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Darovasertib, Crizotinib Combination Advances Into Phase 2 Expansion for GNAQ/11 Metastatic Cutaneous Melanoma


The advancement is based on previous observations of preliminary clinical efficacy. There are currently no FDA-approved therapies for this patient population.

jaojormami/Adobe Stock
jaojormami/Adobe Stock

IDEAYA Biosciences has announced1 the phase 2 expansion of the combination darovasertib and crizotinib for the study of its efficacy in patients with GNAQ/11 metastatic cutaneous melanoma.

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

Key Takeaways

  • IDEAYA Biosciences expands phase 2 study for GNAQ/11 metastatic cutaneous melanoma.
  • Promising clinical efficacy observed in a GNAQ melanoma patient could benefit a genetically-defined population currently lacking FDA-approved therapies.

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


  1. IDEAYA Biosciences Inc. Ideaya Biosciences announces phase 2 expansion of Darovasertib and crizotinib combination in GNAQ/11 metastatic cutaneous melanoma. PR Newswire: press release distribution, targeting, monitoring and marketing. October 16, 2023. Accessed October 16, 2023. https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-phase-2-expansion-of-darovasertib-and-crizotinib-combination-in-gnaq11-metastatic-cutaneous-melanoma-301956860.html#:~:text=%22We%20are%20pleased%20to%20advance,M.D.%2C%20Ph.D.%2C

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