Epcoritamab (Epkinly) Now FDA-Approved for Relapsed/Refractory Follicular Lymphoma

The bispecific antibody epcoritamab (Epkinly, Genmab) was FDA-approved on June 26, 2024, for the treatment of relapsed/refractory follicular lymphoma. The approval was granted based on findings from the EPCORE NHL​-1 study. 

Follicular lymphoma specialist Umberto Vitolo, M.D. from Candiolo Cancer Institute in Italy, shared insight with HealthTree at the EHA 2024 conference about epcoritamab’s impact on treating follicular lymphoma. 

Watch Dr. Vitolo’s interview and read more about the FDA approval of epcoritamab below. 

What is Epcoritamab? 

Epcoritamab is a bispecific antibody, sometimes called a T-cell engager. It works by attaching to the surface protein CD3 on cancer-killing T-cells and the surface protein CD20 on cancerous B-cells such as the ones found in follicular lymphoma, bringing the two near each other. This helps the T-cells recognize and kill cancer cells. 

Epcoritamab was first FDA-approved for diffuse large B-cell lymphoma (DLBCL). Thanks to data from phase 1/2 of the EPCORE NHL​-1 FL study, epcoritamab is now also FDA-approved for follicular lymphoma patients whose disease returned or became intolerant to prior lines of therapy (relapsed/refractory). Epcoritamab has also received a positive recommendation from the CHMP (Committee for Medicinal Products for Human Use) in Europe. 

Most bispecific antibodies are administered as an intravenous infusion (IV). Epcoritamab, however, is administered as a shot under the skin in step-up doses (patients receive small doses first, then gradually work up to the recommended dose). The monthly shots are given indefinitely until follicular lymphoma cells become intolerant to the treatment. 

Image source: Epkinly

How Effective is Epcoritamab for Relapsed/Refractory Follicular Lymphoma? 

The data from phase 1/2 of the EPCORE NHL​-1 FL study found the following regarding how well epcoritamab worked for patients with relapsed/refractory follicular lymphoma: 

• 82% of patients had a reduction of disease signs and symptoms. 
• 66% of patients achieved minimal residual disease negativity (a highly sensitive test that can detect very small numbers of cancer cells in the blood.) 
• The majority of side effects were mild-moderate and manageable. Common side effects included cytokine release syndrome (CRS), injection-site reactions, COVID-19, fatigue, decreased neutrophils, diarrhea, and fever.  

“With this approval, patients whose follicular lymphoma has relapsed or is refractory to at least two or more lines of systemic therapy, now have the option to be treated with EPKINLY, which has demonstrated durable responses without mandatory hospitalization using a 3 step-up dosage regimen in this patient population in clinical trials. In just over a year, EPKINLY has received a second indication in the U.S., making it the first and only bispecific antibody approved to treat patients with diffuse large B-cell lymphoma and follicular lymphoma after two or more lines of systemic therapy. The approved indications, along with the ongoing clinical development program, underscore the potential of epcoritamab to become a core therapy across B-cell malignancies.” Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab

The early data from the EPCORE NHL​-1 FL study proved to make a strong enough case for the FDA to grant approval of epcoritamab’s use in relapsed/refractory follicular lymphoma. Additional clinical trials with epcoritamab are exploring the combination with other commonly used medicines for follicular lymphoma, such as rituximab or lenalidomide. HealthTree looks forward to continued research that develops from these studies. 

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Sources: 

• Epcoritamab has shown to produce significant responses in patients with relapsed or refractory follicular lymphoma, according to safety and pooled efficacy data from EPCORE NHL-1 pivotal and Cycle 1 Optimization (OPT) FL cohorts
• The End of the Indolence: When Should You Change Treatment Strategy in Relapsed/Refractory (R/R) Follicular Lymphoma (FL)? - Session 
• Epkinly
• FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma
• EPKINLY® (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)