A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma

Summary

This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.

Timeline

Start

2020-07-08

Primary completion

2023-03-10

Completion

2026-08-31

Outcome

Met primary endpoint

release “The study met its primary endpoint, demonstrating an objective response rate (ORR) of 44.4%” nuvationbio.com ↗

Publications

• Arakawa Y, Saito R, Kanemura Y, Mishima K, Koriyama S, Narita Y, Kumabe T, Motomura K, Sugiyama K, Yamasaki F, Mukasa A, Kanamori M, Kuga D, Nagane M, Kakurai Y, Isobe K, Nakamura H. Phase II study of safusidenib erbumine in patients with chemotherapy- and radiotherapy-naive isocitrate dehydrogenase 1-mutated WHO grade 2 gliomas. Neuro Oncol. 2026 Mar 1;28(3):717-727. doi: 10.1093/neuonc/noaf258.
• Natsume A, Arakawa Y, Narita Y, Sugiyama K, Hata N, Muragaki Y, Shinojima N, Kumabe T, Saito R, Motomura K, Mineharu Y, Miyakita Y, Yamasaki F, Matsushita Y, Ichimura K, Ito K, Tachibana M, Kakurai Y, Okamoto N, Asahi T, Nishijima S, Yamaguchi T, Tsubouchi H, Nakamura H, Nishikawa R. The first-in-human phase I study of a brain-penetrant mutant IDH1 inhibitor DS-1001 in patients with recurrent or progressive IDH1-mutant gliomas. Neuro Oncol. 2023 Feb 14;25(2):326-336. doi: 10.1093/neuonc/noac155.

Drugs

Indications