Trial Profile

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

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 24 Jul 2026

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At a glance

20 Jul 2026 Results presented in a Nuvation Bio media release
20 Jul 2026 According to a Nuvation Bio media release, updated positive long-term follow-up data from phase 2 (J201) study of safusidenib in patients with chemotherapy- and radiotherapy-naive grade 2 IDH1-mutant glioma. With an additional year of follow-up, responses to safusidenib increased and further deepened, and its safety profile remained consistent and manageable.
03 Dec 2025 According to a Nuvation Bio media release, Primary endpoint has been met. (Overall response rate (ORR) assessed by Independent Efficacy Review Committee)

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