Promising Phase II Results With Ruxolitinib in Patients With Pancreatic Cancer
Overall survival improved with ruxolitinib plus capecitabine versus capecitabine alone (August 21)
Promising results have been reported from a phase 2, randomized, double-blind, placebo-controlled trial of ruxolitinib (Incyte Corporation), an 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 percent of the randomized population, 6-month survival in the capecitabine-plus-ruxolitinib arm was 42 percent versus 11 percent for the capecitabine-plus-placebo arm.
Durable tumor responses were observed only in patients receiving capecitabine and ruxolitinib, and those patients achieved a significant improvement in body weight compared with patients treated with capecitabine and placebo.
The purpose of the phase 2 RECAP trial was to determine whether ruxolitinib in combination with capecitabine could improve OS in patients with refractory metastatic pancreatic cancer compared with capecitabine alone. The study included 136 patients and consisted of an open-label, safety run-in period involving nine patients to determine the safety of the ruxolitinib-capecitabine combination. This was followed by a double-blind study of 127 patients randomly assigned to receive capecitabine plus ruxolitinib or capecitabine plus placebo.
Source: Incyte Corporation; August 21, 2013.