Precision medicine oncology company IDEAYA Biosciences Inc (Nasdaq: IDYA) on Monday announced the successful completion of a Type D meeting with the U.S. Food and Drug Administration regarding the design of its Phase 3 registrational trial for darovasertib as a neoadjuvant therapy in primary uveal melanoma (UM).

Targeting a launch in H1 2025, the trial will enrol approximately 520 patients across two cohorts: 120 enucleation-eligible patients and 400 plaque brachytherapy (PB)-eligible patients, randomised 2:1 to receive darovasertib or control. The study will assess darovasertib's ability to preserve vision and prevent eye removal prior to conventional treatment.

Eye preservation rate will serve as the primary endpoint for the enucleation cohort, while loss of visual acuity post-treatment will be the key measure for the PB cohort. A secondary endpoint of no detriment to event-free survival (EFS) is required for approval. IDEAYA may seek regulatory review for the enucleation data ahead of the PB cohort, pending EFS data maturity.

Darovasertib, a selective PKC inhibitor, holds FDA Breakthrough Therapy Designation in neoadjuvant primary UM and Fast Track designation in combination with crizotinib for metastatic UM. It is also designated as an Orphan Drug for UM.

IDEAYA's precision medicine approach integrates molecular diagnostics and biomarker-driven patient selection, with an emphasis on synthetic lethality targets.