Nuvation Bio Inc. has announced the publication of positive results from a Phase 2 study evaluating safusidenib, an oral inhibitor of mutant IDH1, in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant gliomas. The study, published in the journal Neuro-Oncology on November 8, assessed 27 patients and reported an objective response rate of 44.4%, with 87.9% of patients progression-free at 24 months. Median progression-free survival was not reached at a median follow-up of 28 months. The results support ongoing discussions with the FDA regarding the ongoing G203 study, which is being amended into a pivotal global Phase 3 trial in high-grade gliomas. A trial-in-progress poster on the G203 study was presented at the 30th Annual Meeting of the Society for Neuro-Oncology on November 21. A Good Clinical Practice noncompliance issue related to adverse event collection was identified and subsequently addressed through a re-investigation and re-collection of safety data.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nuvation Bio Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251203703470) on December 03, 2025, and is solely responsible for the information contained therein.
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