FDA green-lights
Topline results expected to be available by end of 2020
Study AB12003 is an international, multicenter, randomized, double blind, placebo-controlled, 2-parallel group, Phase 3 study in metastatic castrate resistant prostate cancer (mCRPC) eligible to chemotherapy. The study aims to compare the efficacy and safety of masitinib (6.0 mg/kg/day) in combination with docetaxel to placebo in combination with docetaxel. Docetaxel is combined with prednisone.
The study primary endpoint is progression free survival (PFS). A total of 468 patients are planned to be enrolled.
The target patient population consists of adult males who have progressed to develop metastatic castrate resistant prostate cancer (mCRPC) after castration treatment (i.e. reduction of available androgen/testosterone/DHT by chemical or surgical means) and are therefore eligible for chemotherapy.
An interim analysis was performed by the Independent Data Monitoring Committee (IDMC) in
About castrate-resistant prostate cancer (CRPC)
Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone. Castrate-resistant prostate cancer (CRPC) is defined by disease progression despite androgen depletion (hormone) therapy and may present as either a continuous rise in serum prostate-specific antigen (PSA) levels, the progression of pre-existing disease, and/or the appearance of new metastases. Metastatic CRPC (mCRPC) occurs when the cancer spreads to other parts of the body.
Prostate cancer is the most common cause of cancer in men, with 137.9 new cases per 100,000 men per year [1]. The estimated prevalence of people living with prostate cancer is 113 per 100,000 [2], with approximately 15% of the patients having metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy [3]. As such, population with metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy is around 75,000 in the EU and 50,000 in the
Prostate cancer is also the second most common cause of cancer death in men, with the highest rates being in
References
[1] Crawford ED, Petrylak D, Sartor O. Navigating the evolving therapeutic landscape in advanced prostate cancer. Urol Oncol. 2017 May;35S:S1-S13. doi: 10.1016/j.urolonc.2017.01.020.
[2] Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424.
[3] Scher 2015 – PLoSONE - Symptomatic mCRPC that has not been treated with or not progressed on chemotherapy
About masitinib
Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases. Based on its unique mechanism of action, masitinib can be developed in a large number of conditions in oncology, in inflammatory diseases, and in certain diseases of the central nervous system. In oncology due to its immunotherapy effect, masitinib can have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglia and consequently the inhibition of the activation of the inflammatory process, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases and the degeneration of these diseases.
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Attachment
- Prostate Cancer study Update vEng VF
Source:
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