IDEAYA Biosciences, Inc. (IDYA), an oncology company, and Servier, an independent pharmaceutical group, announced positive topline results from the Phase 2/3 registrational trial named OptimUM-02, evaluating Darovasertib in combination with Crizotinib in patients with first-line HLA-A*A2:01-negative metastatic uveal melanoma (mUM).
The study met the primary goal of a statistically significant improvement in median progression-free survival or PFS relative to the investigator's choice of therapy or ICT arm as assessed by blinded independent central review or BICR.
Following the news, IDYA is trading 19.67% at $36.50 in the pre-market trading.
Darovasertib and OptimUM-02 Trial Findings
Darovasertib is an experimental cancer drug developed by IDEAYA Biosciences which has partnered with Servier for its development and commercialisation outside the United States.
OptimUM-02 is a global, randomised Phase 2/3 trial evaluating the Darovasertib and Crizotinib combination arm in 210 patients versus the ICT arm, consisting of 103 patients.
The ICT arm comprised 76% (n=78) patients on Ipilimumab plus Nivolumab (anti-CTLA-4/PD-1) and 24% (n=25) on pembrolizumab. The primary endpoint is median PFS as assessed by BICR, which will support an initial NDA submission in the United States.
Patients treated with the Darovasertib combination reduced their risk of disease progression as assessed by BICR by 58% and achieved a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm. The overall response rate (ORR) in the Darovasertib combination and ICT arm was 37.1% and 5.8%, respectively. The median duration of response (DOR) in the Darovasertib combination arm was 6.8 months.
The secondary endpoints in the study include overall response rate (ORR) and duration of response (DOR).
The Darovasertib combination was generally well-tolerated, with a manageable safety profile consistent with prior reported results and the known side effects of each drug, according to the firm.
Milestones Ahead
IDEAYA expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2026.
And IDEAYA plans to provide additional details from OptimUM-02 at a major medical conference in 2026.
Uveal melanoma (UM) is a rare, aggressive form of ocular cancer, and the firm estimates an annual incidence of primary UM of more than 10,000 patients globally, including North America, Europe and more than 3,000 patients in the United States, with approximately 50% of patients progressing to metastatic disease.
IDYA has traded between $15.84 and $39.28. The stock closed Friday's trade at $30.50, down 1.61%.
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