THOUSAND OAKS, Calif.,
May 26, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the Kyprolis
Global Economic Model (K-GEM)1 has been published in the
Journal of Medical Economics showing that in the United States (U.S.), Kyprolis®
(carfilzomib) in combination with lenalidomide and dexamethasone
(KRd) is cost-effective compared to lenalidomide and dexamethasone
(Rd) alone in patients with relapsed or refractory multiple
myeloma. The K-GEM demonstrated an incremental cost-effectiveness
ratio of $107,250 per
Quality-Adjusted Life Year (QALY). Kyprolis provides substantial
value when its cost per QALY is contrasted against
willingness-to-pay estimates of $150,000-$300,000 per QALY, which are cited as
reasonable benchmarks for cancer in the
U.S.2-4
"We recognize that there are different methods, assumptions and
perspectives needed to assess the value of innovation," said
Joshua Ofman, M.D., M.S.H.S., senior
vice president of Global Value and Access at Amgen. "The K-GEM was
developed with input from experts worldwide as one of the multiple
perspectives needed to assess value. Robust analysis, relying on
clinical trial data to assess cost-effectiveness analysis is one
approach that can help inform payer and provider decision-making
related to value and costs. Ultimately, individual patient
treatment decisions for diseases like multiple myeloma should be
made by doctors and their patients, based on sound clinical data
and evidence-based practice guidelines."
"Each time a patient with multiple myeloma experiences a
relapse, the ability to achieve and sustain a meaningful response
to treatment declines, so we continue to seek better ways of
treating patients with this complex disease.5 For the
healthcare system, each relapse means the disease burden and cost
of care increases," said Andrzej Jakubowiak, M.D., Ph.D., lead
author of the manuscript. "The rigorous approach taken in the K-GEM
demonstrates the economic value of the KRd regimen over standard of
care, with clear evidence of compelling value for patients, payers
and society."
The K-GEM incorporated data directly from a head-to-head
Phase 3 trial (ASPIRE) in patients with relapsed or refractory
multiple myeloma who had received one to three prior therapies. The
ASPIRE trial showed that treatment with KRd resulted in a
significant improvement (additional 8.6 months) in median
progression-free survival (PFS) compared to Rd (26.3 months
vs. 17.6 months, hazard ratio for progression or death = 0.69; 95
percent confidence interval [CI]: 0.57 to 0.83;
p<0.0001).6 The most common adverse reactions
leading to discontinuation in the KRd arm included pneumonia (1
percent), myocardial infarction (0.8 percent) and upper respiratory
tract infection (0.8 percent). A critical assumption in economic
models of cancer and also the K-GEM, where trial results have not
matured sufficiently to fully characterize the extent of survival,
is the extrapolation of overall survival. While a common
evidence-based practice in health economics, it should not be
considered a claim of extended survival.
About the Kyprolis Global Economic Model
The Kyprolis
Global Economic Model (K-GEM) provides a robust framework for
considering the value of Kyprolis in combination with lenalidomide
and dexamethasone in patients with relapsed or refractory multiple
myeloma. It was co-developed with experts worldwide over a number
of years, and has been used as the basis for a number of statutory
Health Technology Assessment analyses around the world. The K-GEM
incorporated data directly from a comparative Phase 3 trial
(ASPIRE) in patients with relapsed multiple myeloma who had
received one to three prior therapies.
About ASPIRE
The international, randomized Phase 3
ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone
versus Lenalidomide and Dexamethasone for the treatment of
PatIents with Relapsed Multiple
MyEloma) trial evaluated Kyprolis in combination with
lenalidomide and dexamethasone (KRd), versus lenalidomide and
dexamethasone (Rd) alone, in patients with relapsed multiple
myeloma following treatment with one to three prior
regimens.6 The primary endpoint of the trial was PFS,
defined as the time from treatment initiation to disease
progression or death.6 Secondary endpoints included
overall survival (OS), overall response rate (ORR), duration of
response (DOR), disease control rate, health-related quality of
life (HR-QoL) and safety.6 Patients were randomized to
receive Kyprolis (20 mg/m2 on days 1 and 2 of cycle one only,
escalating to 27 mg/m2 on days 8, 9, 15 and 16 of cycle one and
continuing on days 1, 2, 8, 9, 15 and 16 of subsequent cycles), in
addition to a standard dosing schedule of lenalidomide (25 mg per
day for 21 days on, 7 days off) and low-dose dexamethasone (40 mg
per week in four-week cycles), versus lenalidomide and low-dose
dexamethasone alone.6 The study randomized 792 patients
at sites in North America,
Europe and Israel.
About Multiple Myeloma
Multiple myeloma is an
incurable blood cancer, characterized by a recurring pattern of
remission and relapse.7 It is a disease that, in
2012, accounted for approximately one percent of all cancers
globally.8,9 In the U.S., there were more than
95,000 people living with, or in remission from, multiple myeloma
in 2013.10
About Amgen's Commitment to Oncology
Amgen Oncology is
committed to helping patients take on some of the toughest cancers,
such as those that have been resistant to drugs, those that
progress rapidly through the body and those where limited treatment
options exist. Amgen's supportive care treatments help patients
combat certain side effects of strong chemotherapy, and our
targeted medicines and immunotherapies focus on more than a dozen
different malignancies, ranging from blood cancers to solid tumors.
With decades of experience providing therapies for cancer patients,
Amgen continues to grow its portfolio of innovative and biosimilar
oncology medicines.
About Kyprolis® (carfilzomib)
Proteasomes
play an important role in cell function and growth by breaking down
proteins that are damaged or no longer needed.11
Kyprolis has been shown to block proteasomes, leading to an
excessive build-up of proteins within cells.11 In some
cells, Kyprolis can cause cell death, especially in myeloma cells
because they are more likely to contain a higher amount of abnormal
proteins.11,12 The irreversibility of Kyprolis' binding
has also been shown to offer a more sustained inhibition of the
targeted enzymes.12
Kyprolis is approved in the U.S. for the following:
- In combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- As a single agent for the treatment of patients with relapsed
or refractory multiple myeloma who have received one or more lines
of therapy.
Kyprolis is also approved in Argentina, Israel, Kuwait, Mexico, Thailand, Colombia, Korea, Canada, Switzerland and Russia and the European Union. Additional
regulatory applications for Kyprolis are underway and have been
submitted to health authorities worldwide.
For more information, please visit www.kyprolis.com.
Important Safety Information Regarding
Kyprolis® (carfilzomib) for Injection
INDICATION(S)
- KYPROLIS® (carfilzomib) is indicated in
combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- KYPROLIS® (carfilzomib) is indicated as a
single agent for the treatment of patients with relapsed or
refractory multiple myeloma who have received one or more lines of
therapy.
IMPORTANT SAFETY INFORMATION
Cardiac Toxicities
- New onset or worsening of pre-existing cardiac failure (e.g.,
congestive heart failure, pulmonary edema, decreased ejection
fraction), restrictive cardiomyopathy, myocardial ischemia, and
myocardial infarction including fatalities have occurred following
administration of KYPROLIS. Some events occurred in patients with
normal baseline ventricular function. Death due to cardiac arrest
has occurred within one day of KYPROLIS administration.
- Monitor patients for clinical signs or symptoms of cardiac
failure or cardiac ischemia. Evaluate promptly if cardiac toxicity
is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse
events until recovery, and consider whether to restart KYPROLIS at
1 dose level reduction based on a benefit/risk assessment.
- While adequate hydration is required prior to each dose in
Cycle 1, monitor all patients for evidence of volume overload,
especially patients at risk for cardiac failure. Adjust total fluid
intake as clinically appropriate in patients with baseline cardiac
failure or who are at risk for cardiac failure.
- Patients > 75 years, the risk of cardiac failure
is increased. Patients with New York Heart Association Class III
and IV heart failure, recent myocardial infarction, conduction
abnormalities, angina, or arrhythmias may be at greater risk for
cardiac complications and should have a comprehensive medical
assessment (including blood pressure and fluid management) prior to
starting treatment with KYPROLIS and remain under close
follow-up.
Acute Renal Failure
- Cases of acute renal failure and renal insufficiency adverse
events (including renal failure) have occurred in patients
receiving KYPROLIS. Acute renal failure was reported more
frequently in patients with advanced relapsed and refractory
multiple myeloma who received KYPROLIS monotherapy. Monitor renal
function with regular measurement of the serum creatinine and/or
estimated creatinine clearance. Reduce or withhold dose as
appropriate.
Tumor Lysis Syndrome
- Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes,
have occurred in patients receiving KYPROLIS. Patients with
multiple myeloma and a high tumor burden should be considered at
greater risk for TLS. Adequate hydration is required prior to each
dose in Cycle 1, and in subsequent cycles as needed. Consider uric
acid lowering drugs in patients at risk for TLS. Monitor for
evidence of TLS during treatment and manage promptly. Withhold
KYPROLIS until TLS is resolved.
Pulmonary Toxicity
- Acute Respiratory Distress Syndrome (ARDS), acute respiratory
failure, and acute diffuse infiltrative pulmonary disease such as
pneumonitis and interstitial lung disease have occurred in patients
receiving KYPROLIS. Some events have been fatal. In the event
of drug-induced pulmonary toxicity, discontinue
KYPROLIS.
Pulmonary Hypertension
- Pulmonary arterial hypertension (PAH) was reported in patients
treated with KYPROLIS. Evaluate with cardiac imaging and/or other
tests as indicated. Withhold KYPROLIS for PAH until resolved or
returned to baseline and consider whether to restart KYPROLIS based
on a benefit/risk assessment.
Dyspnea
- Dyspnea was reported in patients treated with KYPROLIS.
Evaluate dyspnea to exclude cardiopulmonary conditions including
cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3
or 4 dyspnea until resolved or returned to baseline. Consider
whether to restart KYPROLIS based on a benefit/risk
assessment.
Hypertension
- Hypertension, including hypertensive crisis and hypertensive
emergency, has been observed with KYPROLIS. Some of these events
have been fatal. Monitor blood pressure regularly in all patients.
If hypertension cannot be adequately controlled, withhold KYPROLIS
and evaluate. Consider whether to restart KYPROLIS based on a
benefit/risk assessment.
Venous Thrombosis
- Venous thromboembolic events (including deep venous thrombosis
and pulmonary embolism) have been observed with KYPROLIS.
Thromboprophylaxis is recommended for patients being treated with
the combination of KYPROLIS with dexamethasone or with lenalidomide
plus dexamethasone. The thromboprophylaxis regimen should be based
on an assessment of the patient's underlying risks.
- Patients using oral contraceptives or a hormonal method of
contraception associated with a risk of thrombosis should consider
an alternative method of effective contraception during treatment
with KYPROLIS in combination with dexamethasone or lenalidomide
plus dexamethasone.
Infusion Reactions
- Infusion reactions,
including life-threatening reactions, have occurred in
patients receiving KYPROLIS. Symptoms include fever, chills,
arthralgia, myalgia, facial flushing, facial edema, vomiting,
weakness, shortness of breath, hypotension, syncope, chest
tightness, or angina. These reactions can occur immediately
following or up to 24 hours after administration of KYPROLIS.
Premedicate with dexamethasone to reduce the incidence and severity
of infusion reactions. Inform patients of the risk and of symptoms
of an infusion reaction and to contact a physician immediately if
they occur.
Thrombocytopenia
- KYPROLIS causes thrombocytopenia with recovery to baseline
platelet count usually by the start of the next cycle.
Thrombocytopenia was reported in patients receiving KYPROLIS.
Monitor platelet counts frequently during treatment with KYPROLIS.
Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure
- Cases of hepatic failure, including fatal cases, have been
reported during treatment with KYPROLIS. KYPROLIS can cause
increased serum transaminases. Monitor liver enzymes regularly
regardless of baseline values. Reduce or withhold dose as
appropriate.
Thrombotic Microangiopathy
- Cases of thrombotic microangiopathy, including thrombotic
thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS),
including fatal outcome have occurred in patients receiving
KYPROLIS. Monitor for signs and symptoms of TTP/HUS. Discontinue
KYPROLIS if diagnosis is suspected. If the diagnosis of TTP/HUS is
excluded, KYPROLIS may be restarted. The safety of reinitiating
KYPROLIS therapy in patients previously experiencing TTP/HUS is not
known.
Posterior Reversible Encephalopathy Syndrome (PRES)
- Cases of PRES have occurred in patients receiving KYPROLIS.
PRES was formerly known as Reversible Posterior Leukoencephalopathy
Syndrome. Consider a neuroradiological imaging (MRI) for onset of
visual or neurological symptoms. Discontinue KYPROLIS if PRES is
suspected and evaluate. The safety of reinitiating KYPROLIS therapy
in patients previously experiencing PRES is not known.
Embryo-fetal Toxicity
- KYPROLIS can cause fetal harm when administered to a pregnant
woman based on its mechanism of action and findings in
animals.
- Females of reproductive potential should be advised to avoid
becoming pregnant while being treated with KYPROLIS. Males of
reproductive potential should be advised to avoid fathering a child
while being treated with KYPROLIS. If this drug is used during
pregnancy, or if pregnancy occurs while taking this drug, the
patient should be apprised of the potential hazard to the
fetus.
ADVERSE REACTIONS
- The most common adverse events occurring in at least 20 percent
of patients treated with KYPROLIS in the combination therapy
trials: anemia, neutropenia, diarrhea, dyspnea, fatigue,
thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper
respiratory tract infection, hypokalemia.
- The most common adverse events occurring in at least 20 percent
of patients treated with KYPROLIS in monotherapy trials: anemia,
fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea,
headache, cough, edema peripheral.
Please see full Prescribing Information
at www.kyprolis.com.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Forward-Looking Statement
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forward-looking statements that are based on the current
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forward-looking statements, including estimates of revenues,
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clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
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Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, Amgen is providing
this information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
Discovery or identification of new product candidates or
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candidate or development of a new indication for an existing
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Further, preclinical results do not guarantee safe and effective
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CONTACT: Amgen, Thousand
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