Phase III RESPONSE-2 study of Jakafi (ruxolitinib) meets primary endpoint in polycythemia vera- Incyte Corp

Incyte Corporation has announced the Phase III RESPONSE-2 study of Jakafi (ruxolitinib) met its primary endpoint in patients with polycythemia vera (PV). RESPONSE-2 is a multi-center, open label, randomized, Phase III study evaluating the efficacy and safety of ruxolitinib versus best available therapy (BAT).

Treatment with Jakafi achieved hematocrit control without the need for phlebotomy in patients with inadequately controlled polycythemia vera resistant to or intolerant of hydroxyurea who did not have an enlarged spleen, compared to BAT. The safety profile of ruxolitinib was consistent with previous studies. The results from the RESPONSE-2 study demonstrate the clinical benefits of treatment with Jakafi in PV patients without enlarged spleens and full results will be presented at a future meeting.