Nuvation Bio initiated a pivotal Phase 3 clinical trial for its targeted cancer therapy, safusidenib. The study focuses on patients with Grade 2 glioma featuring an IDH1 mutation.
This randomized, double-blind trial evaluates the efficacy and safety of the drug against a placebo in post-surgery patients. Safusidenib is an oral, brain-penetrant inhibitor of the mutant IDH1 enzyme.
The primary goal is to determine if the therapy can delay the need for subsequent chemotherapy or radiation. This initiation follows a February 2026 announcement expanding the overarching global SIGMA study.
The expansion converted the SIGMA study into a Phase 3 registrational trial. This specific arm targets patients with high-risk or high-grade astrocytomas.