IDEAYA and Servier Present Darovasertib and Crizotinib Trial Data
IDEAYA Biosciences and Servier presented complete data from the primary analysis of their registrational Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib in first line HLA*A2:01 negative metastatic uveal melanoma at the 2026 American Society of Clinical Oncology Annual Meeting taking place in Chicago, Illinois. The data were provided in a late-breaking oral presentation by Dr. Marlana Orloff, M.D., Professor of Medical Oncology at Thomas Jefferson University Hospital and lead investigator on the trial. A copy of the presentation will be available on IDEAYA's corporate website. OptimUM-02 is a global, registrational Phase 2/3 trial evaluating a total of 313 patients with 1L HLA*A2:01 negative mUM, randomized 2:1 to the darovasertib combination or an investigator's choice of therapy arm reflective of real-world clinical practice that included ipilimumab plus nivolumab or pembrolizumab. The primary endpoint to support accelerated approval is median progression-free survival as assessed by blinded independent central review. Secondary endpoints include safety and investigator assessed PFS, overall response rate, disease control rate and duration of response. Data presented at ASCO were as of a cutoff date of January 23, 2026 and included additional detail on baseline characteristics as well as safety, secondary endpoints and median PFS across patient subgroups. Key Findings from OptimUM-02: Primary endpoint: progression free survival by BICR. The trial met the primary endpoint, with patients treated with the darovasertib combination demonstrating a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm by BICR. Patients treated with the darovasertib combination also had a statistically significant improvement in median PFS of 6.7 months versus 2.7 months for ICT by investigator assessment. Notably, the darovasertib combination reduced the risk of disease progression by 58% and 64% as assessed by BICR and investigator assessment, respectively. Treatment with the darovasertib combination demonstrated a consistent and meaningful improvement in median PFS relative to the ICT arm across a broad range of patient subgroups, including age and gender, type of immune therapy used in ICT, LDH stratification, ECOG status and site of metastasis. Secondary endpoints: ORR, DCR, duration of response: Patients treated with the darovasertib combination had an ORR of 37.1% and 39.5% as assessed by BICR and investigator, respectively, compared to 5.8% and 1.9% in the ICT arm. The darovasertib combination led to a disease control rate of 73.3% and 74.3% by BICR and investigator assessment, respectively, compared to 31.1% and 27.2% in the ICT control arm. The median duration of response was 6.8 months by BICR and 6.8 months by investigator assessment based on a median follow-up time of 7.4 months as of the cutoff date. Overall survival: As noted in the topline results, data on overall survival was still immature as of the cutoff date, however, there was an early trend in OS improvement in the darovasertib combination arm relative to the ICT arm. IDEAYA will provide the next OS update as part of the pre-specified interim analysis. Overall survival data, when available, will be used to support a potential full approval in the United States and globally. Safety: The darovasertib combination was generally well-tolerated with a manageable safety profile consistent with previous results and known side-effects of each agent alone. Median relative dose intensities of darovasertib and crizotinib were 91.0% and 77.1%, respectively, compared to 100% for the ICT arm. Grade 3/4 treatment-related adverse events occurred in 40.6% of patients in the darovasertib combination arm compared to 37.0% of patients in the ICT control arm. Treatment-related serious adverse events were 9.2% and 25.0% in the darovasertib combination and ICT arms, respectively. Low discontinuation rate due to TRAEs for darovasertib and crizotinib relative to ICT. The most common Grade 3/4 TRAEs included diarrhea, syncope and hypotension in the darovasertib combination arm compared to elevated liver enzymes, diarrhea, hepatitis and colitis in the ICT control arm.
