Genmab's Epcoritamab Combination Drug Cuts Risk of Disease Progression by 79% in Follicular Lymphoma Patients

Genmab's partnered blood cancer drug, epcoritamab, in combination with rituximab and lenalidomide, demonstrated a 79% reduction in the risk of disease progression or death in a Phase 3 trial for relapsed or refractory follicular lymphoma. The results will be presented at the American Society of Hematology annual meeting and serve as the basis for global regulatory submissions. The FDA has accepted the supplemental Biologics License Application for priority review, with a target action date of November 30, 2025.

Copenhagen-based biotechnology company Genmab has reported positive results from its Phase 3 EPCORE FL-1 trial, which evaluated the efficacy of epcoritamab, a bispecific antibody, in combination with rituximab and lenalidomide (R2) for treating adults with relapsed or refractory follicular lymphoma (FL) [1]. The trial achieved its dual primary endpoints, demonstrating significant improvements in overall response rate (ORR) and progression-free survival (PFS). The combination therapy showed a 79% reduction in the risk of disease progression or death compared to R2 alone [1].

The trial's success comes on the heels of the U.S. Food and Drug Administration (FDA) accepting a supplemental biologics license application (sBLA) for priority review of epcoritamab plus R2. The FDA has set a target decision date under the Prescription Drug User Fee Act (PDUFA) for November 30, 2025 [1]. If approved, this 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 has approvals in various lymphoma indications across several regions and is being co-developed with AbbVie [1]. 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 [1]. The FDA has granted 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 [2].

The results from this trial and the FDA's decision to accept the sBLA for priority review demonstrate the potential of this epcoritamab combination therapy to reshape the treatment landscape for B-cell malignancies [1]. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy and in combination across different lines of therapy in a range of hematologic malignancies [1].

References:
[1] https://www.worldpharmaceuticals.net/news/genmabs-phase-3-trial-of-epcoritamab-yields-positive-results-in-follicular-lymphoma/
[2] https://www.manilatimes.net/2025/08/07/tmt-newswire/globenewswire/genmab-announces-phase-3-epcore-fl-1-clinical-trial-met-dual-primary-endpoints-in-patients-with-relapsedrefractory-rr-follicular-lymphoma-fl/2164180