THOUSAND OAKS, Calif.,
Sept. 23, 2015 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced the presentation of
several studies evaluating Kyprolis® (carfilzomib) for
Injection, a next-generation proteasome inhibitor, at the
15th International Myeloma Workshop (IMW), from
Sept. 23-26, 2015, in Rome. Kyprolis is approved in the United States (U.S.) for use in
combination with lenalidomide and dexamethasone for the treatment
of relapsed multiple myeloma, an incurable blood cancer. In the
European Union (EU), Kyprolis is under accelerated assessment with
the European Medicines Agency (EMA).
"Multiple myeloma has historically been one of the most
difficult to treat diseases because of the inherent complexities
related to the recurring pattern of remission and relapse," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "Data to
be presented at IMW will help provide further insight into the
potential of Kyprolis as an important treatment option for patients
living with relapsed multiple myeloma."
The following Amgen-sponsored abstracts will be presented at the
meeting:
Kyprolis
- Efficacy and Safety of Carfilzomib, Lenalidomide, and
Dexamethasone (KRd) vs Lenalidomide and Dexamethasone (Rd) in
Patients (Pts) With Relapsed Multiple Myeloma (RMM) Based on Age:
Secondary Analysis From the Phase 3 Study ASPIRE
(NCT01080391)
A. Palumbo, Abstract BP-051, Friday, Sept.
25, 6:40 p.m. - 7:40 p.m.
CEST (Poster Area)
- Superior Health-Related Quality of Life with Carfilzomib,
Lenalidomide, and Dexamethasone versus Lenalidomide and
Dexamethasone in Patients With Relapsed Multiple Myeloma (MM):
Results From the ASPIRE Trial
A.K. Stewart, Abstract BP-052,
Friday, Sept. 25, 6:40 -
7:40 p.m. CEST (Poster Area)
Observational
- Survival Analysis in Newly Diagnosed Multiple Myeloma
Patients in the United States
Medicare Database
A. A. Yusuf, Abstract PO-171,
Thursday, Sept. 24, 6:40 -
7:40 p.m. CEST (Poster Area)
- Hospitalization Rates for Newly Diagnosed Multiple Myeloma
Patients in the United States
Medicare Database
A.A. Yusuf, Abstract PO-179,
Thursday, Sept. 24, 6:40 -
7:40 p.m. CEST (Poster Area)
In the U.S., Kyprolis is approved as a monotherapy and in
combination with lenalidomide and dexamethasone. In Mexico, Israel, Argentina and Thailand, Kyprolis is approved as monotherapy
for relapsed, refractory multiple myeloma. In the EU, Kyprolis is
under accelerated assessment with the EMA. The EMA application for
Kyprolis is based on data from the Phase 3 ASPIRE
(CArfilzomib, Lenalidomide, and DexamethaSone versus
Lenalidomide and Dexamethasone for the treatment of
PatIents with Relapsed Multiple
MyEloma) trial and other relevant data. The study showed
that patients treated with Kyprolis in combination with
Revlimid® (lenalidomide) and low-dose dexamethasone
(regimen referred to as KRd) lived 50 percent longer (8.7 months)
without their disease worsening compared to patients treated with
lenalidomide and low-dose dexamethasone alone (regimen referred to
as Rd). The median progression free survival was 26.3 months in
those treated with KRd compared to 17.6 months in those treated
with Rd (HR=0.69; 95 percent CI: 0.57-0.83; p<0.0001).
The most common adverse events in the Kyprolis arm included
pneumonia (1 percent), myocardial infarction (0.8 percent) and
upper respiratory tract infection (0.8 percent).
About Multiple Myeloma
Multiple myeloma is the second
most common hematologic cancer.1 Worldwide, more than
230,000 people are living with multiple myeloma with approximately
114,000 new cases diagnosed and 80,000 people dying of the disease
each year.2,3 In the U.S., there are nearly 96,000
people living with, or in remission from, multiple
myeloma.4 The estimated number of new cases of multiple
myeloma in 2014 was more than 24,000 and the estimated number of
deaths was 11,090.4 In Europe, it is estimated that more than 89,000
people are living with multiple myeloma. Approximately 39,000 new
cases were diagnosed and 24,000 people died in
2012.3
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 low-dose dexamethasone, versus lenalidomide and
low-dose dexamethasone alone, in patients with relapsed multiple
myeloma following treatment with one to three prior regimens. The
primary endpoint of the trial was progression-free survival (PFS),
defined as the time from treatment initiation to disease
progression or death. 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. Patients were randomized to receive Kyprolis (20
mg/m2 on days 1 and 2 of cycle one only, escalating to
27 mg/m2 subsquently), 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 4 week cycles),
versus lenalidomide and low-dose dexamethasone alone. In the
Kyprolis arm, patients were given a 10 minute infusion on days 1,
2, 8, 9, 15 and 16. Kyprolis was omitted on days 8 and 9 during
cycles 13-18 and not administered beyond 18 cycles.The study
randomized 792 patients at sites in North
America, Europe and
Israel.
The OS results did not cross the pre-specified early stopping
boundary for the interim analysis. At the time of the interim
analysis, there were 143 deaths (36.1 percent) in the KRd group,
compared to 162 deaths (40.9 percent) in the Rd group. The ORR was
87 percent with KRd and 67 percent with Rd. In the KRd and Rd
groups, 32 percent versus 9 percent of patients achieved a complete
response or higher (stringent complete response [sCR] or complete
response [CR]), a measurement indicating depth of response. Median
DOR was 28.6 months for patients receiving KRd (95 percent CI, 24.9
to 31.3 months) and 21.2 months for patients receiving Rd (95
percent CI, 16.7 to 25.8 months).
The rate of deaths due to adverse events (AEs) within 30 days of
the last dose was balanced between the KRd arm and the Rd arm. The
most common causes of death occurring in patients in the KRd arm
compared to the Rd arm included cardiac disorders (3 percent versus
2 percent), infection (2 percent versus 3 percent), renal (0
percent versus less than 1 percent) and other AEs (2 percent versus
3 percent). Serious AEs were reported in 60 percent of the patients
in the KRd arm and 54 percent of the patients in the Rd arm. The
most common serious AEs reported in the KRd arm compared to the Rd
arm were pneumonia (14 percent versus 11 percent), respiratory
tract infection (4 percent versus 1.5 percent), pyrexia (4 percent
versus 2 percent) and pulmonary embolism (3 percent versus 2
percent). Discontinuation due to any AE occurred in 26 percent of
patients in the KRd arm versus 25 percent of patients in the Rd
arm. Adverse events leading to discontinuation of Kyprolis occurred
in 12 percent of patients.
The ASPIRE data were presented at the 56th Annual
Meeting of the American Society of Hematology and published in
The New England Journal of Medicine in December 2014.
About Kyprolis® (carfilzomib) for
Injection
Kyprolis® (carfilzomib) for Injection
is indicated in combination with lenalidomide and dexamethasone for
the treatment of patients with multiple myeloma who have received
one to three prior lines of therapy.
Kyprolis® is also indicated under FDA accelerated
approval as a single agent for the treatment of patients with
multiple myeloma who have received at least two prior therapies
including bortezomib and an immunomodulatory agent and have
demonstrated disease progression on or within 60 days of completion
of the last therapy. Approval is based on response rate. Clinical
benefit, such as improvement in survival or symptoms, has not been
verified.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx
Pharmaceuticals is a subsidiary of Amgen and holds development and
commercialization rights to Kyprolis globally, excluding
Japan. Kyprolis is also approved
for use in Argentina, Israel, Mexico and Thailand. For more information about Kyprolis,
visit www.kyprolis.com.
Important Safety Information Regarding Kyprolis®
(carfilzomib) for Injection U.S. Indication
This safety
information is specific to the current U.S. approved
indication.
Cardiac Toxicities
New onset or worsening of
preexisting 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. Death due to cardiac arrest has occurred within a day of
Kyprolis administration.
Withhold Kyprolis for Grade 3 or 4 cardiac adverse events until
recovery, and consider whether to restart Kyprolis based on a
benefit/risk assessment.
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, and conduction abnormalities
may be at greater risk for cardiac complications.
Acute Renal Failure
Cases of acute renal failure and
renal insufficiency adverse events (renal impairment, acute renal
failure, 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. This risk was greater in patients
with a baseline reduced estimated creatinine clearance. 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 and
should be based on an assessment of the patient's underlying risks,
treatment regimen, and clinical status.
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. Reduce or withhold dose as
appropriate.
Thrombotic Thrombocytopenic Purpura / Hemolytic Uremic
Syndrome (TTP/HUS)
Cases of 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 and the
potential hazard to the fetus if Kyprolis is used during
pregnancy.
ADVERSE REACTIONS
The most common adverse events
occurring in at least 20% of patients treated with Kyprolis in
monotherapy trials: anemia, fatigue, thrombocytopenia, nausea,
pyrexia, decreased platelets, dyspnea, diarrhea, decreased
lymphocyte, headache, decreased hemoglobin, cough, edema
peripheral.
The most common adverse events occurring in at least 20% of
patients treated with Kyprolis in the combination therapy trial:
decreased lymphocytes, decreased absolute neutrophil count,
decreased phosphorus, anemia, neutropenia, decreased total white
blood cell count, decreased platelets, diarrhea, fatigue,
thrombocytopenia, pyrexia, muscle spasm, cough, upper respiratory
tract infection, decreased hemoglobin, hypokalemia.
Full prescribing information is available 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 biologics manufacturing 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.
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forward-looking statements that are based on the current
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and are subject to a number of risks, uncertainties and assumptions
that could cause actual results to differ materially from those
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noted, Amgen is providing this information as of Sept. 23, 2015, and expressly disclaims any duty
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CONTACT: Amgen, Thousand
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References
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prevalence for 27 sites in the adult population in 2008. Int J
Cancer. 2013 Mar. 1;132(5):1133-45.
doi: 10.1002/ijc.27711. Epub 2012 Jul 26.
- Ferlay J, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and
Mortality Worldwide: IARC CancerBase No. 11 [Internet].
Lyon, France: International Agency
for Research on Cancer; 2013. Available from:
http://globocan.iarc.fr, Accessed on July
27, 2015.
- Leukemia & Lymphoma Society. Facts 2014-2015. Available at:
http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/generalcancer/pdf/facts.pdf
Accessed July 2015.
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