- Long-term treatment with Jakafi prolonged survival compared to
controls
- Data suggest that earlier treatment with Jakafi may improve
survival advantage for patients with myelofibrosis (MF)
Company Website:
http://www.incyte.com
WILMINGTON, Del. -- (Business Wire)
Incyte Corporation (Nasdaq:INCY) today announces an exploratory pooled
analysis of data from the five-year follow-up of the Phase 3 COMFORT-I
and COMFORT-II trials which further supports previously published
overall survival findings andsuggests that earlier treatment
with Jakafi® (ruxolitinib) may result in an improved survival
advantage for patients with intermediate-2 or high-risk myelofibrosis
(MF) than best available therapy (BAT) or placebo. These data also
reinforce previous long-term results observed with ruxolitinib compared
with controls (BAT or placebo).
“Understanding how earlier treatment with Jakafi may impact overall
survival for appropriate patients with myelofibrosis is critical as
physicians look to identify the most effective treatment approach for
patients with this rare and debilitating disease,” said Peg Squier,
M.D., Ph.D., Incyte’s Head of U.S. Medical Affairs.
The 5-year, intent-to-treat analysis of pooled data from two Phase 3
studies showed prolonged survival for patients with intermediate-2 or
high-risk MF randomized to ruxolitinib, with the risk of death reduced
by 30 percent for patients who received ruxolitinib compared with the
control groups. Ruxolitinib also exhibited an overall survival (OS)
advantage in various patient subgroup analyses including age, sex,
disease type, risk status, JAK2V617F mutation status, baseline spleen
length, anemia, white blood cell count, and platelet count.
Additionally, using data-modeling techniques aimed at correcting for
crossover delay, overall survival advantage was more pronounced for
patients who were randomized to receive ruxolitinib at the start of the
trial compared with patients who crossed over from control to
ruxolitinib.
These data are scheduled for presentation today at the 58th
American Society of Hematology (ASH) Annual Meeting 2016 taking place in
San Diego, California.
Results from the COMFORT-I & COMFORT-II Pooled Analysis
The double-blind COMFORT-I trial and the open-label COMFORT-II trial
were both randomized Phase 3 studies that evaluated the safety and
efficacy of ruxolitinib in 528 patients with intermediate-2 or high-risk
primary MF, post–polycythemia vera MF, or post–essential thrombocythemia
MF. Across the pooled analysis, there were a total of 301 patients
randomized to ruxolitinib (COMFORT-I, n=155; COMFORT-II, n=146), 227 to
placebo in COMFORT-I (n=154) or to BAT in COMFORT-II (n=73).
In both COMFORT-I and COMFORT-II, patients were permitted to cross over
to ruxolitinib from control treatment if they had progressive
splenomegaly or a protocol-defined progression event. Crossover was
mandatory following treatment unblinding in COMFORT 1. All continuing
patients in the control arm in COMFORT II crossed over to ruxolitinib by
the 3 year follow-up.
At the five-year intent-to-treat analysis, 42.5 percent (n=128) of the
patients randomized to the ruxolitinib group died compared with 51.5
percent (n=117) of the patients randomized to the control group. Key
findings include the following results:
-
Median overall survival for ruxolitinib was 5.3 years compared with
3.8 years for the control group.
-
Using a rank-preserving structural failure time modeling method, the
OS advantage was more pronounced for patients originally randomized to
ruxolitinib compared with patients who crossed over from control to
ruxolitinib (median OS: ruxolitinib, 5.3 y; control, 2.3 y; HR, 0.35;
95% CI, 0.23–0.59), which suggests that the delay in ruxolitinib
treatment may be the underlying reason for the difference in survival.
This analysis (Abstract #3110) is being presented as a part of a poster
session (#634) on Sunday, December 4, 2016, 6:00-8:00 PM PST, Hall GH.
About Myelofibrosis (MF)
MF is part of a group of related rare blood cancers known as
myeloproliferative neoplasms (MPNs). In MF, a patient’s bone marrow can
no longer produce enough normal blood cells, causing the spleen and or
liver to enlarge.1 MF is a progressive disease, which leads
to bone marrow scarring and significant debilitating disease-related
symptoms such as anemia, fatigue, and itching which can result in a poor
quality of life.2 Patients with MF have a decreased life
expectancy, with an average survival of approximately five to six years.3
The cause of MF is unknown but is linked to genetic mutations—between
50% and 60% of people with MF have a specific mutation of the Janus
Kinase 2 gene (JAK2).4
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 intermediate or
high-risk myelofibrosis (MF), including primary MF, post–polycythemia
vera MF, and post–essential thrombocythemia MF.
Jakafi is also indicated for treatment of people with polycythemia vera
(PV) who havehad an inadequate response to or are intolerant of
hydroxyurea.
Jakafi is marketed by Incyte in the United States and by Novartis as
Jakavi® (ruxolitinib) outside the United States. Jakafi is a
registered trademark of Incyte Corporation. Jakavi is a registered
trademark of Novartis AG in countries 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
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.
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.
About Incyte
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 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, 2016. Incyte disclaims any intent or obligation to update
these forward-looking statements.
1 Leukemia & Lymphoma Society. “Myelofibrosis Facts.”
Available at: http://www.lls.org/sites/default/files/file_assets/FS14_Myelofibrosis_Fact%20Sheet_Final9.12.pdf.
Accessed November 2015.
2 Mesa RA, Schwagera S, Radia D, et al. The Myelofibrosis
Symptom Assessment Form (MFSAF): An Evidence-based Brief Inventory to
Measure Quality of Life and Symptomatic Response to Treatment in
Myelofibrosis. Leuk Res. 2009;33:1199-1203.
3 Gangat N, Caramazza D, Vaidya R, et al. DIPSS-plus: A
Refined Dynamic International Prognostic Scoring System (DIPSS) for
Primary Myelofibrosis that Incorporates Prognostic Information from
Karyotype, Platelet Count and Transfusion Status. J Clin Oncol. 2011;
29:392-397.
4 Patriarca F, Bacigalupo A, Sperotto A, et al. Allogeneic
hematopoietic stem cell transplantation in myelofibrosis: the 20-year
experience of the Gruppo Italiano Trapianto di Midollo Osseo (GITMO).
Haematologica. 2008; 93:1514-1522.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161204005062/en/
Contacts:
Incyte Corporation
Media
Catalina Loveman,
+1-302-498-6171
cloveman@incyte.com
or
Investors
Michael
Booth, DPhil, +1-302-498-5914
mbooth@incyte.com
Source: Incyte Corporation
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