Genmab has announced that its phase 3 EPCORE FL-1 trial met both primary endpoints in patients with relapsed or refractory follicular lymphoma.
The study evaluated epcoritamab, a bispecific antibody, in combination with rituximab and lenalidomide (R2) versus R2 alone.
The combination showed a statistically significant improvement in overall response rate (95.7%, p < 0.0001) and progression-free survival (HR 0.21, p < 0.0001), reducing the risk of disease progression or death by 79%. These findings will support global regulatory submissions.
The US FDA has accepted a supplemental Biologics License Application for priority review, with a target action date of 30 November 2025. If approved, epcoritamab plus R2 would become the first bispecific antibody combination regimen available as a second-line treatment for this patient group.
Jan van de Winkel, Chief Executive Officer of Genmab, said: “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.”
The safety profile of the combination was consistent with known data for the individual agents. No new safety signals were observed. Epcoritamab is already approved in the US as a monotherapy for adults with R/R FL after two or more systemic treatments.
Follicular lymphoma is a slow-growing form of non-Hodgkin’s lymphoma, accounting for up to 30 percent of cases. It is considered incurable with current therapies and often relapses.
Around 15,000 people are diagnosed annually in the US, and over 25 percent may progress to aggressive large B-cell lymphoma.
