This phase 1b/2 single-arm trial (EPCORE NHL-2, arm 3) evaluated epcoritamab (subcutaneous CD3×CD20 bispecific antibody) combined with bendamustine plus rituximab (BR) for 6 cycles, followed by epcoritamab monotherapy for up to 2 years, in 25 previously untreated follicular lymphoma (FL) patients; median follow-up was 41.3 months.
Best ORR and CR rate were both 96% (24/25 patients); median time to CR was 1.5 months. At 3 years, 87% of responders maintained CR, 3-year PFS was 83%, and 3-year OS was 96%. Only 3 patients (12%) had progression within 24 months (POD24). All CRS events were low grade (grade 1–2); no ICANS or clinical TLS occurred. Infections affected 92% of patients, with COVID-19 most common (84%); 1 fatal COVID-19 case and 1 biopsy-confirmed PML case were reported.
- Single-arm, non-randomized design with only 25 patients limits comparative conclusions and generalizability, especially for subgroup analyses. - High COVID-19 infection rate (84%) confounds the safety interpretation, as the trial ran during the pandemic. - Immunophenotyping data were not collected beyond cycle 7, limiting assessment of T-cell recovery during epcoritamab monotherapy.
In treatment-naïve FL patients with high disease burden, adding epcoritamab to BR yields deep, durable CRs sustained beyond 3 years, but the high infection burden—particularly COVID-19 and opportunistic infections—warrants careful patient selection and proactive infection prophylaxis. Confirmation in randomized trials is still needed before this replaces standard BR.
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