07:35 AM EDT, 09/23/2024 (MT Newswires) -- Ideaya Biosciences ( IDYA ) said Monday that a phase 2 trial evaluating investigational drug darovasertib for treating neoadjuvant uveal melanoma showed interim results that were "clinically meaningful."
About 49% of the study's patients exhibited more than 30% tumor shrinkage in diameters and showed around 61% eye preservation rate.
Ideaya said it completed a Type C meeting with the US Food and Drug Administration, allowing the company to push through with a phase 3 trial for darovasertib in neoadjuvant uveal melanoma.
The company is targeting a phase 3 trial enrolling 400 patients, with eye preservation rate as the primary endpoint and no dangers to event-free survival as a secondary endpoint.
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