AB Science today touted results from a study of masitinib in combination with docetaxel in treating prostate cancer.
Paris-based AB Science presented the data at the 2021 American Urological Association (AUA) annual meeting, according to a news release.
Masitinib in combination with docetaxel as a first-line treatment of metastatic castrate refractory prostate cancer (mCRPC) eligible to chemotherapy proved a potential first-line treatment option in the study, the company said.
The prospective, placebo-controlled, double-blind, randomized phase 3 trial evaluated the drug combination with a primary analysis performed on a pre-specified targeted subgroup, defined as patients with baseline alkaline phosphatase levels (ALP) ≤250 IU/ml, and on the overall population.
AB Science’s primary endpoint for the study was progression-free survival (PFS), with the study being determined successful if improvement in median PFS relative to control reached a 3.9% level of significance for the target subgroup. The primary analysis was based on 450 patients in the targeted subgroup from the total of 712 patients in the overall study cohort.
The findings included a significant PFS benefit from the treatment, corresponding to a 21% reduction in risk of progression relative to control. The safety profile for masitinib plus docetaxel was acceptable with respect to control and consistent with the known masitinib profile (neutropenia, anemia, diarrhea, and skin reactions) with no new safety signals observed.
“Results from study AB12003 indicate that the combination of masitinib plus docetaxel may provide a new first-line treatment option for mCRPC patients with low metastatic involvement. This is particularly striking because for years there have been many unsuccessful combination therapy trials with docetaxel in this indication,” study AB12003 senior investigator Michel Pavic said in the release. “Masitinib represents an innovative approach, being a small molecule drug that targets mast cell and macrophage activity. These are innate immune cells that are increasingly recognized as being critical components of the tumor microenvironment and associated with prostate cancer progression.”