Masitinib misses Phase III OS endpoint in pancreatic cancer

AB Science S.A. (Euronext:AB) reported late Tuesday that masitinib plus Gemzar gemcitabine missed the primary endpoint of median overall survival (OS) vs. placebo plus Gemzar in a Phase III trial to treat pancreatic cancer (7.7 vs. 7 months, p=0.74). In a subgroup of patients with an undisclosed genetic biomarker that the company said is indicative of aggressive disease progression, masitinib plus Gemzar significantly improved median OS vs. placebo plus Gemzar (11 vs. 5 months, p=0.000038). In a second subgroup of patients with a pain intensity level above an undisclosed threshold at baseline, masitinib plus Gemzar also significantly improved median OS vs. placebo plus Gemzar (8.1 vs. 5.4 months, p=0.01). AB Science could not be reached for details. The double-blind, international Phase III trial enrolled 348 patients with pancreatic cancer. The company said it submitted full data for presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco in January.

AB Science also said EMA accepted for review an MAA seeking conditional approval of masitinib in combination with Gemzar to treat non-resectable, advanced adenocarcinoma pancreatic cancer. The company said the application was accepted by EMA based on the results from the two subgroups in the Phase III trial. An MAA for masitinib is also under EMA review to treat Gleevec-resistant gastrointestinal stromal tumors (GIST). Masitinib ( AB1010) is a stem cell factor ( SCF) receptor tyrosine kinase (c-Kit; KIT; CD117) inhibitor. AB Science, which released the data after the market closed, gained EUR 3.43 (22%) to EUR 18.70 on Tuesday. ...