Phase III COMFORT-II study shows Jakafi/Jakavi (Novartis) improves overall survival in Myelofibrosis patients

Results from a Phase III three-year follow-up study that showed Jakafi/Jakavi (ruxolitinib), from Novartis, demonstrated improved overall survival and sustained reductions in spleen size compared to conventional therapy in patients with Myelofibrosis. In a three-year follow-up analysis of the COMFORT-II study, a 52% reduction in risk of death was observed in the ruxolitinib arm compared with conventional therapy (p=0.009), and estimated probability of overall survival was significantly greater with ruxolitinib (81% compared to 61%, respectively) at 144 weeks.

Additionally, 51.4% of patients treated with ruxolitinib achieved a >=35% reduction from baseline in spleen size. In a separate long-term exploratory Phase I/II analysis, the drug slowed or stabilized the advancement of bone marrow Fibrosis, one of the underlying disease mechanisms and consequences of Myelofibrosis, an effect that has not been observed with conventional therapy. Data was presented at the 18th Congress of European Hematology Association.