Pharma Focus Asia

Ideaya Biosciences Announces Phase 2 Expansion for Darovasertib and Crizotinib Combination in GNAQ/11 Mutated Metastatic Cutaneous Melanoma

Tuesday, October 17, 2023

IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a company specializing in precision medicine for oncology, has announced the commencement of a Phase 2 expansion for the combination of darovasertib and crizotinib in the treatment of GNAQ/11 metastatic cutaneous melanoma.

IDEAYA Biosciences, expressed their satisfaction in moving forward with the darovasertib and crizotinib combination in Phase 2. He emphasized that this genetic-specific patient population lacks FDA-approved therapies, underscoring the significant medical need.

IDEAYA Biosciences, highlighted the strategic importance of expanding the clinical application of darovasertib in multiple solid tumor settings, which includes HLA-A2-positive metastatic uveal melanoma, neoadjuvant and adjuvant uveal melanoma, and GNAQ/11 cutaneous melanoma.

Dr. Marcus Butler, M.D., a Medical Oncologist at the Princess Margaret Cancer Centre in Toronto, Canada, noted the durable and well-tolerated clinical efficacy observed in a GNAQ melanoma patient who had previously progressed on immune checkpoint inhibitor therapies, highlighting the significance of this finding within this biomarker-defined population.

The decision to initiate the Phase 2 expansion of the darovasertib and crizotinib combination is based on promising clinical results observed in GNAQ/11 metastatic cutaneous melanoma cases. This form of melanoma is relatively rare, constituting around 5% of cases according to The Cancer Genome Atlas. In the US, it is estimated that approximately 5,000 patients are diagnosed annually, with around 8,000 patients in the EU28. The total estimated prevalence of GNAQ/11 cutaneous melanoma is around 70,000 patients in the US and 110,000 patients in the EU28.

Compared to cutaneous melanoma, uveal melanoma, which is predominantly associated with GNAQ/11 mutations, has a higher metastatic rate, estimated at around 50%. This expansion into GNAQ/11 cutaneous melanoma has the potential to double or more the annual addressable metastatic patient population when compared to metastatic uveal melanoma alone. Importantly, GNAQ/11 mutation patients typically exhibit low tumor mutational burden, making them less likely to benefit from immune checkpoint inhibitor therapies.

Darovasertib (IDE196) is a potent, selective small molecule inhibitor of protein kinase C (PKC). Approximately 90% of patients with metastatic uveal melanoma have been found to possess mutations in GNAQ or GNA11 (GNAQ/11). These mutations activate signaling pathways, including the oncogenic RAS/RAF/MEK/ERK pathway through PKC activation, which drives tumor progression.



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