WILMINGTON, Del.--(BUSINESS WIRE)--Nov. 15, 2017--
Incyte Corporation (Nasdaq:INCY) today announced that the first patient
has been treated in the RESET pivotal trial evaluating ruxolitinib
(Jakafi®) compared to anagrelide for the treatment of
patients with essential thrombocythemia (ET) who are resistant to or
intolerant of hydroxyurea (HU).
“We are pleased to treat the first patient in our pivotal trial
evaluating ruxolitinib as a treatment for ET, a rare blood cancer that
can lead to life-threatening complications,” said Steven Stein, M.D.,
Chief Medical Officer, Incyte. “We look forward to building on the
clinical evidence for ruxolitinib and to advancing this trial to help
address the needs of higher-risk patients with ET, who are resistant to
or intolerant of HU and currently have limited treatment options.”
ET is a rare, chronic blood cancer, part of a group of related blood
cancers known as myeloproliferative neoplasms (MPNs), characterized by
increased platelet production, a white cell count above the normal
range, persistently elevated platelet counts with normal red blood cell
mass and the absence of prominent bone marrow fibrosis.1 An
increased platelet count can increase the risk of thrombosis. Thrombosis
can, in turn, lead to serious health problems including heart attack or
stroke. Vascular complications and transformation to myelofibrosis (MF)
or acute myeloid leukemia (AML) are the major causes of increased
morbidity and mortality in patients with ET.2,3
About the RESET Study
The randomized, double-blind, double-dummy pivotal study (NCT03123588)
is evaluating the safety and efficacy of ruxolitinib versus anagrelide
as a treatment of patients with ET. The study is expected to enroll
approximately 120 patients, 18 years or older, diagnosed with ET who are
resistant to or intolerant of HU, with a screening platelet count of
>650 × 109/L and white blood cell (WBC) count of >11.0 × 109/L.
The primary endpoint of this study is the proportion of patients who
achieve platelet and WBC control over 1 year of follow-up. Key secondary
endpoints include safety and tolerability and the proportion of patients
who achieve complete remission (CR) or partial remission (PR). For more
information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03123588.
About Jakafi® (ruxolitinib)
Ruxolitinib is a first-in-class JAK1/JAK2 inhibitor approved by the U.S.
Food and Drug Administration, as Jakafi® (ruxolitinib), 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® (ruxolitinib) 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 develop or have worsening symptoms
such as unusual bleeding, bruising, tiredness, shortness of breath, or a
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.
Increases in Cholesterol: You may have changes in your blood
cholesterol levels. Your healthcare provider will do blood tests to
check your cholesterol levels during your treatment with Jakafi.
The most common side effects of Jakafi include: low platelet
count, low red blood cell counts, 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 hepatitis B, 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, which includes a more complete
discussion of the risks associated with Jakafi, is available at www.jakafi.com.
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte, please
visit the Company’s website at www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
Forward Looking Statements
Except for the historical information set forth herein, the matters set
forth in this press release, including statements regarding the
Company’s expectations for the study evaluating ruxolitinib as a
treatment for ET, 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, 2017. Incyte disclaims any intent or obligation to update
these forward-looking statements.
Tefferi A, Thiele J, Orazi A, et al. Proposals and rationale for
revision of the World Health Organization diagnostic criteria for
polycythemia vera, essential thrombocythemia, and primary
myelofibrosis: recommendations from an ad hoc international expert
panel. Blood 2007;110:1092-109
Passamonti F, Rumi E, Arcaini L, et al. Prognostic factors for
thrombosis, myelofibrosis, and leukemia in essential
thrombocythemia: a study of 605 patients. Haematologica
Besses C, Cervantes F, Pereira A, et al. Major vascular
complications in essential thrombocythemia: a study of the
predictive factors in a series of 148 patients. Leukemia
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Source: Incyte Corporation
Catalina Loveman, +1-302-498-6171
Booth, DPhil, +1-302-498-5914