Phase II Study of Safusidenib Erbumine in Patients with Chemotherapy- and Radiotherapy-Naïve Isocitrate Dehydrogenase 1-Mutated WHO Grade 2 Gliomas

    November 2025 in “ Neuro-Oncology ”
    Yoshiki Arakawa, Ryuta Saito, Yonehiro Kanemura, Kazuhiko Mishima, Shunichi Koriyama, Yoshitaka Narita, Toshihiro Kumabe, Kazuya Motomura, Kazuhiko Sugiyama, Fumiyuki Yamasaki, Akitake Mukasa, Masayuki Kanamori, Daisuke Kuga, Motoo Nagane, Yasuyuki Kakurai, Koji Isobe, Hideo Nakamura
    TLDR Safusidenib erbumine shows promise as a treatment for certain brain tumors, but mild side effects like hair loss need attention.
    This Phase II study evaluated safusidenib erbumine in 27 patients with chemotherapy- and radiotherapy-naïve IDH1-mutated WHO grade 2 gliomas, showing a confirmed objective response rate of 44.4% and an event-free probability of 87.9% at 24 months, indicating promising antitumor activity. The safety profile was manageable, with common mild to moderate adverse events such as alopecia (59.3%), arthralgia (55.6%), and skin hyperpigmentation (48.1%). The study suggests safusidenib erbumine as a potential treatment option, addressing a critical unmet need in managing WHO grade 2 gliomas, though safety concerns like alopecia need to be managed.
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