IDEAYA Biosciences and Servier Provide Complete Data from Phase 2/3 Registrational OptimUM-02 Trial of the Darovasertib Combination in First Line HLA*A2:01 Negative Metastatic Uveal Melanoma in a Late-Breaking Oral Presentation at ASCO
IDEAYA Biosciences presented complete registrational data from the Phase 2/3 OptimUM-02 trial of darovasertib plus crizotinib in metastatic uveal melanoma at ASCO. The combination therapy met the primary endpoint, showing a statistically significant improvement in median progression-free survival of 6.9 months versus 3.1 months for investigator's choice of therapy (HR 0.42). The treatment also demonstrated a robust overall response rate of 37.1% compared to 5.8% in the control arm, with a manageable safety profile including a low 9.2% rate of treatment-related serious adverse events.
Key figures
- Drug Name
- darovasertib
- Phase Of Trial
- Phase 2/3
- Dcr ict pct
- 31.1
- Orr ict pct
- 5.8
- Total patients
- 313
- Tr sae rate pct
- 9.2
- Hazard ratio pfs
- 0.42
- Dcr darovasertib pct
- 73.3
- Orr darovasertib pct
- 37.1
- Median pfs ict months
- 3.1
- Pfs risk reduction pct
- 58
- Median pfs darovasertib months
- 6.9
- Discontinuation rate crizotinib pct
- 10
- Discontinuation rate darovasertib pct
- 2.5
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.