Summary of IDEAYA Biosciences Update - February 23, 2026 Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Industry**: Precision medicine oncology - **Programs**: 9 clinical programs, with a focus on darovasertib in phase 3 studies for metastatic uveal melanoma [1][3] Key Points and Arguments Clinical Programs - **Darovasertib**: - Currently in two phase 3 randomized studies for first-line metastatic uveal melanoma and neoadjuvant indications [1] - Upcoming guidance on top-line results expected by the end of March 2026, focusing on median progression-free survival (PFS) as the primary endpoint [4][5] - Reported a solid 7-month PFS in previous presentations, with a follow-up of approximately 2 years [5][11] - **DLL3 Topo ADC (IDE-849)**: - Anticipated clinical data update by the end of 2026, with potential to be a best-in-class asset [2] - **MTAP Deletion Programs**: - Two clinical assets (PRMT5 and MAT2A) with opportunities for both monotherapy and combination therapy [2] - **KAT6/7 (IDE-574)**: - Entered phase 1, targeting a large patient population including breast and colorectal cancer [3] Trial Design and Expectations - **Trial Design**: - Simple randomized phase 3 comparison of darovasertib-crizotinib combination versus standard of care (checkpoint inhibitors) [15] - Control arm expected to show PFS of approximately 2-3 months based on meta-analyses [10][11] - **PFS and OS Analysis**: - The treatment arm is expected to outperform the control arm, with a significant buffer for achieving statistical significance [11][12] - Overall survival (OS) data shows a promising 21-month survival rate, with expectations for positive outcomes in the ongoing study [11][12][128] Patient Population and Disease Characteristics - **Uveal Melanoma**: - Majority of patients (over 90%) present with liver metastases, making liver-directed therapies critical [167][176] - Approximately one-third of patients have elevated LDH levels, indicating disease severity [180][181] Regulatory and Future Plans - **FDA Submission**: - Plans to file for approval based on PFS data, with OS data to be presented during the review process [136][186] - Anticipated timeline for filing and review is approximately 12 months, targeting first half of 2027 for potential approval [187] - **NCCN Guidelines**: - Plans to present data to the NCCN panel to support treatment inclusion for both HLA-A2 negative and positive patients [189] Neoadjuvant Study (OptimUM-09) - **OptimUM-09 Study**: - Focused on neoadjuvant treatment with promising results in tumor shrinkage and vision preservation [191] - Aims to change the treatment paradigm from surgical interventions to pharmacological management [195] Additional Important Information - **Safety Profile**: - Expected to be comparable to previous studies, with a focus on managing adverse events effectively [155] - Investigators are becoming more adept at handling treatment-related toxicities, which may lead to lower discontinuation rates [156] - **Data Review Process**: - The independent review of PFS is ongoing, with a target completion by the end of March 2026 [144] This summary encapsulates the key points from the IDEAYA Biosciences update, highlighting the company's focus on innovative oncology treatments, ongoing clinical trials, and strategic regulatory plans.