IDEAYA在ESMO 2026前公布Darovasertib三项葡萄膜黑色素瘤试验更新数据，OptimUM-02中位PFS翻倍，维持2026年底NDA计划

IDEAYA Biosciences Inc. (IDYA), a precision medicine oncology company, on Monday released updated clinical data on three trials evaluating Darovasertib in treating metastatic and primary uveal melanoma (UM).
The data will also be presented at the 2026 Congress of the European Society of Medical Oncology (ESMO) later this month in Madrid, Spain.
Uveal melanoma (UM) is a rare, aggressive cancer arising from melanocytes in the eyes. While primary tumors can be treated by resection and chemotherapy, up to 30% of patients relapse into metastatic disease. It is estimated that 10,000-12,000 new cases are diagnosed globally every year, with 3,000 in the U.S. alone.
Darovasertib is an oral, small-molecule inhibitor of PKC proforms, which effect genes acting as oncogenic drivers of nearly all uveal melanoma cases. The drug is currently being assessed in trials in combination with the oral c-Met inhibitor crizotinib and as a single-agent neoadjuvant therapy. Darovasertib was previously granted a Fast Track, Orphan Drug, and Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
a) The Phase 1/2 OptimUM-01 trial is a single-arm, multi-center, open label dose escalation and expansion study that evaluated darovasertib in combination with crizotinib in UM patients with GNAQ/11 mutations. The study dosed 101 patients - 66% of which had received a previous line of treatment - with a median follow-up period of 10.4 months. The objective response rate (ORR) was reported as 22.1%. The disease control rate (DCR) reached 80.2%, while the median duration of response (DOR) was 7.4 months.Additionally, the study population demonstrated a median progression-free survival of 5.4 months, while overall survival (OS) came to 13.4 months.
b) The open-label Phase 2/3 OptimUM-02 trial evaluated the same darovasertib combination in patients with HLA-A*02:01-negative metastatic uveal melanoma (mUM). The company reported that the median PFS of patients treated with darvosertib more than doubled to 6.9 months, compared to 3.1 months in patients on the investigator's choice of therapy (ICT).
c) The Phase 2 OptimUM-09 trial evaluated single-agent darovasertib before local treatment in patients with primary uveal melanoma. The primary endpoint was set at preservation of the eye and reduction in the planned radiation dose. Tumor shrinkage exceeding 20% was observed in over 57.8% of dosed patients, while 86.3% were free from metastasis by 15 months after dosing.
The company plans to submit a new drug application (NDA) for Darovasertib under the oncology center of excellence (OCE) real-time oncology review (RTOR) program by the end of 2026.
IDYA closed Monday up 2.92% at $33.81.
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October 16, 2026 16:06 ET Monthly consumer price inflation data and retail sales figures were the main news from the U.S. economy this week. In Europe, monthly GDP figures from the U.K. gained attention. External trade data from China was in focus in Asia. Elsewhere, the International Monetary Fund released its latest projections for the global economy.