Nuvation Bio reports Phase 2 ORR 44.4% for safusidenib in IDH1-mutant gliomas

Nuvation Bio Inc.

Safusidenib met primary endpoint with 44.4% objective response rate in 27 Japanese patients with grade 2 IDH1-mutant gliomas.
Median PFS not reached at median 28 months follow-up; 87.9% progression-free at 24 months.
Grade 3+ treatment-related adverse events in 18.5% of patients; no grade 5 events; GCP noncompliance on safety reporting resolved via re-collection.
Company progressing G203 global Phase 3 study for high-risk IDH1-mutant glioma; FDA agreed PFS by BICR per RANO 2.0 could support full approval.

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