This FDA approval marks the first subcutaneous bispecific antibody to be approved in patients with relapsed/refractory follicular lymphoma.
Lymphomas: © David A Litman - stock.adobe.com
The FDA has granted accerlated approval to epcoritamab for the treatment of relapsed/refractory follicular lymphoma after 2 or more lines of therapy. This is the first subcutaneously delivered bispecific antibody to be approved in this intent-to-treat population.1
In November 2023, the FDA granted epcoritamab breakthrough drug designation for follicular lymphoma.2 Epcoritamab is also approved to treat relapsed/refractory third-line DLBCL.
The approval is supported by data from the phase 1/2 EPCORE NHL-1 study which were presented at the 2023 American Society of Hematology Annual Meeting.3 Among 127 patients with follicular lymphoma that were enrolled to receive epcoritamab, the overall response rate (ORR) was 82% (95% CI, 74.1%-88.2%) with a complete response (CR) rate of 60%.1 The median progression-free survival (PFS) was 15.4 months and the median duration of response, duration of CR, and overall survival were not reached by the data cut-off. Further, minimal residual disease (MRD) negativity was associated with improved PFS.1,3
Regarding safety, the most common any-grade treatment-emergent adverse events (TEAEs) were cytokine release syndrome (CRS; 66%), injection site reaction (57%), COVID-19 (40%), fatigue (30%), neutropenia (28%), diarrhea (27%), and pyrexia (25%). The most common reason for treatment discontinuation was COVID-19, and TEAEs that led to discontinuation occurred in 19% of patients. No patients discontinued treatment due to CRS. TEAEs resulting in death occurred in 13 patients (10%).
The study’s primary end points were dose-limiting toxicities, incidence of adverse events, ORR, and incidence of CRS events.4 Secondary end points included number of patients with antilymphoma activity, DOR, changes in lymphoma symptoms, CR rate, duration of CR, PFS, time to CR, PFS, MRD negativity rate, OS, and pharmacokinetics.
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