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|Incyte Announces Positive Top-Line Results from Phase III Study of Ruxolitinib in Patients with Polycythemia Vera|
“One out of four patients with polycythemia vera remain uncontrolled
despite existing standard therapies, and these patients face a profound
symptom burden and are at greater risk of cardiovascular complications.
These Phase III data give us confidence that ruxolitinib may offer a
welcome new treatment option,” stated
The global, randomized, open-label Phase III trial, called RESPONSE, was conducted at 109 sites. The trial included 222 patients with polycythemia vera resistant to or intolerant of hydroxyurea. Patients were randomized 1:1 to receive either ruxolitinib (10 mg twice-daily) or best available therapy. The dose was adjusted as needed throughout the trial.
The primary endpoint of the trial is the proportion of patients whose hematocrit level is controlled in absence of phlebotomy and whose spleen volume is reduced by 35 percent or more from baseline as assessed by imaging at 32 weeks. In addition to safety, key secondary endpoints include durable response and complete hematological remission.
Data from RESPONSE are expected to be presented at an upcoming
scientific meeting and submitted to the
About Polycythemia Vera
Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN)
characterized by an overproduction of normal red blood cells, white
blood cells and platelets that leads to an increased risk of thrombosis.1-4
Erythrocytosis (elevated red blood cell mass) is the most prominent
clinical manifestation of PV, distinguishing it from other MPNs.5
PV may occur at any age but often presents later in life, with a median
age at diagnosis of 60 years.6,7 Approximately 100,000
Although patients may be asymptomatic for many years, PV is associated with significant symptom burden, and the most common signs and symptoms of PV are fatigue, pruritus, night sweats, bone pain, fever and weight loss.11 Splenomegaly is present in 30 percent to 40 percent of patients with PV.11 In patients who experience severe and burdensome symptoms, data show that the disease causes a significant and clinically meaningful erosion of quality of life.12,13
Jakafi is a prescription medicine approved by the
Important Safety Information
Jakafi can cause serious side effects including:
Low blood counts: Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you experience unusual bleeding, bruising, fatigue, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious infection while taking Jakafi. Tell your healthcare provider if you develop symptoms such as chills, nausea, vomiting, aches, weakness, fever, or painful skin rash or blisters.
The most common side effects of Jakafi include dizziness and headache.
These are not all the possible side effects of Jakafi. Ask your healthcare provider or pharmacist for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Before taking Jakafi, tell your healthcare provider about all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had liver or kidney problems, are on dialysis, or have any other medical condition. Do not drink grapefruit juice while taking Jakafi.
Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Except for the historical information set forth herein, the matters set
forth in this press release, including without limitation, statements as
to Incyte’s confidence that ruxolitinib may offer a welcome new
treatment option for patients with uncontrolled PV and the expectation
that data from the RESPONSE trial will be presented at an upcoming
scientific meeting and submitted to the
These forward-looking statements are based on Incyte’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to the efficacy or safety of
ruxolitinib, risks related to market competition, the results of further
research and development, risks that results of clinical trials may be
unsuccessful or insufficient to meet applicable regulatory standards,
other market or economic factors and technological advances,
unanticipated delays, the ability of
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2. Marchioli R, Finazzi G, Specchia G et al. N Engl J Med. 2013;368:22-33.
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8. Data on file.
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12. Mesa RA, Niblack J, Wadleigh M, et al. Cancer. 2007;109(1):68-76.
13. Johansson P, Mesa R, Scherber R, et al. Leuk Lymphoma. 2012;53(3):441-444.