FDA Approves Epcoritamab for Relapsed/Refractory Follicular Lymphoma

On June 26, 2024, the US Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab and AbbVie) for the treatment of adult patients with relapsed or refractory follicular lymphoma who received ≥2 prior lines of therapy.

Epcoritamab is a bispecific CD20-directed CD3 T-cell engager.

This approval was based on efficacy and safety of the drug demonstrated in the EPCORE NHL-1 study, an open-label, multicohort, multicenter, single-arm trial that included 127 patients. Primary efficacy and safety results were based on 127 patients who received epcoritamab administered in a 2 step-up dosing regimen. There was a second dose-optimization cohort that included 86 patients who received epcoritamab in a 3 step-up dosing schedule for cytokine release syndrome (CRS) mitigation.

The primary efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), as assessed by an Independent Review Committee using Lugano 2014 criteria.

Of the 127 patients included in the primary efficacy population, the ORR was 82% (95% confidence interval [CI], 13.7 to not reached [NR]) with 60% of patients achieving a complete response. Among responders, after an estimated median follow-up of 14.8 months, the estimated DOR was NR (95% CI, 13.7 to NR). The 12-month Kaplan-Meier estimate for DOR was 68.4% (95% CI, 57.6% to 77%).

Researchers noted that efficacy was similar in the dose-optimization cohort.

The most common adverse events (AEs) associated with epcoritamab (≥20%) were injection site reactions, CRS, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache. The most common grade 3 to 4 laboratory abnormalities (≥10%) were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and decreased hemoglobin.

A phase 3 randomized trial is underway to verify the clinical benefit of epcoritamab and is comparing rituximab and lenalidomide along or in combination with epcoritamab for patients with relapsed or refractory follicular lymphoma.

Source:

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma. Published online: June 26, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma