Mixed Phase III results for Gilead's momelotinib in myelofibrosis

Gilead Sciences Inc. (NASDAQ:GILD) announced mixed results from two Phase III studies of momelotinib (formerly CYT387) to treat myelofibrosis. The candidate showed non-inferiority to Jakafi ruxolitinib on the SIMPLIFY-1 trial's primary endpoint, but failed to show superiority to best alternative care in SIMPLIFY-2. The company said it will discuss the data with FDA to determine next steps for the Janus kinase-1 (JAK-1) and JAK-2 inhibitor.

Gilead said the splenic response rate at week 24 (SRR24) in momelotinib-treated patients was non-inferior to that in patients receiving Jakafi (26.5% vs. 29.0%; p=0.011), meeting SIMPLIFY-1's primary endpoint. The candidate missed the secondary endpoint of non-inferior response rate as measured by total symptom score...