IDEAYA’s Darovasertib Combo Cuts Progression Risk 58%, Targets NDA in H2 2026
IDEAYA reported that its Phase 2/3 OptimUM-02 trial in first-line HLA*A2-negative metastatic uveal melanoma met its primary endpoint, showing a 58% progression risk reduction (HR 0.42; p<0.0001) and extending median PFS to 6.9 versus 3.1 months. The company holds $973 million with runway into 2030 and plans RTOR NDA submission in H2 2026.
1. OptimUM-02 Trial Results
IDEAYA’s Phase 2/3 OptimUM-02 trial in first-line HLA*A2-negative metastatic uveal melanoma met its primary endpoint, demonstrating a 58% reduction in disease progression risk (HR 0.42; p<0.0001) and extending median PFS to 6.9 versus 3.1 months. The darovasertib plus crizotinib combination achieved a 37.1% overall response rate, including five complete responses, versus 5.8% in the investigator-choice arm, with a manageable safety profile.
2. NDA Plans and RTOR Submission
IDEAYA will present complete OptimUM-02 data at ASCO 2026 and initiate the RTOR submission process with a pre-submission in May, targeting full NDA filing in the second half of 2026 to support potential accelerated approval.
3. Financial Position and Cash Runway
As of March 31, 2026, IDEAYA held approximately $973 million in cash, cash equivalents and marketable securities, providing a cash runway into 2030 under current guidance.
4. Pipeline and Upcoming Trials
The company plans second-half 2026 data updates from Phase 2 OptimUM-01 in HLA*A2-positive metastatic uveal melanoma, Phase 2 OptimUM-09 in neoadjuvant primary uveal melanoma, and Phase 1/2 trials of IDE849 and IDE034 ADCs. Registrational IDE849 monotherapy and IDE892/IDE397 combination studies are slated for initiation by year-end 2026 and mid-2026, respectively.