Date: 2015-02-02
Type of information: Results
phase: 2
Announcement: results
Company: AB Science (France)
Product: masitinib
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor
Disease: nonresectable, metastatic esophagogastric adenocarcinoma
Therapeutic area: Cancer - Oncology
Country: France
Trial details:
Latest
news: * On February 2, 2015, AB Science announced efficacy and safety results from a phase 2 study with masitinib, in patients with nonresectable, metastatic esophagogastric adenocarcinoma after progression to first-line treatment. This was a prospective, multicenter, open-label, randomized, uncontrolled, phase 1b/2 study to evaluate efficacy and safety of masitinib in association with chemotherapy for the treatment of recurrent gastric or gastro-esophageal junction adenocarcinoma. Patients received masitinib in combination with irinotecan, or FOLFIRI (irinotecan, 5-fluorouracil and folinic acid), or 5-fluorouracil, after progression to platinum-based first-line chemotherapy. * On January 20, 2011, AB Science announced that Afssaps has granted the autorisation to start a phase 2 clinical study in stomach cancer with masitinib.
- In the masitinib plus irinotecan treatment-arm, median overall survival (OS) and progression-free survival (PFS) were 13.4 and 3.9 months, respectively. Safety data showed that the combination of masitinib and irinotecan had an acceptable safety profile.
- In the masitinib plus FOLFIRI treatment-arm, median OS and PFS were 10.9 and 2.4 months, respectively. Again, safety data showed that the combination of masitinib and FOLFIRI had an acceptable safety profile.
- The masitinib plus 5-fluorouracil treatment-arm was closed early due to lack of efficacy on PFS.
Full safety and efficacy data has been submitted for publication to the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.
The efficacy of masitinib in combination with irinotecan compares favorably to numerous published results second-line irinotecan treatment. The median OS for single-agent irinotecan has been reported at approximately 7.5 months (meta-analysis based on seven studies). Based on the efficacy data generated from this phase 2 study and the acceptable safety profile of masitinib, AB Science intends to conduct a confirmatory phase 3 trial evaluating masitinib at 6 mg/kg/day in combination with irinotecan in secondline.
