IDEAYA Biosciences announced that it has reached full enrollment of 435 patients in its Phase 2/3 OptimUM‑02 study, a registration‑enabling trial of the oral PKC inhibitor darovasertib combined with Pfizer’s crizotinib for first‑line HLA*A2‑negative metastatic uveal melanoma.
The OptimUM‑02 trial is designed to compare the darovasertib‑crizotinib combination against investigator’s choice of pembrolizumab, ipilimumab plus nivolumab, or dacarbazine. Enrollment of 435 patients places the study on track to deliver median progression‑free survival (mPFS) data in the first quarter of 2026, data the company intends to use to support a potential accelerated approval filing in the United States.
The completion of enrollment removes a key operational hurdle and brings the program closer to the regulatory submission window. For a rare and aggressive cancer with limited treatment options, the ability to generate robust efficacy data in a timely manner is a critical de‑risking step that could accelerate access to a first‑in‑class therapy.
IDEAYA’s broader pipeline includes other precision oncology candidates, such as IDE034 and IDE574, and the company has recently regained full control of the Werner Helicase (IDE275) and Pol Theta (IDE705) programs after ending a collaboration with GSK. The company’s cash runway extends into 2030, providing the financial flexibility to support continued clinical development and potential commercialization of darovasertib.
"This milestone reflects both the clear unmet need in metastatic uveal melanoma and the strong clinical interest in our darovasertib program," said Yujiro Hata, President and CEO of IDEAYA. Darrin Beaupre, MD, PhD, Chief Medical Officer, added, "The first reported overall survival data from OptimUM‑01 showed a median OS of 21.1 months, and the current enrollment positions us to confirm these encouraging signals in a larger, registration‑enabling study."
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