Ideaya Biosciences (IDYA) announced interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib synthetic lethal combination in metastatic uveal melanoma patients. The historical overall response rate in MUM clinical trials has generally been reported with an ORR ranging from approximately 0 to 5%, including: pembrolizumab and tebentafusp; MEK inhibitor selumetinib in combination with dacarbazine; and cMET inhibitor cabozantinib monotherapy. In addition, the historical median PFS in MUM clinical trials has been reported ranging from approximately 2.0 to 2.8 months, including: tebentafusp; MEK inhibitor selumetinib in combination with dacarbazine; and cMET inhibitor cabozantinib monotherapy. Darovasertib is a small molecule, potential first-in-class protein kinase C inhibitor. IDEAYA is evaluating the synthetic lethal combination of darovasertib and crizotinib, a small molecule cMET inhibitor, in MUM and other GNAQ/11 tumors pursuant to a clinical trial collaboration and drug supply agreement with Pfizer (PFE). The interim Phase 2 clinical data update is based on an initial thirty-seven patients enrolled in the darovasertib and crizotinib combination study at the expansion dose of 300mg twice-a-day darovasertib and 200mg twice-a-day crizotinib, as of the data analysis cutoff date of June 26, 2022. Out of the thirty-seven patients enrolled, there were thirty-five evaluable patients and two non-evaluable patients. The two non-evaluable patients were both pretreated and withdrew from the trial prior to the first scan. Neither of the two non-evaluable patients progressed due to disease: one patient withdrew consent and one patient discontinued early due to fatigue. Reported data are preliminary and based on an unlocked database as of the data analyses cutoff date, except one confirmatory scan after the data cutoff date or as otherwise noted. Enrollment in the darovasertib and crizotinib combination expansion dose cohort of the clinical trial is ongoing. The company said it observed "encouraging" clinical activity in Phase 2 clinical trial evaluating darovasertib and crizotinib synthetic lethal combination in metastatic uveal melanoma patients in the expansion dose cohort. These data provide robust clinical proof-of-concept for the efficacy of the darovasertib and crizotinib synthetic lethal combination treatment, the company added. The darovasertib and crizotinib combination therapy has a manageable adverse event profile in MUM patients, with a low rate of drug-related serious adverse events. Patients reported predominantly Grade 1 or 2 drug-related adverse events. No patients observed Grade 4 or Grade 5 AE’s. One patient discontinued treatment due to a drug-related adverse event. IDEAYA is currently targeting to initiate a potential registration-enabling trial in Q1 2023. The company is evaluating first-line MUM as a potential registrational regulatory strategy. As of August 31, 2022, IDEAYA has enrolled 21 first-line MUM patients at the expansion dose of the darovasertib and crizotinib combination study.
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