Nuvation Bio Enrolls First Patient in Global, Randomized Study of Safusidenib for Maintenance Treatment of High-Grade IDH1-Mutant Glioma
No targeted treatments are currently FDA approved for high-grade IDH1-mutant gliomas
After a favorable meeting with FDA, protocol amendment will make G203 a Phase 3 trial to support potential registration
Excerpt from the Press Release:
NEW YORK–(BUSINESS WIRE)– Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced 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.
“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.
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