Jakafi: Additional Phase III data

Additional data from the open-label, international Phase III RESPONSE trial in 222 patients with PV who are resistant to or intolerant of hydroxyurea showed that 21% of patients receiving twice-daily 10 mg oral ruxolitinib achieved the primary endpoint of a response at week 32, defined as both the absence of phlebotomy and a >=35% reduction in spleen volume, vs. 1% for patients receiving investigators' choice of best available therapy (p<0.0001). Additionally, 91% of patients receiving ruxolitinib maintained their response at week 48. Furthermore, 60% of patients receiving ruxolitinib achieved hematocrit control in the absence of phlebotomy vs. 20% for best available therapy and 38% of patients receiving ruxolitinib achieved a >=35% reduction in spleen volume vs. 1% for best available therapy. A significantly greater proportion of patients receiving ruxolitinib also achieved a complete hematologic response at week 32 vs. best available therapy (24% vs. 9%, p=0.003).

Patients receiving best available therapy who fail to meet the primary endpoint at week 32 or whose response ended prior to week 32 could cross over to receive ruxolitinib. Data were presented at the American Society of Clinical Oncology meeting in Chicago. Novartis previously reported top-line data showing that ruxolitinib met the primary endpoint (see BioCentury, March 10). Incyte and partner Novartis have an SPA from FDA for RESPONSE. In 2011, the partners amended the SPA to accelerate enrollment (see BioCentury, Aug. 8, 2011). ...