#United States #Epcoritamab #North Chicago #Rituximab #Lenalidomide

AbbVie's Epcoritamab (EPKINLY) Gains FDA Approval

AbbVie, a global biopharmaceutical company, recently announced that the U.S. Food and Drug Administration (FDA) has approved Epcoritamab (EPKINLY) in combination with rituximab and lenalidomide (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). This marks a significant advancement in the treatment of a complex and challenging disease.

Epcoritamab is a subcutaneously administered T-cell-engaging bispecific antibody. The approval of Epcoritamab plus R2 is groundbreaking as it is the first and only bispecific antibody-based combination therapy approved specifically for FL after one or more prior systemic therapies. According to the pivotal Phase 3 EPCORE FL-1 trial, the concurrent use of Epcoritamab with rituximab and lenalidomide significantly improved progression-free survival (PFS) and overall response rates (ORR) as compared to the standard R2 therapy. Remarkably, approximately three-quarters of the patients treated with Epcoritamab plus R2 achieved a complete response (CR).

Study Findings and Impact

The EPCORE FL-1 trial evaluated the efficacy and safety of Epcoritamab in patients with R/R FL who had received prior treatments. In this non-blinded, randomized trial, participants were randomly assigned to receive either the Epcoritamab combination treatment or the standard R2 therapy. Key results indicated that the combination therapy led to a 79% reduction in the risk of disease progression or death compared to R2 with a hazard ratio (HR) of 0.21. The ORR stood at 89% for the Epcoritamab group versus 74% for the R2 group (p < 0.0001). Moreover, the median PFS had not yet been reached for the Epcoritamab group, while it was 11.2 months for the R2 group, highlighting the potential of this new combination to alter the treatment landscape for FL.

Dr. Lorenzo Falchi, a lymphoma specialist at Memorial Sloan Kettering Cancer Center, emphasized the necessity for innovative treatments for relapsed follicular lymphoma, a condition that often proves difficult to cure. The impressive results from the EPCORE FL-1 study provide hope for changing the disease course earlier in treatment strategies.

Safety Profile

While the Epcoritamab combination therapy demonstrated significant efficacy, the safety profile was consistent with the known safety information for the individual components. Common adverse reactions observed (greater than 20%) included rash, upper respiratory infections, fatigue, injection site reactions, constipation, diarrhea, cytokine release syndrome (CRS), pneumonia, and fevers. The most frequent severe adverse reactions included neutropenia, lymphopenia, and thrombocytopenia. In total, 24% of patients experienced CRS; however, the majority of these were low grade.

Meghan Gutierrez, CEO of the Lymphoma Research Foundation, stated that this approval signifies a major milestone for patients suffering from follicular lymphoma, providing a treatment option that can potentially be administered in various clinical settings, thus improving patient access to care.

Future Directions

Epcoritamab received Breakthrough Therapy Designation from the FDA, affirming its potential to offer significant benefits over existing treatments based on preliminary clinical evidence. This designation is intended to expedite the development and review of drugs that have shown promising results for serious conditions.

Dr. Daejin Abidoye from AbbVie remarked that the approval allows Epcoritamab to be recognized as the first bispecific antibody for use in relapsed or refractory follicular lymphoma patients after secondary therapy. The promise of improving patient outcomes emphasizes the pressing need for effective treatment alternatives.

The data from the EPCORE FL-1 trial will be presented at the American Society of Hematology (ASH) annual meeting in December 2025, further expanding the insights into Epcoritamab's role in treating this challenging malignancy.

The study and development of Epcoritamab are part of AbbVie's ongoing commitment to revolutionizing treatment for a variety of blood cancers, reflecting a broader effort to address unmet medical needs in oncology.

Summary

Overall, the approval of Epcoritamab provides renewed hope for patients battling R/R follicular lymphoma. By implementing a pioneering treatment strategy that leverages the unique mechanisms of bispecific antibodies, AbbVie could redefine standard care practices and potentially enhance the survival and quality of life for patients facing this difficult-to-treat disease.