Phase 3 study of INCB18424 for the treatment of myelofibrosis (MF)

Incyte Corporation announced positive top-line results from its Phase 3 trial of INCB18424 (also known as INC424) in patients with myelofibrosis (MF) being conducted under a FDA Special Protocol Assessment (SPA) Agreement.  This trial, known as COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment)), is a double-blind, placebo-controlled trial involving 309 patients. The primary endpoint was the response rate defined as the percentage of patients achieving a 35% or greater reduction in spleen volume at 24 weeks as measured by magnetic resonance imaging, or computerized tomography, comparing the rates in patients receiving INCB18424 or placebo. The response rate was 42% in patients randomized to INCB18424 versus less than 1% of patients randomized to placebo; thus a high level of statistical significance (p < 0.0001) was achieved. High levels of statistical significance were also achieved for the key secondary endpoints based on symptomatic improvement as measured by the modified Myelofibrosis Symptom Assessment Form Diary.

INCB18424 is a JAK1 and JAK2 inhibitor that has shown positive clinical activity in a number of hematology and inflammatory conditions.

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