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June 3, 2014
10:47 EDTINCYIncyte announces results from RESPONSE trial evaluating ruxolitinib
Incyte announced results from the RESPONSE trial, the first pivotal Phase III study evaluating a JAK1/JAK2 inhibitor for the treatment of polycythemia vera. Ruxolitinib, compared to best available therapy (BAT), significantly improved hematocrit control without the need for phlebotomy and reduced spleen size in patients with uncontrolled PV. Findings from the RESPONSE study are being presented in an oral presentation at the 50th Annual Meeting of the American Society of Clinical Oncology. At a median follow-up of 81 weeks, 85% of patients in the ruxolitinib arm were still receiving treatment. Because most patients in the BAT group crossed over to receive ruxolitinib therapy at week 32, adverse events were evaluated at this time when exposure between groups was similar. The most common non-hematologic adverse events of any grade in the ruxolitinib group compared to the BAT group were headache, diarrhea, fatigue and pruritus. The company said, “One out of four patients with polycythemia vera remain uncontrolled, face a profound symptom burden and are at greater risk of cardiovascular complications such as stroke and heart attack. These Phase III data give us confidence that ruxolitinib has the potential to become an important new treatment option for patients with uncontrolled PV who are no longer responding to or are intolerant of hydroxyurea.”
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