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.

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