Nuvation Bio Launches Phase 3 SIGMA Trial of Safusidenib for IDH1-Mutant Glioma

Reuters02-09 21:00

<a href="https://laohu8.com/S/NUVB">Nuvation Bio</a> Launches Phase 3 SIGMA Trial of Safusidenib for IDH1-Mutant Glioma

Nuvation Bio Inc. has announced the expansion of its ongoing global SIGMA (G203; NCT05303519) study of safusidenib, a novel oral targeted inhibitor of mutant IDH1, to a pivotal Phase 3 trial. The SIGMA trial will evaluate the efficacy and safety of safusidenib compared to placebo as maintenance treatment for patients with high-risk or high-grade IDH1-mutant astrocytoma following standard-of-care therapies. The protocol amendment increases enrollment from 100 to 300 patients across the U.S., Australia, and China and broadens eligibility criteria to include grades 2 and 3 IDH1-mutant astrocytoma with high-risk features and grade 4 IDH1-mutant astrocytoma. The study will also include a non-pivotal single-arm cohort for chemotherapy- and radiotherapy-naïve patients with grade 3 IDH1-mutant oligodendroglioma. Initial data for the oligodendroglioma cohort are expected in 2027. Results from the current Phase 3 portion of the trial have not yet been presented.

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: 20260204350848) on February 09, 2026, and is solely responsible for the information contained therein.

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