NEW YORK — Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on addressing some of the most difficult challenges in cancer treatment, has enrolled the first patient in part 2 of its G203 (NCT05303519) global, randomized study evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of patients with high-grade IDH1-mutant astrocytoma. The treatment follows standard-of-care radiation or chemoradiation and adjuvant temozolomide. Safusidenib is a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1.
“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 underway to transition G203 into a global Phase 3 trial by increasing the study size to support potential regulatory approvals. Following alignment with the U.S. Food and Drug Administration (FDA), the expanded trial will enroll approximately 300 patients with newly diagnosed IDH1-mutant astrocytoma—either grade 3 with high-risk features or grade 4—across sites in the United States, Australia, and China.
After surgery, radiation or chemoradiation, and adjuvant chemotherapy, patients will be randomized 1:1 to receive 250 mg of 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. The FDA has agreed that PFS may serve as the primary endpoint to support full approval in this setting. Secondary endpoints include overall survival, investigator-assessed PFS, objective response rate, and duration of response.
“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.”
