IDEAYA Biosciences shares jumped after the company posted additional positive interim results from its Phase 2 clinical trial evaluating its darovasertib and crizotinib combination in metastatic uveal melanoma (MUM) patients.
As part of a clinical trial collaboration and drug supply agreement with Pfizer, IDEAYA is evaluating the combination of darovasertib, a potential first-in-class protein kinase C inhibitor, and crizotinib, a small molecule cMET inhibitor, in MUM.
IDEAYA said the interim results released on Monday confirmed the overall response rate of 45%, disease control rate of 90%, and median progression-free survival (PFS) of seven months in 20 First-Line MUM patients.
The results also confirmed an overall response rate of 30%, disease control rate of 87%, and median PFS of about seven months in 63 Any-Line MUM patients, and confirmed an overall response rate of 35%, disease control rate of 100%, and median PFS of about 11 months in 20 Hepatic-Only MUM patients.
IDEAYA noted that the historical percentage of overall response rate and median PFS for other MUM therapies have been low, ranging from 0% to 5% overall response rate and about two to three months median PFS.
“The interim data for the darovasertib and crizotinib combination treatment in MUM suggests a compelling clinical efficacy and tolerability profile," Dr Meredith McKean, director of Melanoma and Skin Cancer Research at Sarah Cannon Research Institute, said in a statement.
The company also announced that, following a recent Type C meeting with the US Food and Drug Administration (FDA), it is initiating a Phase 2/3 registrational trial in the second quarter of 2023 in First-Line HLA-A2 negative MUM, with median PFS as the primary endpoint for potential accelerated approval.
The company’s shares had added 25.9% at US$18.80 at noon on Monday.
Contact the author at emily.jarvie@proactiveinvestors.com
Follow her on Twitter @emilyjjarvie