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JAKAVI was studied in the most comprehensive clinical trial program in myelofibrosis to date1,2

COMFORT-II: Open-label, randomised, Phase III study versus BAT2,3

JAK2 Inhibitor for Myelofibrosis COMFORT-II study design - JAKAVI
  • "Real-world" comparator study— BAT included any single treatment or combination of treatments2,4
    • 34 (47%) patients received hydroxyurea
    • 49 (67%) patients received 1 or more BAT medications
    • 24 (33%) patients received no medication

Primary endpoint: Proportion of patients achieving a ≥35% reduction in spleen volume from baseline at Week 48 (as measured by MRI or CT scan)2

Secondary endpoints2:

  • Proportion of patients achieving a ≥35% reduction from baseline in spleen volume at Week 24
  • Duration of maintenance of a ≥35% reduction in spleen volume from baseline
  • Time to a reduction of ≥35% from baseline in spleen volume
  • Change in bone marrow histomorphology
  • Progression-free survival
  • Leukaemia-free survival
  • Overall survival
BAT=best available therapy; BID=twice daily; COMFORT=Controlled Myelofibrosis Study with Oral JAK Inhibitor; CT=computed tomography; MRI=magnetic resonance imaging.

References:

  1. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366(9):799-807.
  2. Harrison C, Kiladjian J-J, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012;366(9):787-798.
  3. Harrison C, Kiladjian J-J, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis [Protocol]. N Engl J Med. 2012;366(9):787-798. doi:10.1056/NEJMoa1110556.
  4. Mesa RA, Kiladjian J-J, Verstovsek S, et al. Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies. Haematologica. 2014;99(2):292-298.