International journal of hematology · 2026
Three-year follow-up of epcoritamab therapy in Japanese patients with relapsed/refractory follicular lymphoma in EPCORE NHL-3.
СтатьяКлиническое исследование I фазыКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Izutsu Koji, Akahane Daigo, Toubai Tomomi, Saito Toko, Mishima Yuko, Fujisaki Tomoaki, Nishikori Momoko, Kumode Takahiro, Suehiro Youko, Ishitsuka Kenji, Patah Poliana, Takahashi Ami, Månsson Barbara D'Angelo, Favaro Elena, Fukuhara Noriko
Аннотация
BACKGROUND: The CD3xCD20 bispecific antibody epcoritamab demonstrated deep, durable responses with manageable safety in relapsed/refractory (R/R) follicular lymphoma (FL) in EPCORE NHL-3 (phase 1/2; NCT04542824). This analysis evaluated 3-year follow-up outcomes in Japanese patients.
METHODS: Adults with CD20 + FL and ≥ 2 prior lines of therapy (LOTs) received subcutaneous epcoritamab (0.16/0.8-mg step-up doses; 48-mg full doses) until disease progression or death. The primary endpoint was overall response rate (ORR).
RESULTS: Twenty-one patients received epcoritamab (median age: 65 years; median prior LOTs: 4; 57.1% double refractory; 57.1% progressed within 24 months of any first-line treatment). At a median follow-up of 35 months, the ORR was 95.2% and the complete response (CR) rate was 76.2%. Median duration of response, duration of CR, progression-free survival, and overall survival were not reached. At 3 years, 66.7% and 93.3% of complete responders remained progression-free and alive, respectively. Minimal residual disease negativity was achieved in 88.9% (16/18) of evaluable patients. Common treatment-emergent adverse events included cytokine release syndrome (90.5%) and injection-site reaction (71.4%), all predominantly grade 1-2 and occurring in early treatment cycles, and none fatal.
CONCLUSIONS: Epcoritamab monotherapy provided durable long-term remission with favorable safety in Japanese patients with R/R FL over 3 years of follow-up.
METHODS: Adults with CD20 + FL and ≥ 2 prior lines of therapy (LOTs) received subcutaneous epcoritamab (0.16/0.8-mg step-up doses; 48-mg full doses) until disease progression or death. The primary endpoint was overall response rate (ORR).
RESULTS: Twenty-one patients received epcoritamab (median age: 65 years; median prior LOTs: 4; 57.1% double refractory; 57.1% progressed within 24 months of any first-line treatment). At a median follow-up of 35 months, the ORR was 95.2% and the complete response (CR) rate was 76.2%. Median duration of response, duration of CR, progression-free survival, and overall survival were not reached. At 3 years, 66.7% and 93.3% of complete responders remained progression-free and alive, respectively. Minimal residual disease negativity was achieved in 88.9% (16/18) of evaluable patients. Common treatment-emergent adverse events included cytokine release syndrome (90.5%) and injection-site reaction (71.4%), all predominantly grade 1-2 and occurring in early treatment cycles, and none fatal.
CONCLUSIONS: Epcoritamab monotherapy provided durable long-term remission with favorable safety in Japanese patients with R/R FL over 3 years of follow-up.