EPCORE FL-1 Results Show Significance of Epcoritamab Combo in Follicular Lymphoma

Updated results from the phase 3 EPCORE FL-1 trial (NCT05409066) assessing epcoritamab-bysp (Epkinly) plus rituximab (Rituxan) and lenalidomide (Revlimid) for patients with relapsed/refractory follicular lymphoma were recently announced.

The results showed the trial met the primary end point of overall response rate (P <.0001) and progression-free survival (HR, 0.21; P <.0001). The risk of disease progression or death was reduced by 79%. Additional presentation of these results is expected to be submitted to the American Society of Hematology for the 2025 Annual Meeting and Exposition.

The FDA has set a Prescription Drug User Fee Act Date of November 30, 2025. If this regimen is approved, it will become the first bispecific antibody combination available in the US as second-line therapy for this disease state.

Because of these new data, CancerNetwork® spoke with Julie M. Vose, MD, MBA, George and Peggy Payne Distinguished Chair of Oncology, chief of Oncology & Hematology, professor of Oncology & Hematology at the University of Nebraska Medical Center, and co-editor-in-chief of ONCOLOGY®. She highlighted why these results were so significant and how these data can be used long-term.

Transcript:

EPCORE FL-1 is a clinical trial using a bispecific antibody, [epcoritamab], and now has some long-term data. This information is shown in several different types of lymphoma; diffuse large B-cell, follicular lymphoma, and there is a bit of data in other types of B-cell lymphomas, but those are the 2 most common. What is important from this long-term data is that there are [many] patients who are staying on the treatment long-term and are able to tolerate it well. There are [numerous] patients who have this long-term data that are staying in remission off therapy, even though it has been stopped; it appears that the remissions are durable in a percentage of patients. This is important. It is a whole new class of drugs that have only been available for a short period of time, but these long-term data from the original clinical trials are showing us that it may have long-term benefits, even though the treatment has been stopped.

Reference

Genmab announces phase 3 EPCORE® FL-1 clinical trial met dual primary endpoints in patients with relapsed/refractory (R/R) follicular lymphoma (FL). News release. Genmab. August 7, 2025. Accessed August 12, 2025. https://tinyurl.com/4nhj3566