12:45PM Incyte: Jakafi (ruxolitinib) continues to show improved overall survival for patients with myelofibrosis in further analyses of Phase 3 data presented at 2013 ASH (INCY) 46.14 -0.45 : Co announced today that more than 35 analyses from clinical studies of Jakafi (ruxolitinib) were presented at the 2013 American Society of Hematology (ASH) Annual Meeting from Dec. 7 to 10 in New Orleans. Jakafi, an oral JAK1/JAK2 inhibitor, is FDA-approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF). Highlights of Key Data Presented:
After a median three-year follow-up of patients in COMFORT-I, ruxolitinib treatment continued to maintain the previously reported reductions in spleen volume and improvements in quality of life measures. Overall survival favored patients originally randomized to ruxolitinib over those originally randomized to placebo (HR=0.69; 95% CI: 0.46-1.03; P=0.067). Additionally, because of the early crossover design in COMFORT-I, at the time of this analysis, patients originally randomized to placebo had been on ruxolitinib therapy a median of approximately two years, more than twice as long as their median time on placebo. Analyses were presented to show that because of the longer time these patients received Jakafi than placebo, the magnitude of the survival benefit observed may be underestimated relative to a comparison of ruxolitinib to a true placebo.
In a pooled analysis of COMFORT-I and COMFORT-II, intermediate-2-- and high-risk patients randomized to treatment with ruxolitinib had significantly prolonged survival compared to those randomized to placebo or best available therapy (HR = 0.65; 95% CI, 0.46-0.90; P = .01). Additionally, patients with high-risk myelofibrosis who were initially randomized to treatment with ruxolitinib had an estimated survival similar to patients with intermediate-2-risk myelofibrosis in the control group. Further analysis that corrects for the early crossover to ruxolitinib suggests that the survival benefit may be underestimated because patients in the placebo and best available therapy arms could cross over to receive ruxolitinib therapy. The authors also suggest that the survival benefit observed with ruxolitinib may be the result of multiple treatment effects, such as spleen volume reduction, improvement in symptoms, and improvement in nutritional status, which warrants further study.
AI
