Prostate cancer is one of the most common types of cancer in men. There is still a need for more effective first-line treatment of metastatic castrate-resistant prostate cancer (mCRPC) since recent therapies approved for CRPC are drugs used either prior to chemotherapy or used for non-metastatic castrate-resistant prostate cancer. The only approved drug in metastatic castration resistant prostate cancer eligible to chemotherapy is docetaxel.
Masitinib is currently developed in first-line CRPC. This patient population consists of patients who have disease progression despite androgen depletion therapy (medical castration).
The number of patients targeted by masitinib amounts to 125,000 in Europe and in the US.
This phase 1/2 study which included patients with Hormone Refractory Prostate Cancer (HRPC) in progression after first line of treatment, tested the combination of masitinib with docetaxel. The median overall survival reached 18.4 months in the masitinib plus docetaxel arm with a lower bound of the corresponding one-sided 75% CI of 17.8 months. This median OS compared favorably to a meta-analysis of overall survival of 14.4 months (after the arrival of enzalutamide).
AB Science initiated a phase 3 study to assess the safety and efficacy of masitinib in combination with docetaxel in first line metastatic castrate resistant prostate cancer. Primary endpoint of the study is progression-free-survival (PFS).
Recruitment of the study has been completed and the study met its predefined primary endpoint.