(Reuters) - Incyte Corp has reported an improved survival rate in a mid-stage trial in patients with refractory metastatic pancreas cancer who took its oral JAK1 and JAK2 inhibitor, called Jakafi (ruxolitinib).
In a randomized trial of capecitabine with or without Jakafi, 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), the company said in a statement.
"Within this subgroup of patients," the statement continued, "which represented 50% of the randomized population, six-month survival in the ruxolitinib arm was 42% vs. 11% for placebo."
Also, Incyte said, "Durable tumor responses were only observed in patients receiving ruxolitinib, and ruxolitinib treated patients achieved a significant improvement in body weight relative to placebo."
The combination of Jakafi and capecitabine was generally well tolerated in the study.
Among the patients receiving the combination therapy, 12% discontinued treatment for an adverse event, compared with a 20% rate among patients who received capecitabine alone.
"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," stated Paul A. Friedman, M.D., Incyte's President and Chief Executive Officer.
Jakafi is already approved in the United States to treat intermediate or high-risk myelofibrosis.
Swiss drugmaker Novartis AG markets the drug outside the U.S. as Jakavi.
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