IDEAYA Biosciences, Inc, a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced further interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib combination in metastatic uveal melanoma (MUM) patients.
“The observed efficacy in first-line metastatic uveal melanoma patients – including confirmed ORR of 45% and median PFS of ~ 7 months – is clinically significant and represents a potential paradigm shift for treating MUM patients. The interim data for the darovasertib and crizotinib combination treatment in MUM suggests a compelling clinical efficacy and tolerability profile,” said Dr. Meredith McKean, M.D., MPH, Director, Melanoma and Skin Cancer Research at Sarah Cannon Research Institute.
“These clinical data, considered with the FDA’s guidance from our recent Type C meeting, provides IDEAYA with a registrational trial design in first-line HLA-A2 negative MUM patients which includes a path to potential accelerated approval based on median PFS as the primary endpoint,” said Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
There are currently no FDA approved therapies for MUM patients with HLA-A2*02:01 (HLA-A2) negative serotype. Current therapies for MUM have relatively low confirmed overall response rates and short median progression free survival (PFS), highlighting the high unmet medical need. The historical overall response rate (ORR) in MUM clinical trials has generally been reported with a confirmed ORR ranging from approximately 0% to 5%. The historical median PFS in MUM clinical trials has been reported ranging from approximately 2 to 3 months.
Darovasertib (IDE196) is a small molecule, potential first-in-class protein kinase C (PKC) inhibitor. IDEAYA is evaluating the synthetic lethal combination of darovasertib and crizotinib, a small molecule cMET inhibitor, in MUM pursuant to a clinical trial collaboration and drug supply agreement with Pfizer.
The company observed encouraging clinical activity in the Phase 2 clinical trial evaluating the darovasertib and crizotinib combination in first-line and any-line MUM patients. The reported Phase 2 clinical data are based on twenty (20) evaluable first-line and sixty-three (63) evaluable any-line patients enrolled in the darovasertib and crizotinib combination study at the expansion dose of 300 mg twice-a-day darovasertib and 200 mg twice-a-day crizotinib as of September 22, 2022.
SOURCE: PR Newswire