On May 23, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the publication of the abstract for an oral presentation of preliminary clinical results from its investigator-sponsored Phase 2 trial of darovasertib, a first-in-class oral, small molecular inhibitor of protein kinase C (PKC), as neoadjuvant/adjuvant treatment in uveal melanoma (UM) at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Ideaya Biosciences, MAY 23, 2024, View Source [SID1234643631]).
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Anthony Joshua, MBBS, PhD, FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent’s Hospital in Sydney, who is the leading principal investigator of the Phase 2 study, will present the clinical data from the Phase 2 Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma" (NADOM) study. Details of the presentation are as follows:
Session: Melanoma / Skin Cancers
Title: A Phase 2 Safety and Efficacy Study of Neoadjuvant/Adjuvant Darovasertib for Localized Ocular Melanoma
Date: Monday, June 3, 2024, at 9:51 AM CDT
In summary, 15 patients planned for enucleation with localized UM were treated with darovasertib 300mg twice daily. An initial safety cohort of 3 patients were treated for one month, and the remaining 12 patients were treated in an expansion cohort for up to six months as neoadjuvant treatment prior to their primary intervention (enucleation, plaque brachytherapy or external beam radiotherapy (EBRT)) across three Australian centers.
As of the database lock, 11 patients had completed primary treatment, four remained on neoadjuvant treatment, and six patients received adjuvant darovasertib after primary treatment of their UM with three patients completing the planned six months. At that time, approximately 67% (6 of 9 patients) had confirmed Eye Saved (i.e., converted to plaque brachytherapy or EBRT). Median tumor shrinkage (maximum volume change) was approximately 45% after six months.
The darovasertib monotherapy neoadjuvant treatment was generally well tolerated. Drug-related adverse events (AEs) were predominantly Grade 1 or Grade 2. Thirteen percent of patients reported at least one drug-related Grade 3 adverse event and no drug-related serious adverse events were observed.
Additional patients and further follow up from the abstract summary cut-off date will be presented on the June 3, 2024, ASCO (Free ASCO Whitepaper) oral presentation. A copy of the ASCO (Free ASCO Whitepaper) oral presentation will be available at approximately 10:00am CDT at its Investor Relations portal under "Events" (View Source) on the day of the presentation.