Business Wire·Dec 3, 2025, 8:00 AM ET

Nuvation Bio Announces Publication of Positive Phase 2 Study Results for Safusidenib for the Treatment of Grade 2 IDH1-Mutant Glioma in Neuro-Oncology

Nuvation Bio published positive Phase 2 results for safusidenib in chemotherapy- & radiotherapy-naïve grade 2 IDH1-mutant gliomas in Neuro-Oncology on November 8.
The study of 27 patients met its primary endpoint with an objective response rate (ORR) of 44.4% & a median progression-free survival not reached at 28 months of follow-up.
87.9% of patients remained progression-free at 24 months & 12 patients were still on treatment as of September 15, 2025.
Adverse events were mostly mild to moderate with 18.5% of patients experiencing Grade 3 or higher events & no Grade 5 events reported.
A Good Clinical Practice noncompliance issue regarding adverse event collection was identified & all safety data was re-investigated to ensure integrity.
The company reached FDA alignment on modifying the ongoing G203 study into a pivotal global Phase 3 trial for high-grade IDH1-mutant gliomas.
The G203 Phase 3 primary endpoint is progression-free survival assessed by Blinded Independent Central Review per Response Assessment in Neuro-Oncology 2.0.
Nuvation Bio is also evaluating enrollment of grade 2 patients with high-risk features in the G203 study.