Incyte Issues Top-Line Results of Phase II PoC Trial of Ruxolitinib, Showed Hazard Ratio of 0.79

Incyte Corporation

announced top-line results of the Phase II, randomized, double-blind, placebo-controlled RECAP trial of ruxolitinib, its oral JAK1 and JAK2 inhibitor, in combination with capecitabine in patients with recurrent or treatment refractory metastatic pancreatic cancer. The hazard ratio (HR) for overall survival (OS) in the intent to treat population was 0.79 (one-sided p=0.12), and in a pre-specified subgroup analysis conducted in patients identified prospectively as most likely to benefit from JAK pathway inhibition, the HR for OS was 0.47 (one-sided p=0.005). Within this subgroup of patients, which represented 50% of the randomized population, 6 month survival in the ruxolitinib arm was 42% vs. 11% for placebo. Durable tumor responses were only observed in patients receiving ruxolitinib, and ruxolitinib treated patients achieved a significant improvement in body weight relative to placebo. “Results of the RECAP trial provide the first evidence that JAK inhibition is active in this disease and suggest a demonstrable survival benefit in a well-defined group of patients with refractory metastatic pancreatic cancer who can be identified without the development of a companion diagnostic test. Coupled with the overall survival benefit observed in the ongoing Phase III trials in myelofibrosis, these results solidify our belief in the therapeutic opportunity that exists for Jakafi, and provide us with an acceleration strategy to advance our JAK1 inhibitor portfolio into additional areas of unmet medical need,” stated Paul A. Friedman, M.D., Incyte's President and Chief Executive Officer. Richard S. Levy, Incyte's Executive Vice President and Chief Drug Development and Medical Officer added, “Advanced pancreatic cancer is a devastating disease, and the RECAP study has provided us with a unique opportunity to bring ruxolitinib forward into Phase III development in a population with no attractive treatment options. We look forward to working with the FDA to define the core components of the Phase III program in pancreatic cancer as rapidly as possible, and in parallel, leveraging these results to expand our ruxolitinib and JAK1 inhibitor programs into additional solid tumor populations, including those that may benefit from selective JAK1 inhibition.” Full results of the RECAP trial are expected to be presented at a future scientific meeting. Safety Ruxolitinib in combination with capecitabine was generally well tolerated in this study. Among patients receiving ruxolitinib plus capecitabine 12% discontinued therapy for an adverse event, compared with 20% who received capecitabine alone. The rates of new onset grade 3 anemia, thrombocytopenia or neutropenia were 16%, 2% and 0%, respectively, among patients receiving ruxolitinib plus capecitabine and were 2%, 3% and 2%, respectively, among patients receiving capecitabine alone.