IDEAYA Biosciences and Servier have reported positive top line results from the Phase II/III registration trial, OptimUM-02, assessing darovasertib in combination with crizotinib for first-line HLA-A*02:01-negative metastatic uveal melanoma.
The randomised, global trial identified a statistically significant improvement in median progression-free survival (PFS) for patients receiving the combination relative to the investigator choice of therapy (ICT) arm, assessed by blinded independent central review.
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It enrolled 313 patients, including 210 in the darovasertib combination arm and 103 in the ICT arm.
The ICT group received ipilimumab plus nivolumab in 76% of cases, totalling 78 patients, while 24%, or 25 patients, received pembrolizumab, reflecting real-world clinical practice.
The median PFS, the study’s primary endpoint, will support an initial new drug application submission in the US. PFS analysis was based on 159 events.
Patients in the darovasertib arm reduced their risk of disease progression by 58% and achieved a median PFS of 6.9 months compared to 3.1 months for the ICT arm.
The overall response rate (ORR) was 37.1% for the darovasertib combination, with five complete responses, compared to 5.8% for ICT with no complete responses. Median duration of response in the darovasertib arm was 6.8 months.
Overall survival data are not mature; however, there is an early trend of improvement with the darovasertib combination.
The safety profile was consistent with previous reports, with Grade 3+ adverse events including diarrhoea, syncope, and hypotension. Serious adverse events were reported at a single-digit per cent rate.
Ideaya expects to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) in the second half of 2026 and will release further OptimUM-02 data at a key medical conference.
Ideaya Biosciences president and CEO Yujiro Hata said: “OptimUM-02 is the first randomised study to demonstrate a statistically significant and clinically meaningful benefit in PFS in the clinical setting of first-line HLA-A*02:01-negative metastatic uveal melanoma.
“For patients with uveal melanoma, these results potentially offer a new treatment option that delivers a significant clinical advancement in both PFS and ORR versus currently available therapies.”
In December 2025, Ideaya received FDA clearance of an investigational new drug application to begin a Phase I clinical trial of IDE034 for multiple solid tumour types.
