FDA and EMA authorize phase 3 trial for masitinib in prostate cancer

AB Science has received FDA and EMA authorization for a confirmatory phase 3 trial of masitinib in metastatic castrate-resistant prostate cancer. The trial, targeting patients with less advanced metastatic disease, will enroll 600 patients and focus on radiographic progression free survival as the primary endpoint. Results from a previous study showed that the biomarker Alkaline Phosphatase predicts response to masitinib in mCRPC, offering a potential new treatment option for patients with low metastatic involvement. Prostate cancer is a common cause of cancer in men, with an estimated 75,000 eligible patients in the EU and 50,000 in the USA. A biomarker study revealed that masitinib treatment had a significant effect on patients with lower baseline ALP levels, reducing the risk of progression by 47%. The FDA and EMA have validated the use of ALP as a biomarker in phase 3 studies. Masitinib, in combination with docetaxel, showed promise in slowing the progression of metastatic cancer, even in patients resistant to hormone treatments. The safety profile of masitinib plus docetaxel was acceptable, with no new safety concerns reported. AB Science has filed a patent application to protect masitinib for treating mCRPC until 2042, based on positive study results.

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