FDA Adds Third-Line Follicular Lymphoma Indication to Epkinly Label

A year after receiving approval in the United States for treating diffuse large B-cell lymphoma (DLBCL), AbbVie and Genmab's bispecific T-cell engager, Epkinly (epcoritamab-bysp), has now received accelerated approval for patients with relapsed or refractory follicular lymphoma (FL) who have undergone at least two prior treatments. The U.S. Food and Drug Administration (FDA) granted this approval following a priority review, based on results from the Phase I/II EPCORE NHL-1 study involving 127 patients with relapsed or refractory FL.

Epkinly is a CD20xCD3 bispecific antibody that has shown promising results. The study revealed an overall response rate (ORR) of 82%, with 60% of patients achieving a complete response. Although the median duration of response (DOR) has not yet been reached after nearly 14 months, the 12-month Kaplan-Meier estimate for DOR stood at approximately 68%.

However, the treatment is not without risks. Epkinly comes with a boxed warning for Immune Effector Cell-Associated Neurotoxicity (ICANS), which occurred in about 6% of patients. Additionally, serious or fatal cytokine release syndrome (CRS) was also observed. In the EPCORE NHL-1 study, 66.4% of patients experienced CRS, with 1.6% of cases being Grade 3 or higher. Another dose optimization cohort involving 86 patients tested a three-step dosage regimen of Epkinly. In this group, 49% of patients experienced CRS, most of which were Grade 1. Analysts at BMO Capital Markets had previously highlighted the high incidence of CRS as a potential concern.

Epkinly was developed using Genmab's DuoBody technology and is administered subcutaneously. The development of this treatment is part of a collaboration between AbbVie and Genmab that began in 2020. The partners are also conducting a Phase III confirmatory study of Epkinly in combination with Rituxan (rituximab) and Revlimid (lenalidomide), compared with the administration of the two other treatments alone. This trial, which aims to further explore the efficacy and safety of Epkinly in relapsed or refractory FL patients, is currently 95% enrolled.