Leukemia & lymphoma · 2025
Subcutaneous epcoritamab monotherapy in Japanese patients with relapsed or refractory follicular lymphoma: primary results of the EPCORE NHL-3 trial.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеКлиническое исследование III фазыКлиническое исследование I 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, Conlon Rebekah, Takahashi Ami, D'Angelo Månsson Barbara, Favaro Elena, Fukuhara Noriko
Аннотация
An unmet need exists for patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose disease remains incurable. Epcoritamab, a subcutaneous CD3xCD20 bispecific antibody, is approved for R/R FL and different types of R/R large B-cell lymphoma after ≥2 prior lines of therapy (pLOT) in the US, Europe, and Japan. Regional data are critical to contextualize global trial data. In the Japan-specific EPCORE NHL-3 trial (phase 1/2), 21 adults with R/R FL and ≥2 pLOT received subcutaneous epcoritamab (two step-up doses, then 48-mg full doses) until progression. Median follow-up was 21.2 months. Responses were frequent and deep (overall response rate, 95.2%; complete response rate, 76.2%), including in high-risk subgroups, as well as durable. Safety was manageable; cytokine release syndrome events had predictable timing and were mostly low grade, and no fatal treatment-emergent adverse events occurred. These results support epcoritamab as a new treatment option for Japanese patients with R/R FL.Clinical trial registration numbers: NCT04542824; JapicCTI-205408; jRCT2080225312.