The European Medicines Agency (EMA) has accepted AB Science's request for authorization of the marketing of masitinib in the treatment of gastrointestinal cancer (GIST) in resistance Glivec. The accepted application based on the results of a phase II clinical study showing that masitinib improves significantly the overall survival of GIST patients resistant to Gleevec, compared to Sutent (Sunitinib) from Pfizer, which is currently the standard treatment for second-line treatment GIST.
In this study, 44 patients with GIST non-operable, locally advanced or metastatic and having a progression of the disease under treatment with Glivec (imatinib) (400 to 800 mg / day) received either masitinib (23 patients) 12mg/kg/j, either Sutent (21 patients) until disease progression. After median follow-up of 17 months, the median overall survival was not reached for masitinib while was 16 months for Sutent (Hazard Ratio: 0.27 - 95% CI [0.09, 0.78]). The overall survival estimated by the Kaplan-Meier analysis were 95.7 per cent, 81.9 per cent, and 81.9 per cent at 6, 12, and 18 months for patients masitinib, against respectively 76.2 per cent, 57.1 per cent, and 42.3 per cent for patients treated with sunitinib. Masitinib was well tolerated, with 17 per cent of patients reporting adverse events non-hematologic grade 3, compared to 62 per cent of patients in the sunitinib arm. None of the patients under masitinib reported any serious adverse events related, compared to 19 per cent of patients in the sunitinib arm.
Alain Moussy, CEO of AB Science, said, "The acceptance by the EMA to request authorization market shows that the authorities consider masitinib as a potential candidate for recording in this refractory cancer, despite the limited size of the phase II study.”
GIST is a sarcoma, a type of cancer that develops in connective tissue cells or support. The GIST occurs in the digestive tract. It is estimated that approximately 5,000 to 6,000 new patients are diagnosed with GIST each year in the United States. The global GIST therapeutic market amounted to $ 920m and is expected to grow by two per cent per year for the next seven years.
Masitinib is a tyrosine kinase inhibitor, administered orally, that targets mast cells, important immune system and a limited number of kinases that play a key role in various cancers. In Due to its novel mode of action, masitinib can be developed in a number of pathologies, oncology, inflammatory diseases and certain diseases of the central nervous system. By activity of inhibiting certain kinases that are essential in some oncogenic processes, masitinib may have an effect on tumour regression, alone or in combination with chemotherapy. Through its activity on the mast cell and certain kinases essential to the activation of inflammatory cells and fibrosing tissue remodeling, the masitinib may have an effect on the symptoms associated with some inflammatory and system central nervous system. Masitinib has received orphan drug status for the treatment of GIST by the FDA and the EMA.
AB Science is a pharmaceutical company specializing in the research, development, and commercialization of new targeted therapies for patients with cancer or other diseases with a significant unmet medical need, including inflammatory diseases and diseases of the central nervous system.