Genmab's Epcoritamab Combination Drug Cuts Risk of Disease Progression by 79% in Follicular Lymphoma Patients

Genmab's partnered blood cancer drug, epcoritamab, in combination with rituximab and lenalidomide, demonstrated a 79% reduction in the risk of disease progression or death in a Phase 3 trial for relapsed or refractory follicular lymphoma. The results will be presented at the American Society of Hematology annual meeting and serve as the basis for global regulatory submissions. The FDA has accepted the supplemental Biologics License Application for priority review, with a target action date of November 30, 2025.

Genmab A/S (Nasdaq: GMAB) has announced positive results from its Phase 3 EPCORE FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) versus R2 alone for the treatment of adult 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 and clinically meaningful differences.

The ORR was 95.7%, with a p-value of 0.0001, and the hazard ratio (HR) for PFS was 0.21, with a p-value of 0.0001. These results indicate a 79% reduction in the risk of disease progression or death. The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2, with a target action date of November 30, 2025. If approved, epcoritamab plus R2 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.

The safety profile of epcoritamab in combination with R2 was consistent with the known safety profiles of the individual regimens, and no new safety signals were observed. The U.S. FDA has granted accelerated approval of single agent epcoritamab for the treatment of adults with R/R FL after two or more lines of systemic therapy and Breakthrough Therapy Designation (BTD) to epcoritamab in combination with R2 for the treatment of adult patients with R/R FL who have received at least one prior line of therapy.

Follicular lymphoma (FL) is typically an indolent form of non-Hodgkin's lymphoma (NHL) that arises from B-lymphocytes. It is the second most common form of NHL, accounting for 20-30 percent of all cases. Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and 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.

Genmab and AbbVie are co-developing epcoritamab, with commercial responsibilities shared in the U.S. and Japan, and AbbVie responsible for further global commercialization. The companies continue to evaluate the use of epcoritamab as a monotherapy and in combination across lines of therapy in a range of hematologic malignancies.

The results from this trial and the FDA's decision to accept the sBLA for priority review demonstrate the potential of this epcoritamab combination therapy to reshape the treatment landscape for patients with R/R FL.

References:
[1] https://ir.genmab.com/news-releases/news-release-details/genmab-announces-phase-3-epcorer-fl-1-clinical-trial-met-dual