{"url_path":"/sec/idya/8-k/2026-06-01/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-01","source_url":"https://www.sec.gov/Archives/edgar/data/1676725/0001193125-26-251399-index.html","accession_number":"0001193125-26-251399","cik":"0001676725","ticker":"IDYA","issuer_name":"IDEAYA Biosciences, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1676725/0001193125-26-251399-index.html","primary_entity_key":"0001676725","primary_entity_name":"IDEAYA Biosciences, Inc."},"word_count":851,"has_tables":true,"body_markdown":"Item 8.01\n\nOther Events.\n\nIDEAYA Biosciences and Servier Provide Complete Data from Phase 2/3 Registrational OptimUM-02 Trial of the Darovasertib Combination in First Line HLA*A2:01 Negative Metastatic Uveal Melanoma in a Late-Breaking Oral Presentation at ASCO\n\nOn June 1, 2026, the Company and Les Laboratoires Servier (“Servier”) presented complete data from the primary analysis of their registrational Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib (“darovasertib combination”) in first line (“1L”) HLA*A2:01 negative metastatic uveal melanoma (“mUM”) at ASCO. The data were provided in a late-breaking oral presentation by Dr. Marlana Orloff, M.D., Professor of Medical Oncology at Thomas Jefferson University Hospital and lead investigator on the trial.\n\nOptimUM-02 is a global, registrational Phase 2/3 trial evaluating a total of 313 patients with 1L HLA*A2:01 negative mUM, randomized 2:1 to the darovasertib combination or an investigator’s choice of therapy (“ICT”) arm reflective of real-world clinical practice that included ipilimumab plus nivolumab or pembrolizumab. The primary endpoint to support accelerated approval is median progression-free survival (“PFS”) as assessed by blinded independent central review (“BICR”). Secondary endpoints include safety and investigator assessed PFS, overall response rate (“ORR”), disease control rate (“DCR”) and duration of response. Data presented at ASCO were as of a cutoff date of January 23, 2026 and included additional detail on baseline characteristics as well as safety, secondary endpoints and median PFS across patient subgroups.\n\nKey Findings from OptimUM-02\n\n \n\n \n•\n \n\nPrimary endpoint (Phase 2 portion): progression free survival by BICR\n\n \n\n \n•\n \n\nThe trial met the primary endpoint, with patients treated with the darovasertib combination demonstrating a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm by BICR (HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001).\n\n \n\n \n•\n \n\nPatients treated with the darovasertib combination also had a statistically significant improvement in median PFS of 6.7 months versus 2.7 months for ICT by investigator assessment (HR: 0.36; 95% CI: 0.26, 0.50, p-value: <0.0001).\n\n \n\n \n•\n \n\nNotably, the darovasertib combination reduced the risk of disease progression by 58% and 64% as assessed by BICR and investigator assessment, respectively.\n\n \n\n \n•\n \n\nTreatment with the darovasertib combination demonstrated a consistent and meaningful improvement in median PFS relative to the ICT arm across a broad range of patient subgroups, including age and gender, type of immune therapy used in ICT, LDH stratification, ECOG status and site of metastasis.\n\n \n•\n \n\nSecondary endpoints: ORR, DCR, duration of response\n\n \n\n \n•\n \n\nPatients treated with the darovasertib combination had an ORR of 37.1% (78/210) and 39.5% (83/210) as assessed by BICR and investigator, respectively, compared to 5.8% (6/103) and 1.9% (2/103) in the ICT arm (p-value: <0.0001).\n\n \n\n \n•\n \n\nThe darovasertib combination led to a disease control rate of 73.3% (154/210) and 74.3% (156/210) by BICR and investigator assessment, respectively, compared to 31.1% (32/103) and 27.2% (28/103) in the ICT control arm.\n\n \n\n \n•\n \n\nThe median duration of response was 6.8 months (95% CI: 5.5, 11.3) by BICR and 6.8 months (95% CI: 4.8, 9.7) by investigator assessment based on a median follow-up time of 7.4 months as of the cutoff date.\n\n \n\n \n•\n \n\nOverall survival (Primary endpoint of the Phase 3 portion)\n\n \n\n \n•\n \n\nAs noted in the topline results, data on overall survival (“OS”) was still immature as of the cutoff date, however, there was an early trend in OS improvement in the darovasertib combination arm relative to the ICT arm.\n\n \n\n \n•\n \n\nThe Company will provide the next OS update as part of the pre-specified interim analysis. Overall survival data, when available, will be used to support a potential full approval in the United States and globally.\n\n \n\n \n•\n \n\nSafety\n\n \n\n \n•\n \n\nThe darovasertib combination was generally well-tolerated with a manageable safety profile consistent with previous results and known side-effects of each agent alone.\n\n \n\n \n•\n \n\nMedian relative dose intensities of darovasertib and crizotinib were 91.0% and 77.1%, respectively, compared to 100% for the ICT arm.\n\n \n\n \n•\n \n\nGrade 3/4 treatment-related adverse events (“TRAEs”) occurred in 40.6% (97/239) of patients in the darovasertib combination arm compared to 37.0% (37/100) of patients in the ICT control arm.\n\n \n\n \n•\n \n\nTreatment-related serious adverse events were 9.2% (22/239) and 25.0% (25/100) in the darovasertib combination and ICT arms, respectively.\n\n \n\n \n•\n \n\nLow discontinuation rate due to TRAEs for darovasertib (2.5%) and crizotinib (10.0%) relative to ICT (19.0%).\n\n \n\n \n•\n \n\nThe most common Grade 3/4 TRAEs included diarrhea (10.0%), syncope (7.1%) and hypotension (3.8%) in the darovasertib combination arm compared to elevated liver enzymes (ALT, 7.0% / AST, 7.0%), diarrhea (6.0%), hepatitis (5.0%) and colitis (4.0%) in the ICT control arm.\n\nIn April 2026, the Company announced the U.S. Food and Drug Administration (“FDA”) has agreed to review its new drug application (“NDA”) for darovasertib in combination with crizotinib under the Oncology Center of Excellence Real-Time Oncology Review program. This program allows applicants to pre-submit components of their NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The Company completed its first pre-submission in May and expects to complete the NDA filing in the second half of 2026."}