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Adding epcoritamab to the standard R2 regimen dramatically improves outcomes in relapsed or refractory follicular lymphoma. Phase 3 data from the EPCORE FL-1 trial showed a 79% reduction in the risk of disease progression or death, with response rates nearly doubling. The FDA already approved this chemo-free combo in November 2025.
The phase 3 EPCORE FL-1 trial has delivered striking results: adding epcoritamab — a CD3 × CD20 bispecific antibody — to the established lenalidomide and rituximab (R2) regimen slashes the risk of disease progression or death by 79% in patients with relapsed or refractory follicular lymphoma (R/R FL). Presented at the Society of Hematology Oncology 2026 Annual Meeting, these findings cement epcoritamab plus R2 as a new benchmark in second-line-plus treatment.
The trial enrolled 488 patients across 189 centers in 30 countries, with a meaningful proportion carrying higher-risk disease features. The regimen is fully chemotherapy-free, fixed-duration, and suitable for outpatient administration — a significant practical advantage for patients and clinicians alike.
By the Numbers
Why it matters: These results supported the FDA's November 2025 approval of epcoritamab plus R2 — the first bispecific-based regimen approved in the second-line-or-later setting for R/R FL. For the many patients who relapse or don't respond durably to R2 alone, this chemo-free combination offers a substantially better shot at deep, lasting remission.