other material
confidence high
sentiment positive
materiality 0.85
IDEAYA reports positive Phase 2 darovasertib data in neoadjuvant uveal melanoma; FDA supports registrational Phase 3
IDEAYA Biosciences, Inc.
- 59% of 49 evaluable patients had >=20% ocular tumor shrinkage; 49% had >=30% shrinkage by product of diameters.
- Eye preservation rate of 61% in enucleation patients; 11% Grade 3+ AEs, 5% serious AEs, 3% discontinuation rate.
- FDA guidance: primary endpoint eye preservation for enucleation, time to vision loss for brachytherapy; ORR potential surrogate.
- Phase 3 planned with ~400 patients, two cohorts; 300mg BID dose; broad label possible for low/intermediate/high risk.
- Neoadjuvant UM annual incidence ~12,000 in NA/Europe/Australia; IDEAYA owns commercial rights (ex-Novartis license).