Phase 3 COMFORT-I Study of Ruxolitinib for Myelofibrosis
Incyte Corporation announced additional analyses of its Phase 3 COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK inhibitor Treatment) study of ruxolitinib (INC424) vs. placebo in 309 patients with myelofibrosis. Data from this randomized, double-blind, placebo-controlled trial of ruxolitinib demonstrated that treatment with ruxolitinib resulted in significant reductions in spleen volume and improvements in Total Symptom Score (TSS) while placebo-treated patients experienced progressive splenomegaly and worsening of symptoms.
The primary endpoint of a 35% reduction in spleen volume from baseline to Week 24 was associated with reduction of abdominal symptoms (abdominal discomfort, pain under the ribs and early satiety) associated with an enlarged spleen. Patient benefit also was assessed using the Patient Global Impression of Change (PGIC), which measures patients' global assessment of change in their condition on a 7-point scale ranging from “very much worse” to “very much improved.” Based on the PGIC, more than two-thirds of ruxolitinib-treated patients graded their disease as “much or very much improved” and nearly three-quarters of placebo-treated patients reported “no change” or “worsening” on that scale. Of the patients who had a 50% or greater reduction in TSS (a key secondary endpoint), nearly 90% rated their disease as “much or very much improved” based on the PGIC scale.
Ruxolitinib is an investigational Janus kinase (JAK) 1 and 2 inhibitor with potential use in hematological disorders in addition to myelofibrosis. Its NDA is currently under review by the FDA.
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