Nuvation Bio reported positive long-term Phase 2 data for safusidenib in patients with IDH1-mutant glioma. The trial reached nearly 40 months of follow-up.
The study showed a confirmed objective response rate of 51.9%. The 36-month progression-free survival rate reached 79.1%.
Nuvation is expanding the clinical program to evaluate safusidenib across a broader spectrum of cases. The company will launch a pivotal Phase 3 trial for newly diagnosed patients outside the U.S.
A separate Phase 2 study will begin in the U.S. for patients whose disease progressed after treatment with vorasidenib.