- Genmab A/S (GMAB, Financial) will submit a supplemental Biologics License Application (sBLA) to the FDA for its drug combination, targeting relapsed/refractory follicular lymphoma.
- The decision follows positive interim results from the Phase 3 EPCORE FL-1 trial showing a significant overall response rate.
- The full trial results will be presented at a medical conference in 2025.
Genmab A/S (GMAB) has announced plans to submit a supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration (FDA) in the first half of 2025. This submission will focus on the use of its bispecific antibody, epcoritamab, combined with rituximab and lenalidomide (R²), for adult patients with relapsed or refractory follicular lymphoma (FL) who have undergone at least one prior systemic therapy.
The decision to proceed with the sBLA is based on promising interim results from the Phase 3 EPCORE FL-1 trial. This trial demonstrated a significant overall response rate (ORR), one of its dual primary endpoints, with a p-value of less than 0.0001. The Independent Data Monitoring Committee (IDMC) conducted the interim analysis, which supported the safety profile of the drug combination consistent with existing treatments, without new safety signals.
Genmab's CEO, Jan van de Winkel, Ph.D., emphasized the importance of these findings, stating that the data reinforces the potential of this investigational regimen to address the needs of patients with relapsed or refractory follicular lymphoma. The full results of the trial are expected to be shared at a forthcoming medical conference later in the year.
Currently, neither epcoritamab in combination with R² nor as a monotherapy for this indication is approved in the U.S. or other territories. The drug is co-developed with AbbVie as part of an extensive oncology collaboration aiming to expand its application across various hematologic malignancies.
