In updated results from a Phase III clinical trial, myelofibrosis patients treated with Jakafi® (ruxolitinib) continue to show reductions in spleen size and improved quality of life. These results were presented at the 2013 Annual Meeting of the American Society of Clinical Oncology.
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 results are from the Phase III Comfort-I trial. The study enrolled 309 patients with myelofibrosis who did not respond to other treatments or who were not candidates for other treatments. Patients were treated with either Jakafi or a placebo. Patients in the placebo group were allowed to start receiving Jakafi after the primary analysis or earlier if their condition worsened.
Study participants have now been followed for a median of three years.
- Patients in the Jakafi group had better overall survival than patients in the placebo group. This result did not meet the criteria for statistical significance, but this may be due to the fact that majority of patients in the placebo group were eventually treated with Jakafi.
- The previously reported benefits of Jakafi (reduced spleen size and improved quality of life) were sustained with longer-term treatment.
These results continue to demonstrate that Jakafi provides important benefits in the treatment of myelofibrosis.
Reference: Verstovsek S, Mesa RA, Gotlib J et al. Long-Term Outcomes Of Ruxolitinib Therapy In Patients With Myelofibrosis: 3-Year Update From COMFORT-I. Presented at the 55th ASH Annual Meeting and Exposition. New Orleans, LA. December 7-10, 2013. Abstract 396.
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