August 7, 2025 — Genmab A/S (Nasdaq: GMAB) announced positive results from the Phase 3 EPCORE® FL-1 trial, where epcoritamab in combination with rituximab and lenalidomide (R2) demonstrated a statistically significant improvement in Overall Response Rate (ORR; 95.7%, p < 0.0001) and Progression-Free Survival (HR 0.21, p-value <0.0001) versus R2 alone in patients with relapsed/refractory (R/R) Follicular Lymphoma (FL). These results will form the basis for global regulatory submissions.
The U.S. FDA has accepted for priority review the new supplemental Biologics License Application (sBLA) for epcoritamab plus R2, with an action date of November 30, 2025. If approved, it would be the first bispecific antibody combination regimen available as a second-line treatment option for patients with R/R FL.
According to Genmab, the safety profile of epcoritamab in combination with R2 was consistent with the known safety profiles of the individual regimens. The U.S. FDA previously 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 the second most common form of non-Hodgkin’s lymphoma (NHL). Approximately 15,000 people develop FL each year in the U.S., and it is considered incurable with current standard of care therapies.
Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs, T: +1 609 955 2392, E: mmp@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations, T: +45 3377 9558, E: acn@genmab.com
Source: Genmab
