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Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment

About COMFORT-II

COMFORT-II is a randomized, open-label Phase III study of the oral JAK1/JAK2 inhibitor INCB018424 versus best available therapy in patients with primary myelofibrosis (MF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF).

Primary endpoint

  • Proportion of subjects achieving >35% reduction in spleen volume from baseline to Week 48 as measured by MRI* (or CT† scan in applicable subjects)

Secondary endpoints

  • Leukemia-free survival
  • Overall survival
  • Progression-free survival
  • Proportion of subjects achieving a >35% reduction of spleen volume from baseline to Week 24 as measured by MRI* (or CT† scan in applicable subjects)
  • Duration of maintenance of a >35% reduction from baseline in spleen volume
  • Change in bone marrow histomorphology
* Magnetic resonance imaging.
† Computed tomography.