IDEAYA Biosciences doses first Phase 3 trial patient
- IDEAYA Biosciences (NASDAQ:IDYA) announced the dosing of the first patient in its global Phase 3 OptimUM-11 clinical trial evaluating darovasertib for primary uveal melanoma.
- The company and its international pharmaceutical partner Servier will share the associated global development costs for the Phase 3 registrational trial.
- Management stated that the combination therapy could establish a new adjuvant treatment option to delay or prevent metastatic recurrence in high-risk patients.
IDEAYA Biosciences (NASDAQ:IDYA) dosed the first patient in its Phase 3 OptimUM-11 trial to evaluate darovasertib as a first-in-class adjuvant therapy for primary uveal melanoma.
The global registrational study aims to address a critical unmet need for patients who currently have no approved systemic adjuvant treatment options following primary local therapy.
"Dosing the first patient in OptimUM-11 represents an important milestone in our strategy to advance darovasertib across the uveal melanoma patient journey," said IDEAYA Biosciences Chief Medical Officer Darrin M. Beaupre.
The clinical trial expects to enroll approximately 450 high-risk patients who will be evenly randomized to receive the darovasertib and crizotinib combination therapy for 12 months or standard observation.
The company retains all regulatory and commercial rights to the investigational protein kinase C inhibitor in the United States while Servier holds exclusive rights in all other international markets.
The drug developer has also initiated a rolling new drug application for darovasertib in first-line metastatic uveal melanoma, with regulatory submission completion expected in the second half of 2026.
