Ideaya Biosciences Sees Positive Data From Darovasertib Trial

By Chris Wack

Ideaya Biosciences has reported positive interim Phase 2 clinical trial data for darovasertib in neoadjuvant uveal melanoma, or UM, as well as a successful Type C meeting with the Food and Drug Administration on registrational trial design for regulatory approval in neoadjuvant uveal melanoma.

The precision medicine oncology company said Monday that darovasertib demonstrated "compelling" preliminary clinical efficacy in the neoadjuvant UM setting, with 49% of patients demonstrating greater than 30% tumor shrinkage, and 61% eye preservation rate for enucleation patients. Enucleation refers to the clean removal of organs or tumors.

The primary clinical endpoints supported by discussions with the FDA of eye preservation and time to vision loss are clinically meaningful for neoadjuvant UM patients, and darovasertib "has the potential to provide a new standard of care in this setting," the company said.

Ideaya also said that the FDA Type C meeting--which relates to the development and review of a product--provided darovasertib a potential registrational path in neoadjuvant uveal melanoma, using primary clinical endpoints of eye preservation and time to vision loss.

Darovasertib is a potent and selective protein kinase C inhibitor being developed to broadly address primary and metastatic uveal melanoma. Darovasertib is currently being evaluated in four ongoing clinical trials, two of which are in collaboration with Pfizer.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

September 23, 2024 06:38 ET (10:38 GMT)

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