Incyte Corporation INCY 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.
“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.
Coupled with the overall survival benefit observed in the ongoing Phase III
trials in myelofibrosis, these results solidify our belief in the therapeutic
opportunity that exists for Jakafi, and provide us with an acceleration
strategy to advance our JAK1 inhibitor portfolio into additional areas of
unmet medical need,” stated Paul A. Friedman, M.D., Incyte's President and
Chief Executive Officer.
Richard S. Levy, Incyte's Executive Vice President and Chief Drug Development
and Medical Officer added, “Advanced pancreatic cancer is a devastating
disease, and the RECAP study has provided us with a unique opportunity to
bring ruxolitinib forward into Phase III development in a population with no
attractive treatment options. We look forward to working with the FDA to
define the core components of the Phase III program in pancreatic cancer as
rapidly as possible, and in parallel, leveraging these results to expand our
ruxolitinib and JAK1 inhibitor programs into additional solid tumor
populations, including those that may benefit from selective JAK1 inhibition.”
Full results of the RECAP trial are expected to be presented at a future
scientific meeting.
Safety
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.
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