Genmab's Phase 3 EPCORE FL-1 study with epcoritamab achieves primary endpoints in follicular lymphoma treatment, FDA grants priority review for potential approval as a second-line treatment.

Genmab's Phase 3 EPCORE FL-1 study demonstrates significant improvement in overall response rate (95.7%) and progression-free survival (hazard ratio 0.21) in patients with relapsed or refractory follicular lymphoma. The study has met both primary efficacy endpoints and the FDA has granted the application priority review, with a decision date set for November 30. If approved, epcoritamab in combination with rituximab and lenalidomide (R2) would be the first bispecific antibody combination available as a second-line treatment for this disease.

Genmab A/S (Nasdaq: GMAB) has announced positive results from its Phase 3 EPCORE FL-1 trial, which evaluated the safety and efficacy of epcoritamab in combination with rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed or refractory (R/R) follicular lymphoma (FL). The study met its dual primary endpoints of overall response rate (ORR) and progression-free survival (PFS), demonstrating statistically significant improvements.

The ORR for the epcoritamab plus R2 combination was 95.7%, compared to 49.9% for R2 alone (p 0.0001). The hazard ratio for PFS was 0.21 (p-value 0.0001), indicating a 79% reduction in the risk of disease progression or death. These results were derived from a pre-planned interim analysis and will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH).

The U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) for epcoritamab plus R2, with a target action date of November 30, 2025. If approved, this would be the first bispecific antibody combination regimen available as a second-line treatment option for patients with R/R FL in the U.S.

Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology, designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. It is being co-developed by Genmab and AbbVie as part of their oncology collaboration.

The trial, EPCORE FL-1 (NCT05409066), is part of a broader effort by Genmab and AbbVie to evaluate the use of epcoritamab across various lines of therapy and hematologic malignancies. The safety and efficacy of epcoritamab in combination with R2 in R/R FL is currently being evaluated in clinical trials and is not yet approved or established in the U.S., EU, or any other territory.

References:
[1] https://www.businesswire.com/news/home/20250807189955/en/Genmab-Announces-Phase-3-EPCORE-FL-1-Clinical-Trial-Met-Dual-Primary-Endpoints-in-Patients-with-RelapsedRefractory-RR-Follicular-Lymphoma-FL