Genmab's Epcoritamab BLA

The decision to submit the sBLA is supported by positive topline results from the Phase III  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.

 EPCORE FL-1 (NCT05409066) is an ongoing  Phase III open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R²) versus R² alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The dual primary endpoints are ORR and progression-free survival assessed by independent review committee (IRC) per Lugano criteria.

“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 Dr. Jan van de Winkel,  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.”