other material
confidence high
sentiment positive
materiality 0.80
IDEAYA announces Phase 2/3 trial met primary endpoint; darovasertib combo reduces progression risk by 58%
IDEAYA Biosciences, Inc.
- Darovasertib + crizotinib reduced risk of disease progression by 58% (HR 0.42, p<0.0001) in 1L HLA-A*02:01-negative mUM.
- Median PFS 6.9 months vs 3.1 months for investigator choice therapy (ICT) arm.
- ORR 37.1% vs 5.8% for ICT; 5 complete responses in combo arm, none in ICT.
- NDA submission to FDA targeted for second half of 2026.
- Safety profile manageable; Grade 3+ events included diarrhea, syncope, hypotension.