Jakafi success in Pancreatic Cancer Phase II trial
Incyte Corporation announced top-line results of the Phase II, randomized, double-blind, placebo-controlled RECAP trial of Jakavi/Jakafi (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 tumour responses were only observed in patients receiving ruxolitinib, and ruxolitinib treated patients achieved a significant improvement in body weight relative to placebo.
Jakavi/Jakafi is EU and FDA approved to treat Myelofibrosis.
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