FDA approves EPKINLY® for relapsed or refractory follicular lymphoma

June 26, 2024, marked a milestone for patients suffering from follicular lymphoma. The FDA approved Genmab’s epcoritamab-bysp (EPKINLY®) for relapsed or refractory follicular lymphoma.

Epcoritamab is an IgG1-bispecific antibody. It works by binding to both CD3 on T cells and CD20 on B cells. This binding triggers T cells to kill CD20-positive cells, a key aspect of combating the cancer. Notably, epcoritamab has already been approved for certain lymphoma indications. Genmab and AbbVie collaboratively developed the drug as part of their ongoing oncology partnership.

Making a First: Subcutaneous T-Cell Engaging Therapy

This approval marks a milestone, EPKINLY becomes the first and only T-cell engaging bispecific antibody administered subcutaneously to be approved in the United States for treating relapsed or refractory follicular lymphoma. The FDA granted accelerated approval based on the drug’s positive response rate.

Understanding Follicular Lymphoma

Follicular lymphoma is the most common type of non-Hodgkin’s lymphoma (NHL), accounting for roughly 20-30% of all NHL cases. Unfortunately, standard therapy cannot cure the disease, and patients often experience relapse.

Clinical Trial Results Paved the Way

The approval was based on the results of the phase 1/2 EPCORE® NHL-1 clinical trial. This trial assessed the safety and initial efficacy of EPKINLY in 127 adult patients with relapsed or refractory follicular lymphoma (R/R FL). These patients had previously received an average of three lines of therapy. The results were promising:

• An overall response rate (ORR) of 82%
• A complete response (CR) rate of 60%
• Notably, 67% of responding patients achieved minimal residual disease (MRD) negativity, indicating very low tumor burden.
• Also, over half of the patients who responded to treatment maintained that response when the data was analyzed.

These findings were recently published in the Lancet Haematology journal.

A New Option for Treatment

The approval of EPKINLY provides renewed hope for patients battling follicular lymphoma. It offers a readily available T-cell engaging treatment option that addresses a critical need in this area.

Looking Ahead: Continued Research

Genmab and AbbVie are actively exploring the use of Epcoritamab further. This includes both monotherapy and combination therapy applications for various hematological cancers. Four ongoing Phase 3 open-label, randomized trials are currently underway, targeting relapsed and refractory diffuse large B-cell lymphoma, newly diagnosed DLBCL, and combination therapy for relapsed and refractory follicular lymphoma.