COMFORT-II: JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis
In this European trial, ruxolitinib shrank the spleen by more than a third in 28 percent of people with myelofibrosis after 48 weeks while no patient on the best alternative treatment achieved that, and symptoms and quality of life improved.
Overview
Open-label phase 3 trial that randomised 219 patients with intermediate-2 or high-risk primary, post-polycythaemia vera or post-essential thrombocythaemia myelofibrosis two to one to oral ruxolitinib or best available therapy. The primary endpoint was a spleen volume reduction of at least 35 percent at week 48 on MRI or CT; the key secondary endpoint was the same reduction at week 24.
28 percent of the ruxolitinib group met the primary endpoint against 0 percent on best available therapy; responses were durable and role functioning and quality of life improved, with modest toxic effects. An influence on overall survival had not been shown at the primary analysis.
- Spleen volume reduction of at least 35 percent at week 48 in 28 percent of patients on ruxolitinib versus 0 percent on best available therapy (p < 0.001).
- Durable reductions in splenomegaly and disease-related symptoms, with improved role functioning and quality of life.
- Modest toxic effects, mainly anaemia and thrombocytopenia.
With COMFORT-I, the evidence for ruxolitinib as the first approved treatment for myelofibrosis and for JAK inhibition as the standard for spleen and symptom control.
- Open-label against a heterogeneous comparator, mostly hydroxycarbamide or no treatment.
- No survival benefit was demonstrated at the primary analysis; pooled long-term follow-up later suggested one.
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