Thursday, June 27, 2024
Genmab A/S (Nasdaq: GMAB) has received approval from the U.S. Food and Drug Administration (FDA) for EPKINLY® (epcoritamab-bysp) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more prior systemic therapies. This marks EPKINLY as the first subcutaneously administered T-cell engaging bispecific antibody approved in the U.S. for this patient group under accelerated approval based on response rates. Continued approval will hinge on further verification of clinical benefits in subsequent trials.
Follicular lymphoma, the second most prevalent form of non-Hodgkin’s lymphoma (NHL), affects approximately 15,000 individuals annually in the U.S. FL is currently incurable with existing treatments, often leading to relapses and shorter response durations with each successive treatment regimen.
The FDA's decision is supported by data from the phase 1/2 EPCORE® NHL-1 trial involving 127 adults with R/R FL. Results demonstrated an overall response rate (ORR) of 82%, with 60% achieving complete response (CR) and 67% achieving minimal residual disease negativity. Notably, responses were durable, with over half of responders maintaining their response at a median follow-up of 14.8 months.
Common treatment-related adverse events (AEs) included injection site reactions, cytokine release syndrome (CRS), fatigue, and infections. CRS, managed through a step-up dosing regimen, was primarily low-grade, with no grade 3 events observed.
The approval of EPKINLY expands the treatment options available for patients with challenging FL cases, offering potential benefits without requiring hospitalization. Ongoing trials are assessing EPKINLY’s efficacy across various hematologic malignancies.
In terms of safety, EPKINLY carries warnings for serious CRS, immune effector cell-associated neurotoxicity syndrome (ICANS), infections, cytopenias, and embryo-fetal toxicity.
Genmab and AbbVie, co-developers of EPKINLY, continue to explore its potential in monotherapy and combination therapies across different types of lymphoma.
Source: businesswire.com
