Genmab A/S has shared new results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating epcoritamab, a T-cell engaging bispecific antibody, in combination with lenalidomide and rituximab (R2) for treating relapsed or refractory (R/R) follicular lymphoma (FL). The study demonstrated an impressive 96% overall response rate (ORR) and 87% complete response (CR) rate in 111 patients after two years of follow-up. The estimated progression-free survival (PFS) rate was 80%, with a two-year overall survival (OS) rate of 90%. The findings were presented at the 66th Annual Meeting of the American Society of Hematology (ASH).
“Follicular lymphoma is often incurable, and patients with relapsed or refractory cases need more treatment options,” said Dr. Lorenzo Falchi from Memorial Sloan Kettering Cancer Center. “These durable responses support further investigation of epcoritamab combined with rituximab and lenalidomide.”
Additional data showed that 89% of complete responders remained in CR at 18 months. Although COVID-19 affected 57% of patients during the trial, leading to discontinuation in 13%, the therapy was generally well tolerated. Neutropenia and cytokine release syndrome (CRS) were common treatment-emergent adverse events, but CRS cases were mainly mild and resolved without treatment discontinuation.
“These long-term results for epcoritamab are very encouraging for those with R/R follicular lymphoma,” said Dr. Judith Klimovsky, Executive Vice President & Chief Development Officer at Genmab. “This data reinforces epcoritamab’s potential as a core therapy for B-cell malignancies.”
Epcoritamab has received breakthrough therapy designation (BTD) from the FDA for R/R FL treatment and is currently being studied in the Phase 3 EPCORE FL-1 trial. Epcoritamab plus R2 for R/R FL is not yet approved in the U.S. or EU.
About Follicular Lymphoma (FL)
FL is a slow-growing non-Hodgkin’s lymphoma (NHL) that accounts for 20-30% of NHL cases. It remains incurable with standard therapies, and relapses often occur, with each recurrence leading to shorter remissions and time to next treatment. Some patients may also develop diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL.
About the EPCORE® NHL-2 Trial
This Phase 1b/2 trial is investigating epcoritamab as a monotherapy and in combination with other treatments in patients with B-cell NHL, including R/R FL.
About Epcoritamab
Epcoritamab is a bispecific antibody that targets CD3 on T cells and CD20 on B cells to induce T-cell-mediated destruction of CD20+ cells. It is co-developed by Genmab and AbbVie for use in various lymphoma indications and is approved in certain regions under the names EPKINLY® and TEPKINLY®.
