IDEAYA Biosciences Completes Enrollment in Pivotal Phase 2/3 Trial of Darovasertib and Crizotinib for Metastatic Uveal Melanoma

Reuters

2025/12/11

<a href="https://laohu8.com/S/IDYA">IDEAYA Biosciences</a> Completes Enrollment in Pivotal Phase 2/3 Trial of Darovasertib and Crizotinib for Metastatic Uveal Melanoma

IDEAYA Biosciences Inc. announced the completion of targeted full enrollment of 435 patients in its registration-enabling Phase 2/3 trial (OptimUM-02) evaluating darovasertib, an investigational oral protein kinase C inhibitor, in combination with Pfizer's crizotinib, an oral c-MET inhibitor, for first-line treatment of HLA*A2-negative metastatic uveal melanoma. The company expects to report median progression-free survival data from the trial in the first quarter of 2026 to support a potential accelerated approval filing in the United States. Median overall survival data will be used to support a potential full approval filing once available. Previous data from a single-arm Phase 2 trial (OptimUM-01) of the darovasertib and crizotinib combination, presented in October 2025, showed a median overall survival of 21.1 months and median progression-free survival of 7.0 months in first-line metastatic uveal melanoma.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. IDEAYA Biosciences Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: SF44398) on December 11, 2025, and is solely responsible for the information contained therein.

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The company expects to report median progression-free survival data from the trial in the first quarter of 2026 to support a potential accelerated approval filing in the United States. Median overall survival data will be used to support a potential full approval filing once available. Previous data from a single-arm Phase 2 trial (OptimUM-01) of the darovasertib and crizotinib combination, presented in October 2025, showed a median overall survival of 21.1 months and median progression-free survival of 7.0 months in first-line metastatic uveal melanoma.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. IDEAYA Biosciences Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: SF44398) on December 11, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4588","symbol_name":"碎股","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251211:nNDL9sPG9Y:1","article_id":"2590597931","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2590597931","pubTimestamp":1765450857,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"IDEAYA Biosciences Completes Enrollment in Pivotal Phase 2/3 Trial of Darovasertib and Crizotinib for Metastatic Uveal Melanoma. 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