A global oncology company, Nuvation Bio Inc., announced the enrollment of the first patient in part 2 of its global, randomized clinical trial, G203 (NCT05303519), which is evaluating safusidenib for the maintenance treatment of high-grade IDH1-mutant astrocytoma.

Safusidenib is a novel, oral, potent, and brain-penetrant targeted inhibitor of mutant IDH1. This trial focuses on patients with newly diagnosed Grade 3 (with high-risk features) or Grade 4 IDH1-mutant astrocytoma, a population with an aggressive form of brain cancer for which no targeted treatments are currently FDA approved to delay recurrence or progression.

Following standard initial treatments—resection, radiation or chemoradiation, and adjuvant chemotherapy—patients in the study will be randomized 1:1 to receive 250 mg of safusidenib or a placebo twice daily. Based on favorable discussions and alignment with the U.S. Food and Drug Administration (FDA), Nuvation Bio is currently processing a protocol amendment to finalize G203 as a global Phase 3 study, increasing the enrollment size to approximately 300 patients across sites in the U.S., Australia, and China, to support potential regulatory approval.

The primary endpoint agreed upon with the FDA is progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR), which the FDA agreed could support full approval in this maintenance setting. Secondary endpoints include overall survival and objective response rate. Dr. David Hung, CEO of Nuvation Bio, highlighted the urgency for effective options for these patients, who currently face a "watch and wait" period after initial treatment, and affirmed the company's commitment to bringing therapies with meaningful clinical benefits to those with severe unmet treatment needs. Nuvation Bio, which was founded in 2018, will provide further updates on the safusidenib program in an upcoming earnings call.