Epcoritamab-bysp receives accelerated U.S. FDA approval for the treatment of R/R FL

On June 26, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp, an off-the-shelf bispecific CD-20-directed CD3 T-cell engager, for the treatment of adults with relapsed and/or refractory (R/R) follicular lymphoma (FL), following ≥2 lines of systemic therapy. The approval was based on positive results from the EPCORE NHL-1 trial.^1,2

The EPCORE NHL-1 trial 

EPCORE NHL-1 trial is an open-label, multi-cohort, multicenter, phase I/II trial (NCT03625037), investigating the safety and preliminary efficacy of epcoritamab-bysp in adults with R/R FL after ≥2 lines of systemic therapy.^1,2

Among 127 patients receiving a 2-step-up dosing regimen:^1,2 

Efficacy was similar in the 86 patients receiving the recommended 3-step-up dosing regimen for mitigating cytokine release syndrome (CRS).¹

The most commonly reported adverse reactions in ≥20% of patients were injection site reactions, CRS, COVID-10 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache.^1,2 The prescribing information comes with a boxed warning for serious or fatal CRS and immune effector cell-associated neurotoxicity.^1,2

A phase III randomized trial (NCT05409066) is currently ongoing to investigate epcoritamab-bysp in combination with rituximab and lenalidomide in patients with R/R FL.^1,2