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For the trial, a biomarker will be utilized to aid in patient selection for the treatment.
The FDA and European Medicines Agency (EMA) have granted authorization for a confirmatory phase 3 trial that will evaluate masitinib in metastatic castrate-resistant prostate cancer (mCRPC), AB Science SA reported in a news release.1
For the trial, study AB22007, a biomarker will be utilized to aid in patient selection for the treatment.
The primary end point is radiographic progression-free survival, and the first secondary end point is overall survival.
“The authorization of our confirmatory phase 3 study by both the FDA and EMA represents a critical milestone for masitinib in metastatic castrate-resistant prostate cancer. With a validated biomarker guiding patient selection, this trial has the potential to establish the first targeted combination with docetaxel in nearly 2 decades for mCRPC,” said Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France, in the release.1
According to AB Science, “Study AB22007 is a prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study” that is meant to evaluate the efficacy and safety of docetaxel (75 mg/m2 intravenously plus prednisone for up to 10 cycles) plus masitinib 6.0 mg/kg/d vs docetaxel plus placebo in patients with mCRPC.1
The company plans to enroll 600 patients with confirmed mCRPC who are eligible for docetaxel treatment and whose baseline alkaline phosphatase (ALP) level points to less advanced metastatic disease. The primary end point is radiographic progression-free survival (rPFS), and the first secondary end point is overall survival.
Previous Results from AB12003
In the news release from AB Science, the company explained that results from study AB12003 indicated that lower baseline levels of ALP were predictive of a better treatment effect of masitinib. Specifically, “Masitinib (6.0 mg/kg/day) plus docetaxel confers a significant PFS benefit in mCRPC patients with ALP ≤ 250 IU/L,” AB Science wrote in the release.1
The prospective, placebo-controlled, double-blind, randomized phase 3 AB12003 study evaluated masitinib (6.0 mg/kg/d) in combination with docetaxel (75 mg/m2 intravenously plus prednisone for up to 10 cycles) for first-line treatment of mCRPC. Patients were eligible for the trial if they were chemotherapy naïve and had confirmed mCRPC that progressed on previous treatment with abiraterone acetate (Zytiga) or who were indicated for treatment docetaxel, and had an ECOG Performance Status of 0 or 1. The investigators performed a primary analysis on a pre-specified targeted subgroup of patients with baseline ALP levels of 250 IU/L or lower, as well as the overall population. The study’s primary end point was PFS. The primary analysis was based on 450 patients in the subgroup who had baseline ALP of 250 IU/L or lower; 712 patients comprised the entire cohort.
AB Science reported a significant PFS benefit with masitinib plus docetaxel in patients with mCRPC with ALP levels of 250 IU/L or lower, with an HR of 0.79 corresponding to a 21% reduction in risk of progression vs control. In addition, a 47% reduced risk of progression was observed in patients with ALP levels of 100 IU/L or lower (HR=0.53, P = .002).
REFERENCE
1. AB Science: Masitinib receives FDA and EMA authorization for confirmatory phase 3 trial in metastatic castrate-resistant prostate cancer. News release. AB Science. July 4, 2025. Accessed July 7, 2025. https://www.globenewswire.com/news-release/2025/07/04/3110206/0/en/AB-Science-Masitinib-receives-FDA-and-EMA-authorization-for-confirmatory-phase-3-trial-in-metastatic-castrate-resistant-prostate-cancer.html
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