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JAKAVI demonstrated overall survival benefit in patients with MF1

At 5-year follow-up, patients randomised to JAKAVI arm had improved overall survival compared with patients treated with BAT1

COMFORT-II: Overall survival at 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 Verstovsek S et al. A pooled overall survival (OS) Analysis of 5-Year data from the COMFORT-I and COMFORT-II trials of ruxolitinib for the treatment of myelofibrosis (MF). Blood. 2016;128(22):3110.

  • Of the 227 patients originally randomised to BAT, 69.6% crossed over to JAKAVI during the study. In the ITT analysis of overall survival, patients who crossed over from the BAT arm to receive JAKAVI were included in the BAT group2
  • Median OS was 5.3 years in the JAKAVI arm compared with 3.8 years in the total control arm. After adjusting for crossover using an RPSFT model, there was a 65% reduction in risk of death with JAKAVI (HR=0.35; 95% CI, 0.23-0.59)2
JAKAVI is the only MF therapy that is associated with a survival benefit3

COMFORT I

  • There was a ~30% reduction in risk of death with JAKAVI compared with placebo (HR=0.69; 95% CI, 0.50-0.96; P=0.025)4

COMFORT II

  • Survival benefit with JAKAVI was evident at just 2 years (HR=0.52; 95% CI, 0.27-0.99; P=0.041)3
  • At 3.5 years, JAKAVI treatment was associated with a 65% reduction in risk of death vs BAT (HR=0.58; 95% CI, 0.36-0.93; P=0.02)5
  • At 5-year followup, there was a 33% reduction in risk of death with JAKAVI compared with BAT by ITT analysis (HR=0.67; 95% CI, 0.44-1.02; P=0.06)6

JAKAVI improved overall survival compared with placebo at 5-year follow-up4

  • 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)3
  • 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)3
  • 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)7
JAKAVI continues to provide survival improvement consistent with that observed in earlier analyses2

Next:  Well-characterised and manageable safety profile

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

References:

  1. Verstovsek S, Gupta V, Gotlib J, et al. A pooled overall survival (OS) analysis of 5-year data from the COMFORT-1 and COMFORT-II trials of ruxolitinib for the treatment of myelofibrosis (MF). Blood. 2016;128(22): 3110.
  2. Verstovsek S, Gotlib J, Mesa RA. Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses. J Hematol Oncol. 2017.10(1):156.
  3. 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.
  4. Verstovsek S, Mesa RA, Gotlib J, et al. Long-term treatment with ruxolitinib for patients with myelofibrosis: 5-year update from the randomized, double-blind, placebo-controlled, phase 3 COMFORT-I trial. J Hematol Oncol. 2017;10(1):55.
  5. 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.
  6. Harrison C, Vannuchi AM, Kiladjian J-J, et al. Long-term findings from COMFORT-II, a phase 3 study of ruxolitinib vs best available therapy for myelofibrosis. Leukemia. 2016;30(8):1701-1707.
  7. 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.