#United States #IDEAYA Biosciences #South San Francisco #uveal melanoma #darovasertib

IDEAYA Biosciences Reports Enrollment Completion for OptimUM-02 Trial

IDEAYA Biosciences, a prominent player in precision medicine oncology, has announced a significant achievement in its clinical development efforts. The company has completed the targeted enrollment of 435 patients for its pivotal Phase 2/3 trial, known as OptimUM-02. This trial evaluates the effectiveness of darovasertib, a novel oral protein kinase C (PKC) inhibitor, used in combination with crizotinib, an oral c-MET inhibitor developed by Pfizer, specifically for the treatment of *first-line HLAA2-negative metastatic uveal melanoma (mUM).

The completion of this enrollment marks a critical point in the study, setting a foundation for IDEAYA to file for potential full approval in the United States based on the outcomes observed in this clinical trial. With the anticipated release of median progression-free survival (PFS) data expected in the first quarter of 2026, the company is optimistic that these results will support a potential accelerated approval filing.

Context and Significance of the OptimUM-02 Trial

Uveal melanoma is a rare and aggressive form of eye cancer that unfortunately offers limited treatment options, leading to historically dismal survival rates. The urgent need for more effective therapies for this condition is highlighted by the trial’s design, which includes a comparison between the darovasertib and crizotinib combination and standard treatment options like pembrolizumab, a well-known immunotherapy, alongside ipilimumab + nivolumab and dacarbazine.

The primary endpoints of the trial are focused on median progression-free survival and median overall survival (mOS). The data collected will be crucial for assessing darovasertib's potential benefits compared to existing therapies and could ultimately lead to a substantial enhancement in treatment protocols for mUM.

In the recently concluded Phase 1/2 clinical trial (OptimUM-01), impressive results were reported, including a median overall survival of 21.1 months and median PFS of 7.0 months*. This data has raised hopes regarding the therapeutic potential of darovasertib, particularly in bridging treatment gaps for both HLAA2-negative and HLA*A2-positive patients.

IDEAYA's Future Aspirations

The President and CEO of IDEAYA Biosciences, Yujiro S. Hata, expressed enthusiasm over achieving the target enrollment, stating, “This milestone reflects both the clear unmet need in metastatic uveal melanoma and the strong clinical interest in our darovasertib program.” The company aims to make darovasertib combined with crizotinib available as a first-line treatment option, pending regulatory approval.

Additionally, darovasertib has gained recognition in the medical community, having received Breakthrough Therapy Designation from the FDA for its intended use in neoadjuvant settings and Fast Track designation for its combination with crizotinib in adults suffering from mUM. This progress underlines IDEAYA's commitment to addressing the challenges posed by this aggressive cancer effectively.

With ongoing efforts, IDEAYA is also engaging in enrolling participants for a pivotal Phase 3 trial focusing on darovasertib alone for primary uveal melanoma, indicating a robust pipeline of innovative solutions aimed at improving patient outcomes.

Closing Thoughts

As IDEAYA Biosciences continues on its path towards advancing therapies in the oncology field, the successful completion of the OptimUM-02 trial’s enrollment is a promising step forward in the battle against uveal melanoma. Stakeholders and patients alike will be eagerly awaiting the upcoming data, which could herald a new dawn for this challenging cancer landscape. IDEAYA's approach to precision oncology, emphasizing targeted therapies intertwined with genetic drivers of disease, may be key in changing the trajectory of treatment for patients battling uveal melanoma.