Darovasertib with crizotinib - (OptimUM-02)

Aug. 4, 2026: IDEAYA Biosciences (NASDAQ: IDYA) reported multiple oncology catalysts. Darovasertib + crizotinib in the registrational Phase 2/3 OptimUM-02 trial for first-line HLAA2:01-negative metastatic uveal melanoma met the primary endpoint: median PFS by BICR was 6.9 months vs 3.1 months for investigator’s choice (HR 0.42, 95% CI 0.30-0.59; p<0.0001); investigator-assessed PFS was 6.7 vs 2.7 months (HR 0.36; p<0.0001). OS was immature, with a pre-specified interim OS update expected in mid-2027. NDA filing is underway with FDA under RTOR, with completion expected in H2 2026. Updated OptimUM-01 data in HLAA2-positive mUM and OptimUM-09 neoadjuvant primary uveal melanoma data are planned for ESMO in October 2026. A global Phase 3 adjuvant trial, OptimUM-11, has started.

IDE849 (DLL3 TOP1 ADC): updated Hengrui Phase 1 data in SCLC/NEC, including ORR, PFS, safety and 12-month landmark OS in about 100 patients, will be presented at ESMO; first data from IDEAYA’s global Phase 1/2 trial are expected in H2 2026. IDEAYA is discussing a Phase 3 registrational design with FDA, targeting trial initiation by end-2026.

IDE892 (PRMT5): monotherapy expansion began in MTAP-deleted solid tumors; IDEAYA also announced a Roche collaboration to test IDE892 + RG6505 in MTAP-deleted, RAS-mutant pancreatic cancer, with Phase 1 start targeted for H2 2026. IDE034 initial Phase 1 data are expected by end-2026 or early 2027. IDEAYA plans an R&D Day in Q4 2026 focused on MTAP/CDKN2A, KRAS, and pancreatic cancer.