Ideaya Off Despite Positive Interim Phase 2 Data for Darovasertib, Successful FDA Type C Meeting

 

• Phase 2 company-sponsored and IST neoadjuvant uveal melanoma (UM) clinical data update in 49 evaluable patients, demonstrates ~49% of patients with >30% tumor shrinkage by product of diameters, and ~61% eye preservation rate for enucleation patients
• Targeting to initiate Phase 3 randomized registrational trial in neoadjuvant UM following finalization of the clinical protocol with FDA
• Clinical endpoints supportive of full approval based on FDA guidance: Eye preservation rate as the primary endpoint for enucleation patients. Time to vision loss as the primary endpoint for plaque brachytherapy patients. No detriment to Event-Free-Survival (EFS) in the treatment arms is a secondary endpoint
• Discussions ongoing with FDA to include ORR as a potential surrogate and composite endpoint to support earlier approval scenarios
• Based on FDA meeting, potential for consideration of broad indication label in neoadjuvant UM for subjects with low, intermediate, and high risk for metastatic disease
• Pending FDA discussions, we project registrational trial enrollment will be ~400 patients
• North America, Europe, and Australia annual incidence of primary UM is projected to be ~12k patients where there are currently no FDA-approved therapies
• Investor webcast with Company management and KOL scheduled for Mon Sept 23, at 8am ET

IDEAYA's darovasertib investor webcast presentation, as well as an updated corporate presentation, will be available on the company's website, at its Investor Relations portal (https://ir.ideayabio.com/) in advance of the investor webcast presentation today, Monday, September 23, 2024, at approximately 8:00 am ET.

https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-positive-interim-phase-2-data-for-darovasertib-and-successful-fda-type-c-meeting-on-registrational-trial-design-for-regulatory-approval-in-neoadjuvant-uveal-melanoma-302254630.html