In a Phase III clinical trial, treatment of intermediate-2 or high-risk myelofibrosis with Jakafi® (ruxolitinib) improved survival and reduced spleen size. These results were published in Blood.

Myelofibrosis is a type of blood cancer known as a myeloproliferative neoplasm. It involves the abnormal development and function of bone marrow cells that produce blood cells and leads to the formation of scar tissue in the bone marrow. This can cause anemia, enlargement of the spleen and liver, fatigue, and other problems. In some patients with myelofibrosis, the condition progresses to acute myeloid leukemia.

Jakafi—approved in 2011—is currently the only drug that has been approved specifically for myelofibrosis. It is a targeted therapy known as a JAK inhibitor. Jakafi can help to relieve the signs and symptoms of myelofibrosis, such as enlargement of the spleen, night sweats, itching, and bone or muscle pain.

The current report provides long-term follow-up of a Phase III clinical trial (the COMFORT-II trial). The study enrolled 219 patients with intermediate-2 or high-risk myelofibrosis. Patients were treated with either Jakafi or best standard therapy, and have now been followed for a median of three years.

  • Patients treated with Jakafi had a 52% reduction in risk of death compared with patients treated with best standard therapy. The estimated probability of survival at three years was 81% among patients treated with Jakafi and 61% among patients treated with best standard therapy.
  • 51% of patients treated with Jakafi had at least a 35% reduction in spleen size.
  • Side effects in the Jakafi group included low blood cell counts (anemia and thrombocytopenia), but these were generally manageable.

These results provide additional evidence that Jakafi improves outcomes among patients with myelofibrosis.

Reference: Cervantes F, Vannucchi AM, Kiladjian JJ et al. Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. Blood. Early online publication October 30, 2013.

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