Genmab's Epcoritamab Combo Shows Improved Response Rate in Follicular Lymphoma Trial

Genmab's Phase 3 EPCORE FL-1 trial has reported positive results for the bispecific antibody epcoritamab in combination with rituximab and lenalidomide (R2) for relapsed/refractory Follicular Lymphoma (FL). The combination demonstrated significant improvement in Overall Response Rate (ORR) and Progression-Free Survival (PFS) compared to R2 alone. The FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) for epcoritamab plus R2, with an action date of November 30, 2025. If approved, this would be the first bispecific antibody combination regimen for second-line treatment of R/R FL.

Title: Genmab's EPCORE FL-1 Trial Demonstrates Positive Results for Epcoritamab Combination Therapy in Follicular Lymphoma

Genmab A/S (Nasdaq: GMAB) has announced positive results from its Phase 3 EPCORE FL-1 trial, evaluating the bispecific antibody epcoritamab in combination with rituximab and lenalidomide (R2) for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL). The trial met its primary endpoints of Overall Response Rate (ORR) and Progression-Free Survival (PFS), demonstrating statistically significant improvements over R2 alone [1].

The ORR for the combination therapy was 95.7%, with a p-value of 0.0001, compared to 23.5% for R2 alone. The PFS hazard ratio (HR) was 0.21, with a p-value of 0.0001, indicating a 79% reduction in the risk of disease progression or death [1]. 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) [1].

Separately, 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 an action date of November 30, 2025. If approved, this would be the first bispecific antibody combination regimen available in the U.S. as a second-line treatment option for patients with R/R FL [1].

Genmab's Chief Executive Officer, Jan van de Winkel, Ph.D., commented on the results, stating, "The results from this trial, and the decision from the FDA to accept the sBLA for priority review, demonstrate the potential of this epcoritamab combination therapy to reshape the treatment landscape and reinforce our shared commitment with AbbVie to advance epcoritamab as a potential core therapy across B-cell malignancies" [1].

The safety profile of epcoritamab in combination with R2 was consistent with the known safety profiles of the individual regimens and as presented in the U.S. prescribing information for epcoritamab. No new safety signals were observed [2].

Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and is administered subcutaneously. It is designed to simultaneously bind to CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20+ cells [2]. Epcoritamab has received regulatory approval in certain lymphoma indications in several territories [2].

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy and in combination across various lines of therapy in a range of hematologic malignancies [2]. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization [2].

References:
[1] https://uk.finance.yahoo.com/news/genmab-announces-phase-3-epcore-143000851.html
[2] https://finance.yahoo.com/news/genmab-announces-phase-3-epcore-143000789.html