Genmab A/S (Nasdaq: GMAB) announced its intention to submit in the first half of 2025 a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab, a bispecific antibody being investigated in combination with rituximab and lenalidomide (R²) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), following at least one prior systemic therapy.

The decision to submit the sBLA is supported by positive topline results from the Phase 3 EPCORE FL-1 trial evaluating epcoritamab plus R² versus R² alone in adult patients with R/R FL. Based on an interim analysis conducted by an Independent Data Monitoring Committee (IDMC) review, the study met one of its dual primary endpoints of ORR (Complete Response plus Partial Response, p-value < 0.0001). The safety profile of epcoritamab plus R² in adult patients with R/R FL was consistent with the known safety profiles of the individual regimens (epcoritamab and R²) and as presented in the U.S. prescribing information for epcoritamab. No new safety signals were observed. The full results will be submitted later this year for presentation at an upcoming medical congress and discussed with global regulatory authorities.

“We are pleased with the strength of the data that allows us to submit a supplemental Biologics License Application in accordance with the U.S. FDA’s Project Frontrunner, which supports our commitment to advance novel medicines to patients who need them. The interim topline results demonstrate the potential of this investigational epcoritamab combination regimen to treat relapsed or refractory follicular lymphoma patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. “This milestone represents our commitment to the ongoing development of epcoritamab, with our partner AbbVie, and we look forward to seeing the full results from the study.”

Use of epcoritamab plus R² in R/R FL is not approved in the U.S., in the EU or in any other territory. The safety and efficacy of epcoritamab for use as a combination therapy in FL have not been established. Epcoritamab is currently approved by the FDA under Accelerated Approval as a monotherapy for the treatment of adults with R/R FL after two or more lines of systemic therapy.