Jakafi: Phase III data
Top-line data from the double-blind, double-dummy, international Phase III RELIEF trial in 110 patients with PV who received hydroxyurea for >=12 weeks showed twice-daily 10 mg oral ruxolitinib missed the primary endpoint of improving the proportion of patients with a >=50% reduction in TSS-C score from baseline to week 16 vs. hydroxyurea (43.4% vs. 29.6%, p=0.139). Incyte previously reported data from the Phase III RESPONSE trial in 222 patients with PV who are resistant to or intolerant of hydroxyurea showing that ruxolitinib met the primary endpoint of improving the proportion of patients achieving a response at week 32 vs. investigators’ choice of best available therapy (see BioCentury, March 10 and June 2).
In June, Incyte and Novartis submitted an sNDA to FDA and a regulatory application in the EU for ruxolitinib to treat PV patients who are resistant to or intolerant of hydroxyurea. The companies also plan to submit a regulatory application for the indication in Japan this year. Incyte said RELIEF was designed to provide additional information regarding symptom improvement and is not required for FDA approval. The company said further analysis of RELIEF is ongoing to evaluate what factors may have contributed to a symptom control rate for patients on stable doses of hydroxyurea that was 5-6 times higher than that observed in the best available therapy arm of the RESPONSE trial. ...