BioCentury
ARTICLE | Clinical News

Masitinib: Phase III data

November 5, 2012 8:00 AM UTC

A double-blind, international Phase III trial in 348 patients with pancreatic cancer showed that masitinib plus Gemzar gemcitabine missed the primary endpoint of median OS vs. placebo plus Gemzar (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 this population, masitinib plus Gemzar also improved OS rates at 12 months (41.4% vs. 11.1%) and 18 months (18.5% vs. 4.2%) vs. placebo plus Gemzar. 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). In the pain intensity subgroup, masitinib plus Gemzar also improved OS rates at 12 months (32.8% vs. 17.8%) and 18 months (18.2% vs. 7.8%) vs. placebo plus Gemzar. Full data has been submitted for presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco in January. AB Science could not be reached for details. ...