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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
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Overall response rate was 82% (95% confidence interval [CI], 74.1%−88.2%), and complete response rate was 60%.
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12-month Kaplan-Meier estimate for duration of response was 68.4% (95% CI, 57.6%−77.0%).
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
References
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