Patients with polycythemia vera without enlarged spleen treated with
Jakafi achieved hematocrit control without phlebotomy
Incyte Corporation (Nasdaq:INCY) announces the Phase 3 RESPONSE-2 study
of Jakafi® (ruxolitinib) met its primary endpoint. Treatment
with Jakafi achieved hematocrit control without the need for phlebotomy
in patients with inadequately controlled polycythemia vera (PV)
resistant to or intolerant of hydroxyurea (HU) who did not have an
enlarged spleen, compared to best available therapy (BAT). The safety
profile of ruxolitinib was consistent with previous studies.
"The results from the RESPONSE-2 study demonstrate the clinical benefits
of treatment with Jakafi in PV patients without enlarged spleens,” said
Rich Levy, MD, Chief Drug Development Officer, Incyte. “We look forward
to further analysis of the safety and efficacy data and to sharing the
results with the scientific community and regulatory authorities in the
coming months.”
About RESPONSE-2
RESPONSE-2 is a multi-center, open label, randomized, Phase 3 study
evaluating the efficacy and safety of ruxolitinib versus BAT. The trial
randomized 149 patients with PV who are resistant to or intolerant of
HU, dependent on phlebotomy for hematocrit control and do not have an
enlarged spleen. Patients were randomized 1:1, by stratification (based
on HU-resistance or intolerance) to receive either ruxolitinib (10 mg
twice-daily) or BAT, which was defined as investigator selected
monotherapy or observation only. The dose was adjusted as needed
throughout the study.
About Polycythemia Vera
Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN) and is
typically characterized by elevated hematocrit, the volume percentage of
red blood cells in whole blood, which can lead to a thickening of the
blood and an increased risk of blood clots, as well as an elevated white
blood cell and platelet count1. Patients with PV who fail to
consistently maintain appropriate blood count levels, including
appropriate hematocrit levels, have an approximately four times higher
risk of major thrombosis (blood clots) or cardiovascular death2.
Patients with PV can also suffer from an enlarged spleen and a
significant symptom burden which may be attributed to thickening of the
blood and lack of oxygen to parts of the body3. These
symptoms commonly include fatigue, itching, night sweats, bone pain,
fever, and weight loss4.
Approximately 100,000 patients in the U.S. are living with PV5.
Current standard treatment for PV is phlebotomy (the removal of blood
from the body) plus aspirin. When phlebotomy can no longer control PV,
chemotherapy such as hydroxyurea, or interferon, is utilized6,7.
Approximately one in four patients with PV are considered uncontrolled8,9
because they have an inadequate response to or are intolerant of
hydroxyurea, the most commonly used chemotherapeutic agent for the
treatment of PV.
About Jakafi (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food
and Drug Administration, for treatment of people with polycythemia vera
(PV) who have had an inadequate response to or are intolerant of
hydroxyurea.
Jakafi is also indicated for treatment of people with intermediate or
high-risk myelofibrosis (MF), including primary MF, post–polycythemia
vera MF, and post–essential thrombocythemia MF.
Jakafi is marketed by Incyte in the United States and by Novartis as
Jakavi® (ruxolitinib) outside the United States.
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
during treatment with Jakafi. Tell your healthcare provider if you
develop any of the following symptoms of infection: chills, nausea,
vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain
types of non-melanoma skin cancers. Tell your healthcare provider if you
develop any new or changing skin lesions.
The most common side effects of Jakafi include: anemia, low
platelet count, bruising, dizziness, headache.
These are not all the possible side effects of Jakafi. Ask your
pharmacist or healthcare provider 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
tuberculosis (TB), or have been in close contact with someone who has
TB, have or had liver or kidney problems, are on dialysis, had skin
cancer or have any other medical condition. Take Jakafi exactly as your
healthcare provider tells you. Do not change or stop taking Jakafi
without first talking to your healthcare provider. Do not drink
grapefruit juice while on Jakafi.
Women should not take Jakafi while pregnant or planning to become
pregnant, or if breast-feeding.
Full Prescribing Information, including a more complete discussion of
the risks associated with Jakafi, is available at www.jakafi.com.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary therapeutics, primarily for oncology. For additional
information on Incyte, please visit the Company’s website at www.incyte.com.
Forward Looking Statements
Except for the historical information set forth herein, the matters set
forth in this press release, including statements regarding the
long-term efficacy and safety of Jakafi and the disclosure of such data,
contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments and the risks related to the efficacy or safety of the
Company’s development pipeline, 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 and competitive and technological
advances; and other risks detailed from time to time in the Company’s
reports filed with the Securities and Exchange Commission, including its
Form 10-Q for the quarter ended September 30, 2015. Incyte disclaims any
intent or obligation to update these forward-looking statements.
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1
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Leukemia & Lymphoma Society. “Polycythemia Vera Facts.” Available
at: https://www.lls.org/sites/default/files/file_assets/FS13_PolycythemiaVera_FactSheet_final5.1.15.pdf.
Accessed November 2015.
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2
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Marchioli R, Finazzi G, Specchia G, et al. Cardiovascular Events
and Intensity of Treatment in Polycythemia Vera. N Engl J Med.
2013;368:22-33.
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3
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National Institutes of Health. “What Are the Signs and Symptoms of
Polycythemia Vera?" Available at: http://www.nhlbi.nih.gov/health/health-topics/topics/poly/signs.
Accessed November 2015.
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4
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Tefferi A. Polycythemia Vera and Essential Thrombocythemia: 2013
Update on Diagnosis, Risk-Stratification, and Management. Am J
Hematol. 2013;88:507-16.
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5
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Data on file. Incyte Corporation
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6
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Vannucchi AM. How I treat polycythemia vera. Blood. 2014;
124(22):3212-20
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7
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Passamonti F. How I treat polycythemia vera. Blood. 2012;
120(2):275-84.
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8
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Barosi G, Birgegard G, Finazzi G, et al. A Unified Definition of
Clinical resistance and Intolerance to Hydroxycarbamide in
Polycythaemia Vera and Primary Myelofibrosis: Results of a European
LeukemiaNet (ELN) consensus process. Br J Haematol. 2010;149:961-3.
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9
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Alvarez-Larrán A, Pereira A, Cervantes F, et al. Assessment and
Prognostic Value of the European LeukemiaNet criteria for
Clinicohematologic Response, Resistance, and Intolerance to
Hydroxyurea in Polycythemia Vera. Blood. 2012;119:1363-9
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