Incyte soars on positive mid-stage ruxolitinib trial results

Shares of US drug developer Incyte Corp (Nasdaq: INCY) leapt 21% to $32.55 in premarket trading yesterday (August 21) as it announced positive top-line results of the Phase II, randomized, double-blind, placebo-controlled RECAP trial of Jakafi (ruxolitinib), its oral JAK1 and JAK2 inhibitor, in combination with capecitabine (Roche’s Xeloda) 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, six month survival in the ruxolitinib arm was 42% versus 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.

First evidence of JAK inhibition activity in pancreatic cancer