On October 23, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported enrollment of the first patient into part 2 of G203 (NCT05303519), a global, randomized study evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of patients with high-grade IDH1-mutant astrocytoma following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Safusidenib is a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1.

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"Following surgery and standard-of-care treatment, these patients and their healthcare providers are left to watch and wait for progression or recurrence," said Dr. Katherine Peters, professor of neurology and neurosurgery at the Preston Robert Tisch Brain Tumor Center at Duke Cancer Institute and a trial investigator. "Patients with this form of glioma need effective, well-tolerated options that can further delay this eventuality. Safusidenib has shown promising activity in a Phase 1 study of patients with recurrent or progressive high-grade IDH1-mutant gliomas, with higher response rates than other IDH inhibitors have demonstrated in this setting. We look forward to further studying its potential in this trial."

A protocol amendment is in progress to finalize G203 as a global Phase 3 study by increasing the study size to support potential regulatory approvals. Based on this amendment, which has been aligned on with the U.S. Food and Drug Administration (FDA), G203 part 2 is now enrolling approximately 300 patients with newly diagnosed IDH1-mutant astrocytoma—either grade 3 with high-risk features or grade 4—in the U.S., Australia, and China. Following resection, radiation or chemoradiation, and adjuvant chemotherapy, patients will be randomized 1:1 to receive 250 mg safusidenib or placebo twice daily. The primary endpoint is progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0; FDA agreed that the primary endpoint of PFS could support full approval in this setting. Secondary endpoints include overall survival, PFS as assessed by the investigator, objective response rate, and duration of response, among others.

"No targeted therapies have been approved to delay recurrence or progression in these patients, who are dealing with an aggressive disease that inevitably returns," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "With our first patient now enrolled in the U.S., we look forward to expanding the study into additional sites to support potential registration, as we continue our commitment to bringing therapies with meaningful clinical benefits to more patients with cancers that have severe unmet treatment needs."

Nuvation Bio will provide further updates on the progress of the safusidenib program in the upcoming earnings call on November 3, 2025.

About IDH1-Mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,400 people are diagnosed with IDH1-mutant gliomas each year. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, prognosis worsens for those with high grade tumors.

About Safusidenib
Safusidenib is a novel, oral, potent, brain-penetrant, targeted inhibitor of mutant IDH1. In a Phase 1 clinical study, safusidenib was well-tolerated and demonstrated anti-tumor activity and high blood-brain barrier penetration.

(Press release, Nuvation Bio, OCT 23, 2025, View Source [SID1234656968])