1. IDEAYA completed targeted enrollment of 435 patients in OptimUM-02 trial. 2. Median PFS data expected in Q1 2026 to support accelerated approval. 3. Darovasertib shows promise in treating HLA*A2-negative metastatic uveal melanoma. 4. FDA granted Breakthrough and Orphan Drug Designations for darovasertib. 5. OptimUM-02 aims for regulatory milestones and potential market entry soon.
FAQ
Why Bullish?
The completion of patient enrollment and positive trial data can lead to increased investor confidence and higher stock prices, similar to past instances where biotech firms experienced stock price surges after positive trial results or enrollment completions.
How important is it?
The article outlines significant milestones in IDEAYA's clinical trials, suggesting promising future earnings potential which can influence investor sentiment and stock price movement significantly.
Why Long Term?
With critical data expected in 2026, any positive results could drive sustained interest and investment in IDEAYA over the long term, potentially leading to increased revenue from product approval and sales.
IDAYA Achieves Full Enrollment in Pivotal Phase 2/3 Trial for Darovasertib
IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an innovative oncology company focused on precision medicine, has announced the completion of its targeted enrollment of 435 patients in the pivotal Phase 2/3 trial known as OptimUM-02. This trial assesses the efficacy of darovasertib, a novel oral protein kinase C (PKC) inhibitor, in combination with Pfizer's crizotinib, an oral c-MET inhibitor. The study focuses on first-line treatment for HLA*A2-negative metastatic uveal melanoma (mUM), a rare and aggressive cancer.
Timeline and Data Expectations
IDEAYA anticipates reporting median progression-free survival (PFS) data from the OptimUM-02 trial in the first quarter of 2026. This data will support a potential accelerated approval filing for darovasertib combined with crizotinib in the United States. Additionally, median overall survival (OS) data will be analyzed to assist in a potential full approval filing once available.
Clinical Significance of the Trial
Metastatic uveal melanoma is characterized by limited treatment options and historically low survival rates. Yujiro S. Hata, President and CEO of IDEAYA, expressed enthusiasm about achieving this milestone, emphasizing the unmet need within this patient population. “This milestone reflects both the clear unmet need in metastatic uveal melanoma, as well as the strong clinical interest in our darovasertib program," he stated. He reiterated the importance of the upcoming median PFS results to determine the drug's potential impact on patients.
Trial Design and Primary Endpoints
The OptimUM-02 trial is structured as a multi-arm, multi-stage, open-label study. Patients will be randomized to receive either the darovasertib and crizotinib combination or the investigator’s choice of existing therapies such as pembrolizumab or ipilimumab plus nivolumab. The primary endpoints of the study include:
- Median Progression-Free Survival (PFS)
- Median Overall Survival (OS)
These endpoints are crucial for supporting potential regulatory approvals for the innovative treatment.
Previous Clinical Findings
In October 2025, IDEAYA presented data from the Phase 1/2 trial (OptimUM-01) at the Society for Melanoma Research Congress. This data revealed a median OS of 21.1 months and median PFS of 7.0 months in first-line mUM patients, including both HLA*A2-negative and HLA*A2-positive groups.
Regulatory Designations for Darovasertib
Darovasertib has received several designations from the U.S. Food and Drug Administration (FDA), including Breakthrough Therapy Designation as neoadjuvant therapy for primary uveal melanoma and Fast Track designation in combination with crizotinib for adult patients with metastatic uveal melanoma. Furthermore, it has been classified as an Orphan Drug by the FDA.
IDEAYA is also progressing with the enrollment of patients in a pivotal Phase 3 trial, OptimUM-10, assessing single-agent darovasertib as neoadjuvant therapy for primary uveal melanoma.
About IDEAYA Biosciences
IDEAYA Biosciences is dedicated to the discovery and development of transformative cancer therapies. The company specializes in precision medicine that integrates small-molecule drug discovery with biomarker development, resulting in targeted therapies that align with the genetic drivers of various cancers.
Forward-Looking Statements
This announcement contains forward-looking statements regarding IDEAYA’s clinical programs and regulatory milestones. Achievements in enrollment, data readouts, and the path to approval are subject to substantial risks and uncertainties that may result in actual outcomes differing significantly from expectations.