Genmab has reported successful outcomes from its Phase 3 EPCORE FL-1 trial, which evaluated the efficacy of epcoritamab for treating adults with relapsed or refractory follicular lymphoma (FL).
Epcoritamab, which is a bispecific antibody, was evaluated in combination with rituximab and lenalidomide (R2) compared to treatment with R2 alone.
The trial achieved its dual primary objectives, delivering significant improvements in overall response rate (ORR) and progression-free survival (PFS). It also showed a 79% reduction in the risk of disease progression or death.
Genmab CEO Jan van de Winkel said: “While therapeutic options exist for patients with relapsed or refractory follicular lymphoma, response rates tend to decline and durability diminishes with each subsequent line of treatment, which can increase the risk of the disease transforming into aggressive large-cell lymphoma.
“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 and reinforces our shared commitment with AbbVie to advance epcoritamab as a potential core therapy across B-cell malignancies.”
Last month, the US Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) for priority review of epcoritamab. This application is for the use of the bispecific antibody plus R2 following one prior systemic therapy, based on initial analysis data showing significant gains in ORR and PFS.
The FDA has set a target decision date under the Prescription Drug User Fee Act (PDUFA) for 30 November 2025. Approval would mark the first availability of this bispecific antibody combination as a second-line treatment for R/R FL in the US.
Epcoritamab, developed using Genmab’s DuoBody technology, targets CD3 on T cells and CD20 on B cells to stimulate immune responses against these cell types. The drug, marketed as EPKINLY in the US and Japan and TEPKINLY in Europe, has approvals in various lymphoma indications across several regions.
Co-developed with AbbVie under a collaboration that began in June 2020, Genmab received an upfront payment of $750m from AbbVie, with potential milestone payments reaching $3.15bn.
Both companies share commercial responsibilities in the US and Japan, while AbbVie leads global commercialisation efforts. They are pursuing additional regulatory approvals for both R/R FL and R/R DLBCL indications.
Genmab and AbbVie are conducting ongoing trials to assess epcoritamab’s effectiveness across different lines of therapy in haematologic cancers. The safety profile of epcoritamab combined with R2 aligns with existing safety data of these treatments without revealing new safety concerns.
