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Ideaya Biosciences Inc
IDEAYA Biosciences and Servier Announce Positive Topline Results from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA-A*02:01-Negative Metastatic Uveal Melanoma
Business
Apr 13 2026
4 min read

IDEAYA Biosciences and Servier Announce Positive Topline Results from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA-A*02:01-Negative Metastatic Uveal Melanoma

  • Trial met the primary endpoint showing statistically significant improvement in median PFS by BICR, with 6.9 months for the darovasertib combination versus 3.1 months for ICT (HR: 0.42; 95% CI: 0.30, 0.59; p-value: 10,000 patients globally (including North America, Europe and Australia) and >3,000 patients in the United States, with approximately 50% of patients progressing to metastatic disease (mUM). We estimate the majority (50-70%) of mUM patients are of the HLA-A*02:01-negative serotype. Currently, there are no FDA-approved systemic therapies for primary UM and no FDA-approved therapies for patients with HLA-A*02:01-negative mUM.

    About IDEAYA Biosciences

    IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. IDEAYA's corporate presentation is available on its website: https://ir.ideayabio.com/ 

    About Servier

    Servier is an independent international pharmaceutical group governed by a foundation. With its governance model, the Group is committed to therapeutic progress to serve patients and integrates the patient voice at every stage of the medicine life cycle. 

    As a leading global player in cardiology and venous diseases, Servier aims to become a leading innovator in oncology and neurology. The Group intends to deliver targeted therapeutic solutions, particularly in rare cancers and neurological diseases, and invests nearly 20% of its brand-name sales in R&D. 

    Headquartered in France, Servier relies on its more than 20,000 employees and a solid geographic presence with medicines distributed in more than 130 countries. In the 2024/25 financial year, the Group achieved revenues of €6.9 billion. 

    More information on the Group website: servier.com

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    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to the clinical significance and potential therapeutic benefit of darovasertib in combination with crizotinib; the interpretation of the topline results from the OptimUM-02 trial; the potential for the combination to become a new standard of care for first-line HLA-A*02:01-negative metastatic uveal melanoma; the sufficiency of the trial results to support regulatory submissions; the preliminary trends in overall survival data; the safety and tolerability profile of darovasertib combination; the timing and plans for submission of a New Drug Application (NDA) in the second half of 2026; the potential for accelerated approval in the United States; the timing and content of future data presentations; the development, regulatory and commercial plans for darovasertib; and the potential market opportunity for the combination therapy. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K for the year ended December 31, 2025 filed on February 17, 2026 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

    Investor and Media Contact

    IDEAYA BiosciencesJoshua Bleharski, Ph.D.Chief Financial Officerinvestor@ideayabio.com

    ServierService pressePresse@servier.com

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    SOURCE IDEAYA Biosciences, Inc.