The advancement is based on previous observations of preliminary clinical efficacy. There are currently no FDA-approved therapies for this patient population.
It is estimated that 5% of patients with cutaneous melanoma have the GNAQ/11 mutation. This equates to an overall prevalence of approximately 70,000 patients in the US and 110,000 in the European Union.1
Reports estimate that 12% to 15% of patients with cutaneous melanoma go on to develop metastatic disease. GNAQ and GNA11 mutations have been identified in a large majority of patients who develop metastatic uveal melanoma (90%).1
The advancement is based on previous preliminary clinical efficacy observations.
"The clinical efficacy observed in a GNAQ melanoma patient that progressed on immune checkpoint inhibitor therapies and treated in our clinic has been durable and well tolerated. This is a very important finding in this biomarker defined population," said Marcus Butler, MD.1 Butler is a medical oncologist in the tumor immunotherapy program and the melanoma/skin oncology site lead at Princess Margaret Cancer Centre, as well as co-lead of the Ocular Melanoma Physician Task Force of Canada.
Currently, there are no FDA-approved therapies for patients of this genetically-defined population.
"As IDEAYA advances the registrational trial for darovasertib in first-line HLA-A2-negative metastatic uveal melanoma, it's a strategic priority to expand the program's clinical application in multiple solid tumor settings, including HLA-A2-positive metastatic uveal melanoma, neoadjuvant and adjuvant uveal melanoma, and GNAQ/11 cutaneous melanoma," said IDEAYA Chief Executive Officer Yujiro Hata.1
Reference
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