This phase 1b/2 trial (EPCORE NHL-2, Arm 6) evaluated epcoritamab (subcutaneous CD3×CD20 bispecific antibody) combined with rituximab and lenalidomide as first-line chemotherapy-free treatment in 41 adults with grade 1–3A CD20+ follicular lymphoma, with a median follow-up of 35.9 months.
The investigator-assessed overall response rate was 95% (39/41 patients; 95% CI 84–99%) at ~3 years of follow-up. Grade 3–4 adverse events included neutropenia (49%), infections (29%), and COVID-19 (15%). Treatment-related deaths occurred in 3 patients (7%): septic shock, progressive multifocal leukoencephalopathy, and COVID-19.
Single-arm design with no comparator limits causal inference; small sample size (n=41) reduces precision of estimates; race data were missing in 29% of patients, limiting generalizability.
Epcoritamab plus rituximab-lenalidomide achieved a 95% response rate as first-line therapy for follicular lymphoma, but the 7% rate of treatment-related deaths—including PML—signals meaningful toxicity that warrants careful patient selection and monitoring before broader adoption.
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