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MF
PV
  1. Efficacy
  2. Improved Prognosis

JAKAVI demonstrated overall survival benefit in patients with MF1

At 3.5-year follow-up, patients randomized to JAKAVI arm had improved overall survival compared with patients treated with BAT1

COMFORT-II: Overall survival at 3.5-year follow-up of JAKAVI vs BAT1

A significant improvement Myelofibrosis prognosis, 42% reduction in risk of death, was seen with JAKAVI, a JAK2 Inhibitor

Adapted from: Harrison C et al. Abstract presented at: 19th Congress of European Hematology Association, 2014.1
Of the 73 patients originally randomised to BAT, 45 (62%) crossed over to JAKAVI after a median duration of 66 weeks.
In the ITT analysis of overall survival, patients who crossed over from the BAT arm to receive JAKAVI were included in the BAT group.1
  • At 1-year follow-up (median: 61.1 weeks) in COMFORT-II, survival improvement was not yet evident2
  • At an unplanned 2-year analysis (median: 112 weeks), a survival trend emerged in favor of JAKAVI (HR: 0.52; 95% CI: 0.27-0.99; P=0.041)2
  • At 3.5-year follow-up, the probability of survival was 71% in the JAKAVI arm and 54% in the BAT arm (HR=0.58; 95% CI: 0.36-0.93; P=0.02)1
JAKAVI is the only MF therapy that is associated with a survival benefit2

JAKAVI improved overall survival compared with placebo at 3-year follow-up3

  • At 1-year follow-up (median: 52 and 51 weeks), JAKAVI demonstrated survival improvement (HR=0.50; 95% CI: 0.25-0.98; P=0.04)2
  • At 2-year follow-up (median: 102 weeks), JAKAVI demonstrated improved overall survival compared with placebo (HR=0.58; 95% CI: 0.36-0.95; P=0.028)2
  • At 3-year follow-up (median: 149 weeks), JAKAVI improved overall survival compared with placebo (HR=0.69; 95% CI: 0.46-1.03; P=0.067)3
JAKAVI continues to provide survival improvement consistent with that observed in earlier analyses1

Next: Well-characterised and manageable safety profile

BAT=best available therapy; COMFORT=Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment.

References:

  1. Harrison C, Niederwieser D, Vannuchi A, et al. Results from a 3.5 year update of COMFORT-II, a phase 3 study comparing ruxolitinib (RUX) with best available therapy (BAT) for the treatment of myelofibrosis. Abstract presented at: 19th Congress of the European Hematology Association; June 12-15, 2014; Milan, Italy.
  2. Mascarenhas J, Hoffman R. A comprehensive review and analysis of the effect of ruxolitinib therapy on the survival of patients with myelofibrosis. Blood. 2013;121(24):4832-4837.
  3. Verstovsek S, Mesa RA, Gotlib J, et al; for the COMFORT-I investigators. Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I. Haematologica. 2015;100(4):479-488.