Dr. Cervantes Discusses COMFORT-II Long-Term Data

Francisco Cervantes, MD, PhD, Hospital Clinic, Institut d'investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain, discusses the initial and long-term findings of the COMFORT-II trial of ruxolitinib for the treatment of myelofibrosis.

Ruxolitinib is a JAK inhibitor that showed superiority in the phase III COMFORT-I and phase III COMFORT-II trials. In the COMFORT-I trial, ruxolitinib was compared to placebo for the treatment of myelofibrosis and showed superiority in reducing spleen volume, improving symptoms, and prolonging survival and quality of life. In the parallel COMFORT-II trial, patients received ruxolitinib or best available therapy (BAT). Ruxolitinib demonstrated superior spleen volume reduction as well as myelofibrosis-related symptom reduction.

In the long-term safety, efficacy, and survival findings from the COMFORT-II trial, which Cervantes presented at the 2012 American Society of Hematology Meeting, ruxolitinib showed maintained responses and survival benefit for more than two years. The follow-up data showed that 48.3% of ruxolitinib patients achieved a ≥ 35% reduction from baseline in spleen volume at any time during the study. Since the previous report, 14% of patients receiving ruxolitinib died compared to 22% of BAT patients.