Danish biotechnology company Genmab A/S (CPH:GMAB) said on Friday that it plans to submit a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) in the first half of 2025 for subcutaneous epcoritamab combined with rituximab and lenalidomide (R2) in adult patients with relapsed or refractory follicular lymphoma after at least one prior systemic therapy.

This decision follows positive topline results from the Phase 3 EPCORE FL-1 trial, which met one of its dual primary endpoints by demonstrating a statistically significant overall response rate (p-value < 0.0001) in patients treated with epcoritamab plus R2 compared to R2 alone.

An interim analysis was conducted by an Independent Data Monitoring Committee, which found the safety profile of the combination consistent with known data for each therapy and no new safety signals.

Full trial results will be submitted for presentation at a medical conference later in 2025 and shared with regulatory authorities.

Epcoritamab in combination with R2 is not currently approved in the United States, the European Union or any other region. Epcoritamab is approved in the United States as a monotherapy for adults with relapsed or refractory follicular lymphoma after at least two prior systemic therapies.