieved a hazard ratio for progression or death of 0.21, with median progression-free survival not reached versus 11.2 months for control.
- The overall response rate reached 89% with the epcoritamab regimen compared with 74% for rituximab plus lenalidomide alone, meeting the trial’s coprimary efficacy endpoints.
- Safety findings matched the known profiles of the component drugs, with boxed warnings for cytokine release syndrome and ICANS; cytokine release syndrome occurred in 24% and ICANS in 0.8%, while serious infections occurred in 28% of patients receiving the triplet.
- Genmab and AbbVie said additional EPCORE FL-1 results will be presented at the 2025 ASH Annual Meeting.