Date: 2014-12-18
Type of information: Results
phase: 2
Announcement: results
Company: AB Science (France)
Product: masitinib in combination with three standard-of-care chemotherapies including FOLFIRI, FOLFOX, and gemcitabine
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor. Masitinib is a tyrosine kinase inhibitor that targets mast cells, important cells for immunity, as well as a limited number of kinases that play key roles in various cancers.
Disease: nonresectable, metastatic colorectal cancer after progression to first-line treatment
Therapeutic area: Cancer - Oncology
Country:
Trial
details: This was a prospective, multicenter, open label phase 2 study testing masitinib in combination with three standard-of-care chemotherapies including FOLFIRI, FOLFOX, and gemcitabine. Primary endpoint was overall survival (OS) and secondary endpoints included progression-free survival (PFS) and overall response rate (ORR).
Latest
news: * On December 18, 2014, AB Science announced follow-up results from a phase 2 study with masitinib, in patients with nonresectable, metastatic colorectal cancer after progression to first-line treatment. AB Science has previously reported a survival benefit for masitinib plus FOLFIRI (irinotecan, 5- fluorouracil and folinic acid) in this indication based on preliminary data analysis with a median OS of 14.5 months. One year later, after a median follow-up of approximately 23 months, this survival benefit has been confirmed with a median OS of 18.0 months. Of note, approximately 50% of the masitinib plus FOLFIRI treatment cohort were positive for the KRAS mutation. These results compare favorably to published results for second-line FOLFIRI treatment in which median OS was reported as 12.5 months in patients with wild-type KRAS and 11.1 months in patients with mutant KRAS [Peeters et al. (2010) J Clin Oncol 28: 4706–4713]. The survival endpoints of PFS and ORR were also favorable for masitinib plus FOLFIRI when compared with historic benchmarks, regardless of KRAS mutation status. In the overall study population, median PFS was 6.2 months as compared with 3.9 to 4.9 months for the FOLFIRI benchmark, and ORR was 28% as compared with 10% to 14% for the FOLFIRI benchmark [Peeters et al. (2010) J Clin Oncol 28: 4706–4713]. Of significance, one patient reported a confirmed complete response, which is an exceptional observation in this clinical setting. Safety data showed that the combination of masitinib and FOLFIRI has an acceptable safety profile. Full data has been submitted for publication to the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.
