FDA grants second approval for EPKINLY in r/r follicular lymphoma

AbbVie (ABBV) “announced that the FDA has approved EPKINLY, or epcoritamab-bysp, as the first and only T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of prior therapy. This indication is approved under the FDA’s Accelerated Approval program based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Epcoritamab is being co-developed by AbbVie and Genmab (GMAB) as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. FDA approval is based on results from the Phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of EPKINLY in 127 adult patients with R/R FL who previously received a median of three lines of therapy and with 70% having double refractory disease. Results and safety findings include: The study results showed an overall response rate – the study’s primary endpoint – of 82%, a complete response rate of 60% and a partial response rate of 22%. At a median follow-up of 14.8 months among responders, more than half of patients who responded to treatment in the study remained responsive to treatment. The safety of EPKINLY at a target dose of 48 mg was evaluated in EPCORE NHL-1, a single-arm study of 127 patients who received a 2-step up dosage schedule. The most common (greater than or equal to20%) adverse reactions were injection site reactions, cytokine release syndrome, COVID-19, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, fever, cough, and headache. A separate dose optimization cohort evaluated 86 patients at the recommended 3-step dosage schedule for CRS mitigation. For the first full dose of this 3-step regimen, mandatory hospitalization was not required. There were no grade 3 CRS observed in patients with FL who received EPKINLY with the 3 step-up dosage schedule.”