The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have authorised AB Science’s confirmatory Phase III Study AB22007 trial of masitinib in treating metastatic castrate-resistant prostate cancer (mCRPC), with a biomarker targeting those with less advanced metastatic disease.
The randomised, multicentre, prospective, double-blind, placebo-controlled trial was designed to confirm the safety and efficacy of docetaxel in combination with masitinib 6.0mg/kg/d, versus docetaxel + placebo in mCRPC.
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It will enrol 600 subjects with confirmed mCRPC eligible for docetaxel and with a biomarker indicative of less advanced metastatic disease.
The primary goal of the study is radiographic progression-free survival (rPFS), with overall survival (OS) as the first secondary goal.
According to the company, masitinib is positioned with docetaxel, administered following resistance or relapse after metastatic hormone-sensitive prostate cancer (mHSPC) treatments.
AB Science Scientific Committee president Olivier Hermine said: “The authorisation of our confirmatory Phase III study by both the FDA and EMA represents a critical milestone for masitinib in metastatic castrate-resistant prostate cancer.
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By GlobalData“With a validated biomarker guiding patient selection, this trial has the potential to establish the first targeted combination with docetaxel in nearly two decades for mCRPC.”
Findings from the previous study AB12003 showed that the biomarker alkaline phosphatase predicts the masitinib’s response in mCRPC.
Masitinib + docetaxel may offer a new first-line treatment alternative for mCRPC subjects having low metastatic involvement.
The primary analysis of AB12003, based on 450 subjects in the targeted subgroup with baseline alkaline phosphatase levels ≤250 IU/L, showed a significant PFS benefit for masitinib plus docetaxel, with a 21% decrease in risk of progression relative to control.
The efficacy of masitinib was correlated with the level of alkaline phosphatase levels, suggesting that early use in combination with docetaxel can slow down the progression of metastatic cancer resistant to hormone treatments.
Following the outcomes from AB12003, the company filed a patent application to treat mCRPC with masitinib.
The European Patent Office has granted this patent (EP4175639), protecting till 2042 for the therapy and related compounds for mCRPC treatment in patients with low metastatic involvement.
The company also filed for counterpart patent applications in the US and other international markets.
