other material
confidence high
sentiment positive
materiality 0.80
IDEAYA reports Phase 2 darovasertib data: median OS 21.1 mo in 1L mUM; 57% eye preservation
IDEAYA Biosciences, Inc.
- Darovasertib + crizotinib in 1L mUM: median OS 21.1 mo (historical ~12 mo), median PFS 7.0 mo, ORR 34%, DCR 90%.
- Neoadjuvant darovasertib in primary UM: 83% (78/94) of patients achieved tumor shrinkage; 54% >=20% shrinkage.
- Among patients recommended for enucleation, 57.1% (24/42) achieved eye preservation; in those with >=20% shrinkage, rate jumped to 95%.
- Predicted radiation reduction: 70% of Cohort 2 patients saw any reduction in predicted dose to critical eye structures; 64.9% had reduced 3-year vision loss risk.
- FDA Breakthrough Therapy Designation for neoadjuvant darovasertib; registration-enabling Phase 2/3 OptimUM-02 targeting median PFS data by year-end 2025 to Q1 2026.