“RELIEF was designed to provide us with additional information regarding symptom improvement and is not required for
Further analyses of RELIEF are underway to evaluate what factors may have contributed to a symptom control rate for patients on stable doses of HU that was five to six times higher than that seen in the best available therapy control arm of the RESPONSE trial, and which led to an underpowering of the RELIEF trial.
RESPONSE was an open-label randomized trial of 222 patients and is the basis of Incyte’s supplemental New Drug Application (sNDA) submitted in
HervÉ Hoppenot, President and CEO of
About RELIEF (Randomized Switch Study from Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms)
RELIEF is a Phase III multicenter, double-blind, double-dummy, randomized (1:1) study involving 110 PV patients. Eligible patients were required to have a confirmed diagnosis of PV according to the revised
The primary endpoint of the study was the proportion of subjects with = 50% reduction in TSS-C, measured using a patient questionnaire, at week 16 compared to baseline.
About RESPONSE (Randomized Study of Efficacy and Safety in POlycythemia Vera with Jak INhibitor INCB018424 VerSus BEst Available Care)
RESPONSE is an open-label randomized trial of 222 patients conducted in
The primary endpoint of the study is the proportion of patients who achieved both hematocrit control without the need for phlebotomy from week 8 through 32 and a spleen volume reduction of at least 35 percent from baseline at 32 weeks. Key secondary endpoints include durable primary response and complete hematologic remission. Complete hematologic remission was defined as maintaining hematocrit control without the need for phlebotomy, a platelet count =400 x 109/L and white blood cell count =10 x 109/
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 patients in
About Jakafi® (ruxolitinib)
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.
Please see the Full Prescribing Information available at www.jakafi.com, which includes a more complete discussion of the risks associated with Jakafi.
Except for the historical information set forth herein, the matters set forth in this press release, including without limitation statements with respect to the potential efficacy, safety and therapeutic value of, and Incyte’s plans and expectations for, ruxolitinib in polycythemia vera, including the potential for ruxolitinib to become the first JAK1/JAK2 inhibitor available for patients with polycythemia vera and an important new treatment for patients with polycythemia vera who are no longer responding to or are intolerant of hyroxyurea, and the expectation to present full data from the RELIEF trial at an upcoming scientific meeting, contain predictions and estimates and are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. 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, the results of further analyses of trial results, the results of further research and development, the high degree of risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, other market or economic factors, competitive and technological advances, and other risks detailed from time to time in
1. Vannucchi AM, Guglielmelli P, Tefferi A. CA Cancer J Clin. 2009;59:171-91.
2. Marchioli R, Finazzi G, Specchia G, et al. N Engl J Med. 2013;368:22-33.
3. Tefferi A. Am J Hematol. 2013;88:507-16.
4. Spivak JL. Blood. 2002;100:4272-90.
5. Spivak JL. Ann Intern Med. 2010;152:300-6.
6. Tefferi A, Rumi E, Finazzi G, et al. Leukemia. 2013;27:1874-81.
7. Gruppo Italiano Studio Policitemia. Ann Intern Med. 1995;123:656-64.
8. Data on file.
9. Barosi G, Birgegard G, Finazzi G, et al. Br
10. Alvarez-LarrÁn A, Pereira A, Cervantes F, et al. Blood. 2012;119:1363-9
Vice President, Investor Relations & Corporate Communications