Nuvation Bio Announces Publication Of Results From Phase 2 Study Of Safusidenib In Patients With Chemotherapy- And Radiotherapy-Naïve Grade 2 IDH1-Mutant Gliomas

Safusidenib demonstrated durable responses, with an ORR of 44% and 88% of patients were progression-free at 24 months

Findings supported recent favorable interactions with FDA where alignment was reached on modifying the ongoing G203 into a pivotal trial in high-grade gliomas

Nuvation Bio Inc. (NYSE:NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced the publication of positive results from a Phase 2 study of safusidenib, a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1, in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant gliomas. The findings were first published online on November 8 in the journal of Neuro-Oncology.

As reported in the new publication, the open-label, multicenter, single-arm study evaluated 27 patients with IDH1-mutant grade 2 gliomas who had no prior anticancer therapy except for resection or biopsy. The study met its primary endpoint, demonstrating an objective response rate (ORR) of 44.4%; median duration of response could not be estimated because no progression events had occurred. As of the data cut-off (March 10, 2023), median progression-free survival (PFS) was not yet reached, with a median follow-up time of 28 months, demonstrating the long-term potential of safusidenib to delay disease progression. At 24 months, 87.9% of patients were progression free.

Adverse events were mostly mild to moderate and manageable. Grade 3 or greater treatment-related adverse events occurred in five (18.5%) patients. No grade 5 events were reported. Three (11.1%) patients had treatment-emergent adverse events that led to study treatment discontinuation, two of which were considered related to safusidenib by study investigators and were resolved with dose interruption and/or appropriate medical management.