7:00AM Incyte provides top-line results from Phase II proof-of-concept trial of ruxolitinib in patients with refractory metastatic pancreatic cancer; overall survival analysis demonstrated a hazard ratio of 0.79 and a pre-specified subgroup analysis achieved a significant benefit with a hazard ratio of 0.47 (INCY) 27.00 : Co 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.
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.
