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IDEAYA Announces Darovasertib Phase 2 Initiation in Neoadjuvant and Adjuvant Uveal Melanoma and Guidance for Clinical Data Update in Metastatic Uveal Melanoma
- Initiated Phase 2 clinical trial evaluating Darovasertib as neoadjuvant treatment of uveal melanoma prior to primary interventional treatment of enucleation
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"- Initiated Phase 2 clinical trial evaluating Darovasertib as neoadjuvant treatment of uveal melanoma prior to primary interventional treatment of enucleation or radiation therapy\n- Clinical protocol includes neoadjuvant treatment with Darovasertib to maximum benefit up to 6 months, primary treatment, then up to 6 months of follow-up adjuvant therapy\n- Neoadjuvant endpoints include eye preservation, reducing radiation and vision preservation; adjuvant endpoints include relapse free survival and useful vision\n- UM represents an unmet medical need and potential clinical expansion opportunity with annual incidence of approximately 8,700 patients in the US and EU\n- Targeting clinical data update for Darovasertib / Crizotinib Combination in MUM in 2023, including overall survival (OS) data\nSOUTH SAN FRANCISCO, Calif., Jan. 23, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced that it has initiated enrollment into a company-sponsored Phase 2 clinical trial to evaluate darovasertib as monotherapy in neo-adjuvant and adjuvant settings in primary, non-metastatic uveal melanoma (UM) patients. The company also provided guidance for an update on its Phase 2 clinical trial evaluating darovasertib in combination with crizotinib in metastatic uveal melanoma (MUM) patients in 2023. \n\"We are excited to clinically evaluate darovasertib as a neoadjuvant and an adjuvant treatment in uveal melanoma patients. This is a paradigm-shifting opportunity, as there are no approved systemic therapies in these settings. The preliminary clinical data shows clear evidence of anti-tumor activity and supports further clinical evaluation of darovasertib to determine its potential to either save the eye by avoiding enucleation, or to reduce the tumor thickness in the eye, enabling treatment with less radiation to preserve vision,\" said Dr. Carol Shields, M.D., Chief, Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University.\n\"The primary tumor shrinkage we are observing from just a single month of therapy in our investigator-sponsored NADOM study is very promising. We are looking forward to seeing even greater benefits in the IDEAYA-sponsored Phase 2 s...