IDEAYA shares soar on positive late-stage melanoma trial data
April 13, 2026 10:03 AM
IH Market News
IDEAYA Biosciences (NASDAQ:IDYA) stock surged 27% on Monday after the company reported encouraging topline results from its Phase 2/3 registrational study evaluating darovasertib in combination with crizotinib for first-line treatment of metastatic uveal melanoma.
The OptimUM-02 study achieved its primary endpoint, demonstrating a statistically significant improvement in median progression-free survival (PFS). Patients receiving the combination therapy recorded a median PFS of 6.9 months, compared with 3.1 months for those given investigator-selected treatments, corresponding to a hazard ratio of 0.42 (95% CI: 0.30–0.59).
A total of 313 patients with HLA-A02:01-negative metastatic uveal melanoma were enrolled in the trial. Of these, 210 patients were treated with the darovasertib combination, while 103 were assigned to the control arm, where 76% received ipilimumab plus nivolumab and 24% were treated with pembrolizumab.
The secondary endpoint of overall response rate also favored the combination therapy, reaching 37.1% versus 5.8% for standard treatment options. The regimen reduced the risk of disease progression by 58%, based on blinded independent central review.
While overall survival data remains immature, the company noted an early signal of improvement in the combination arm. The therapy was generally well tolerated, with a manageable safety profile. The most frequently reported Grade 3 or higher adverse events included diarrhea, syncope and hypotension.
IDEAYA said it intends to file a New Drug Application with the U.S. Food and Drug Administration in the second half of 2026, seeking accelerated approval. Full results from the OptimUM-02 trial are expected to be presented at a major medical conference later in 2026.
The study was carried out in partnership with Servier, an international pharmaceutical group.
Original: IDEAYA shares soar on positive late-stage melanoma trial data
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