- 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)
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 and suggests 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 have had 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161204005062/en/
Incyte CorporationMediaCatalina Loveman,
+1-302-498-6171cloveman@incyte.comorInvestorsMichael Booth,
DPhil, +1-302-498-5914mbooth@incyte.com
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