IDEAYA to File Darovasertib NDA after 58% Progression Risk Reduction
IDEAYA's Phase 2/3 OptimUM-02 trial reduced disease progression risk by 58% and extended median PFS to 6.9 versus 3.1 months for darovasertib plus crizotinib. The FDA accepted its NDA for this combination under the RTOR program with pre-submission starting in May and full filing expected H2 2026.
1. Phase 2/3 OptimUM-02 Trial Results
In the OptimUM-02 registrational trial, darovasertib in combination with crizotinib met its primary endpoint by reducing the risk of disease progression by 58% (HR 0.42; 95% CI: 0.30–0.59; p<0.0001) and extending median PFS to 6.9 months versus 3.1 months in the comparator arm. Secondary analysis showed a 37.1% overall response rate with five complete responses and a median duration of response of 6.8 months, with tolerability consistent with prior data.
2. FDA Real-Time Oncology Review Submission
The FDA has agreed to review IDEAYA’s NDA for the darovasertib combination under the Oncology Center of Excellence Real-Time Oncology Review program, which allows rolling submission of clinical data. IDEAYA plans to submit the first pre-submission package in May and complete the full NDA filing in the second half of 2026.
3. Upcoming Milestones and Data Presentation
Full OptimUM-02 results will be disclosed in a late-breaking oral session at the 2026 ASCO annual meeting in Chicago. IDEAYA is also advancing darovasertib trials in HLA*A2-positive metastatic uveal melanoma and neoadjuvant/adjuvant settings for primary uveal melanoma.