Nuvation Bio Amends Safusidenib Trial Protocol in Recurrent Astrocytoma, Adjusts Dosing and Monitoring

Nuvation Bio Inc. (NUVB) announced a protocol amendment to its ongoing Phase 2 clinical trial evaluating safusidenib in patients with recurrent grade 3 and 4 astrocytoma, a rare and aggressive form of glioma. The change, implemented following interim safety data and clinical observations, modifies the dosing schedule from once-daily administration to a split-dose regimen administered twice daily. This adjustment aims to improve tolerability while maintaining therapeutic exposure levels. Additionally, the protocol now includes more frequent neurocognitive assessments and expanded laboratory monitoring for hepatic and hematologic parameters. The trial, which currently enrolls 86 patients across multiple U.S. centers, is designed to evaluate progression-free survival at 6 months and overall response rates. The updated protocol reflects a proactive adjustment to optimize patient safety and data quality. Nuvation reports that 22 patients had previously experienced dose-limiting toxicities under the original dosing, prompting the revision. The company anticipates that the amendment will not delay the trial’s primary endpoint readout, expected in late 2026. The modification is being monitored closely by investors due to the high-risk, high-reward nature of NUVB’s pipeline. Safusidenib, a selective inhibitor of mutant isocitrate dehydrogenase 1 (IDH1), is being developed for IDH1-mutant gliomas, a subset of brain tumors with limited treatment options. The stock experienced a 7.3% intraday fluctuation on the news, with heightened trading volume observed in the morning session. The amendment underscores Nuvation’s commitment to rigorous clinical development in a niche but underserved oncology segment.