THOUSAND OAKS, Calif.,
May 27, 2015 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that it will present data from
multiple Kyprolis® (carfilzomib) for Injection,
BLINCYTO® (blinatumomab), oprozomib and
Nplate® (romiplostim) studies at the 20th
Congress of the European Hematology Association (EHA) taking place
in Vienna, June 11 - 14, 2015. The data reinforce Amgen's
commitment to advancing the care of patients with hematologic
malignancies through the development of novel treatment approaches
and continued evaluation of marketed products.
"We focus on blood cancers that have high unmet medical need,
such as multiple myeloma and acute lymphoblastic leukemia, to make
a positive impact for patients who desperately need more options,"
said Sean E. Harper, M.D., executive
vice president of Research and Development at Amgen. "The data
being presented at EHA show advancements in understanding how novel
treatment approaches, such as Kyprolis, BLINCYTO and oprozomib, can
work across various patient populations and stages of the treatment
continuum."
Key data include findings from clinical trials in multiple
myeloma, acute lymphoblastic leukemia (ALL), Waldenström
macroglobulinemia and immune thrombocytopenia (ITP). Notable
abstracts and satellite symposia of interest include:
Kyprolis
In multiple myeloma, full results will be
presented as a late-breaking oral presentation from the Phase 3
head-to-head ENDEAVOR trial evaluating Kyprolis and dexamethasone
compared to Velcade® (bortezomib) and dexamethasone, as
well as results from the Phase 1/2 CHAMPION-1 study and a secondary
analysis from the pivotal Phase 3 ASPIRE study.
- Carfilzomib and dexamethasone improves progression-free
survival and response rates vs. bortezomib and dexamethasone in
patients with relapsed multiple myeloma: the Phase 3 study
ENDEAVOR
Abstract No. LB2071, Late-breaking Oral
Presentation, Session Title: Late-breaking Abstracts 2,
Sunday, June 14, Presentation Time:
noon - 12:15 p.m. Central European
Time (CET), Room A7
- Effect of carfilzomib, lenalidomide, and dexamethasone vs.
lenalidomide and dexamethasone in patients with relapsed multiple
myeloma by line of therapy: interim results from the Phase 3 ASPIRE
study
Abstract No. S427, Oral Presentation, Session Title:
Multiple Myeloma - Clinical Studies 2, Saturday, June 13, Presentation Time:
11:45 a.m. - noon CET, Room A2+3
- Weekly carfilzomib with dexamethasone for patients with
relapsed or refractory multiple myeloma: updated results from the
Phase 1/2 study CHAMPION-1 (NCT01677858)
Abstract No. P269,
Poster Presentation, Session Title: Multiple Myeloma - Clinical 1,
Friday, June 12, 5:15 p.m. - 6:45 p.m. CET, Poster Area (Hall
C)
- Impact of carfilzomib on health-related quality of life:
results from a Phase 2 post-hoc analysis of single-agent
carfilzomib in patients with relapsed and refractory multiple
myeloma
Abstract No. E1433, e-Poster Presentation
- Satellite Symposium: Charting new depths in the treatment of
multiple myeloma
Thursday, June
11, 4:15 p.m. - 6:15 p.m. CET,
Room C2, Messe Wien Vienna
BLINCYTO® (blinatumomab)
Blinatumomab data
at EHA will focus on targeted patient populations within
relapsed/refractory ALL to better understand response to
treatment.
- Blinatumomab safety and activity in older patients with
relapsed/refractory B-precursor acute lymphoblastic leukemia in two
Phase 2 studies
Abstract No. S115, Oral Presentation,
Session Title: ALL Clinical Trials, Friday,
June 12, Presentation Time: 12:30
p.m. - 12:45 p.m. CET, Room C1
- Retreatment with blinatumomab after CD-19-positive relapse:
experience from three trials in patients with relapsed/refractory
B-precursor acute lymphoblastic leukemia
Abstract No. P165,
Poster Presentation, Session Title: Acute Lymphoblastic Leukemia -
Clinical 1, Friday, June 12,
5:15 p.m. - 6:45 p.m. CET, Poster
Area (Hall C)
- Influence of baseline factors on outcomes in patients with
relapsed/refractory B-precursor acute lymphoblastic leukemia
treated with blinatumomab
Abstract No. P161, Poster
Presentation, Session Title: Acute Lymphoblastic Leukemia -
Clinical 1, Friday, June 12,
5:15 p.m. - 6:45 p.m. CET, Poster
Area (Hall C)
- Satellite Symposium: T-cell engagement strategies for ALL:
examining the emerging data
Thursday,
June 11, 1:30 p.m. - 3:30 p.m.
CET, Room Lehar 1 & 2, Reed Messe Vienna
Oprozomib
Updated results will be featured from three
dose escalation studies of oprozomib, a novel oral proteasome
inhibitor; one in combination with dexamethasone in patients with
relapsed and/or refractory multiple myeloma, and two as a single
agent in patients with hematologic malignancies, including multiple
myeloma and Waldenström macroglobulinemia, respectively.
- Oprozomib and dexamethasone in patients with relapsed and/or
refractory multiple myeloma: updated results from dose escalation
in a Phase 1b/2, multicenter, open-label study
Abstract No.
P653, Poster Presentation, Session Title: Multiple Myeloma -
Clinical 3, Saturday, June 13,
5:15 p.m. - 6:45 p.m. CET, Poster
Area (Hall C)
- Updated results from a multicenter, open-label, dose
escalation Phase 1b/2 study of single-agent oprozomib in patients
with hematologic malignancies, including multiple
myeloma
Abstract No. P646, Poster Presentation, Session
Title: Multiple Myeloma - Clinical 3, Saturday, June 13, 5:15
p.m. - 6:45 p.m. CET, Poster Area (Hall C)
- Updated results from a multicenter, open-label, dose
escalation Phase 1b/2 study of single-agent oprozomib in patients
with hematologic malignancies, including Waldenström
macroglobulinemia
Abstract No. E1154, e-Poster
Presentation
Nplate
Interim results from the PLATON trial, an
observational clinical practice study of Nplate in patients with
ITP, will be presented, focusing on the effect of Nplate on
platelet counts in ITP patients in clinical practice, as well as
the tolerability of Nplate.
- An observational clinical practice study of romiplostim in
patients with chronic immune thrombocytopenic purpura – PLATON
interim results
Abstract No. E1415, e-Poster
Presentation
Disease State Research
Amgen will also present a study
at EHA that focuses on trends in splenectomy in adult patients with
chronic ITP.
- Recent time trends in the uptake of splenectomy in adults
diagnosed with chronic immune thrombocytopenia: A nationwide
historical cohort study in Denmark, 1996 - 2012
Abstract No.
E1411, e-Poster Presentation
About Kyprolis® (carfilzomib) for
Injection
On July 20, 2012, the
U.S. FDA granted accelerated approval of Kyprolis for the
treatment of patients with multiple myeloma who have received at
least two prior therapies including bortezomib and an
immunomodulatory agent (IMiD) and have demonstrated disease
progression on or within 60 days of completion of the last therapy.
Approval was based on response rate. Clinical benefit, such as
improvement in survival or symptoms, has not been verified.
Kyprolis is under regulatory review by the European Medicines
Agency (EMA).
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 and Mexico. For more
information about Kyprolis, visit www.kyprolis.com.
Important Safety Information Regarding
Kyprolis® (carfilzomib) for Injection
This
safety information is specific to the current U.S. approved
indication, which is based on Phase 2 studies.
Safety data have been evaluated in 526 patients with relapsed
and/or refractory multiple myeloma who received single-agent
Kyprolis. There were 37 deaths in the Phase 2 studies, or 7 percent
of patients. The most common causes of death, other than disease
progression, were cardiac events (5 patients), end-organ failure (4
patients) and infection (4 patients). Important warnings and
precautions include cardiac arrest, congestive heart failure,
myocardial ischemia, pulmonary hypertension, pulmonary
complications, infusion reactions, tumor lysis syndrome,
thrombocytopenia, hepatic toxicity, thrombotic thrombocytopenic
purpura / hemolytic uremic syndrome (TTP/HUS), posterior reversible
encephalopathy syndrome (PRES), and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of
Kyprolis administration. Patients with New York Heart Association
Class III and IV heart failure, myocardial infarction in the
preceding 6 months and conduction abnormalities uncontrolled by
medications were not eligible for the clinical trials. These
patients may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2 percent
of patients treated with Kyprolis and was Grade 3 or greater in
less than 1 percent of patients. Dyspnea was reported in 35 percent
of patients enrolled in clinical trials. Grade 3 dyspnea occurred
in 5 percent; no Grade 4 events and 1 death (Grade 5) was
reported.
Infusion reactions, characterized by a spectrum of systemic
symptoms including fever, chills, arthralgia, myalgia, facial
flushing, facial edema, vomiting, weakness, shortness of breath,
hypotension, syncope, chest tightness, or angina can occur
immediately following or up to 24 hours after administration of
Kyprolis. Administration of dexamethasone prior to Kyprolis reduces
the incidence and severity of reactions. Tumor lysis syndrome (TLS)
occurred following Kyprolis administration in <1 percent of
patients. Patients with multiple myeloma and a high tumor burden
should be considered to be at greater risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a
dose reduction in 1 percent of patients and discontinuation of
treatment with Kyprolis in <1 percent of patients.
Cases of hepatic failure, including fatal cases, have been
reported (<1 percent). Kyprolis can cause elevations of serum
transaminases and bilirubin.
Cases of thrombotic thrombocytopenic purpura/hemolytic uremic
syndrome (TTP/HUS) including fatal outcome have been reported in
patients who received KYPROLIS.
PRES, formerly termed Reversible Posterior Leukoencephalopathy
Syndrome (RPLS), is a neurological disorder, which can present with
seizure, headache, lethargy, confusion, blindness, altered
consciousness, and other visual and neurological disturbances,
along with hypertension, and the diagnosis is confirmed by
neuro-radiological imaging (MRI). Cases of PRES have been reported
in patients receiving KYPROLIS.
There are no adequate and well-controlled studies in pregnant
women using Kyprolis. Females of reproductive potential should be
advised to avoid becoming pregnant while being treated with
Kyprolis.
The most common serious adverse reactions were pneumonia, acute
renal failure, pyrexia and congestive heart failure. The most
common adverse reactions (incidence of 30 percent or greater)
observed in clinical trials of patients with multiple myeloma were
fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea and
pyrexia. Serious adverse reactions were reported in 45 percent of
patients.
Full prescribing information is available
at www.kyprolis.com.
About BLINCYTO® (blinatumomab)
BLINCYTO is
the first FDA-approved bispecific CD19-directed CD3 T-cell engager
(BiTE®) antibody construct, and the first single-agent
immunotherapy to be approved for the treatment of patients with
Philadelphia chromosome-negative
relapsed or refractory B-cell precursor acute lymphoblastic
leukemia (ALL). Prior to approval, BLINCYTO was granted
breakthrough therapy and priority review designation by the
FDA.
Important U.S. Product Information
BLINCYTO is
indicated for the treatment
of Philadelphia chromosome-negative relapsed or
refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval.
Continued approval for this indication may be contingent upon
verification of clinical benefit in subsequent trials.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL
TOXICITIES
- Cytokine Release Syndrome (CRS), which may be
life-threatening or fatal, occurred in patients receiving BLINCYTO.
Interrupt or discontinue BLINCYTO as recommended.
- Neurological toxicities, which may be severe,
life-threatening or fatal, occurred in patients receiving BLINCYTO.
Interrupt or discontinue BLINCYTO as recommended.
Contraindications
BLINCYTO is contraindicated in
patients with a known hypersensitivity to blinatumomab or to any
component of the product formulation.
Warnings and Precautions
- Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS
occurred in patients receiving BLINCYTO. Infusion reactions have
occurred and may be clinically indistinguishable from
manifestations of CRS. Closely monitor patients for signs and
symptoms of serious events such as pyrexia, headache, nausea,
asthenia, hypotension, increased alanine aminotransferase (ALT),
increased aspartate aminotransferase (AST), increased total
bilirubin (TBILI), disseminated intravascular coagulation (DIC),
capillary leak syndrome (CLS), and hemophagocytic
lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
Interrupt or discontinue BLINCYTO as outlined in the Prescribing
Information (PI).
- Neurological Toxicities: Approximately 50% of patients
receiving BLINCYTO in clinical trials experienced neurological
toxicities. Severe, life-threatening, or fatal neurological
toxicities occurred in approximately 15% of patients, including
encephalopathy, convulsions, speech disorders, disturbances in
consciousness, confusion and disorientation, and coordination and
balance disorders. The median time to onset of any neurological
toxicity was 7 days. Monitor patients for signs or symptoms and
interrupt or discontinue BLINCYTO as outlined in the PI.
- Infections: Approximately 25% of patients receiving BLINCYTO
experienced serious infections, some of which were life-threatening
or fatal. Administer prophylactic antibiotics and employ
surveillance testing as appropriate during treatment. Monitor
patients for signs or symptoms of infection and treat
appropriately, including interruption or discontinuation of
BLINCYTO as needed.
- Tumor Lysis Syndrome (TLS): Life-threatening or fatal TLS has
been observed. Preventive measures, including pretreatment nontoxic
cytoreduction and on treatment hydration, should be used during
BLINCYTO treatment. Monitor patients for signs and symptoms of
TLS and interrupt or discontinue BLINCYTO as needed to manage these
events.
- Neutropenia and Febrile Neutropenia, including life-threatening
cases, have been observed. Monitor appropriate laboratory
parameters during BLINCYTO infusion and interrupt BLINCYTO if
prolonged neutropenia occurs.
- Effects on Ability to Drive and Use Machines: Due to the
possibility of neurological events, including seizures, patients
receiving BLINCYTO are at risk for loss of consciousness, and
should be advised against driving and engaging in hazardous
occupations or activities such as operating heavy or potentially
dangerous machinery while BLINCYTO is being administered.
- Elevated Liver Enzymes: Transient elevations in liver enzymes
are associated with BLINCYTO treatment. The majority of these
events were observed in the setting of CRS. The median time to
onset was 15 days. Grade 3 or greater elevations in liver enzymes
occurred in 6% of patients outside the setting of CRS and resulted
in treatment discontinuation in less than 1% of patients.
Monitor ALT, AST, gamma-glutamyl transferase (GGT), and TBILI prior
to the start of and during BLINCYTO treatment. BLINCYTO treatment
should be interrupted if transaminases rise to > 5 times the
upper limit of normal (ULN) or if TBILI rises to > 3 times
ULN.
- Leukoencephalopathy: Although the clinical significance is
unknown, cranial magnetic resonance imaging (MRI) changes showing
leukoencephalopathy have been observed in patients receiving
BLINCYTO, especially in patients previously treated with cranial
irradiation and anti-leukemic chemotherapy.
- Preparation and administration errors have occurred. Follow
instructions for preparation (including admixing) and
administration in the PI strictly to minimize medication errors
(including underdose and overdose).
Adverse Reactions
- The most commonly reported adverse reactions (> 20%) in
clinical trials were pyrexia (62%), headache (36%), peripheral
edema (25%), febrile neutropenia (25%), nausea (25%), hypokalemia
(23%), rash (21%), tremor (20%) and constipation (20%).
- Serious adverse reactions were reported in 65% of patients. The
most common serious adverse reactions (≥ 2%) included febrile
neutropenia, pyrexia, pneumonia, sepsis, neutropenia,
device-related infection, tremor, encephalopathy, infection,
overdose, confusion, Staphylococcal bacteremia, and headache.
Dosage and Administration Guidelines
- BLINCYTO is administered as a continuous intravenous infusion
at a constant flow rate using an infusion pump which should be
programmable, lockable, non-elastomeric, and have an alarm.
- It is very important that the instructions for preparation
(including admixing) and administration provided in the full
Prescribing Information are strictly followed to minimize
medication errors (including underdose and overdose).
Please see full Prescribing Information and medication guide for
BLINCYTO at www.BLINCYTO.com.
About Nplate® (romiplostim)
Nplate is
approved in over 50 countries worldwide, including the U.S.,
European Union (EU), Canada,
Australia, Russia, Mexico, Switzerland, Lichtenstein, Japan, Argentina, Israel, South
Korea, Hong Kong, and
Chile. Nplate also has received
orphan designation for chronic ITP in the U.S. (2003), the EU
(2005) and other parts of the world.
Nplate is the first FDA-approved treatment specifically for
adult chronic ITP. It is also being investigated for potential use
in children ages 12 months to 18 years old with persistent severe
thrombocytopenia, and chemotherapy-induced thrombocytopenia
(CIT).
In the U.S., Nplate is indicated for the treatment of
thrombocytopenia in patients with chronic ITP who have had an
insufficient response to corticosteroids, immunoglobulins or
splenectomy. Nplate is not indicated for the treatment of
thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause
of thrombocytopenia other than chronic ITP. Nplate should be
used only in patients with ITP whose degree of thrombocytopenia and
clinical condition increase the risk for bleeding. Nplate should
not be used in an attempt to normalize platelet counts.
In the EU, Nplate is indicated for the treatment of
splenectomized adult chronic ITP patients who are refractory to
other treatments (e.g., corticosteroids, immunoglobulins). Nplate
may be considered as a second-line treatment for adult
non-splenectomized ITP patients for whom surgery is
contraindicated.
Nplate was named as a recipient of the U.S. Prix Galien 2009
"Best Biotechnology Product" award and also received the 2009 Scrip
Awards for "Best New Drug." Nplate has also been honored with
numerous awards throughout the EU, including a 2010 Prix Galien in
France in the category of "Drugs
for Rare Diseases," and the 2011 Prix Galien in Germany in the category of "Specialist Care."
In September 2010, Nplate was awarded
the 2010 International Prix Galien Award, an award granted every
two years which recognizes the "best of the best" selected from
previous national Prix Galien award
recipients.
For more information about Nplate, please visit
www.Nplate.com.
Important U.S. Nplate Safety Information
The USPI for
Nplate lists the following Warnings and Precautions: The risks
associated with Nplate include progression of MDS to acute
myelogenous leukemia (AML) in patients with MDS,
thrombotic/thromboembolic complications, and lack or loss of
response to Nplate. The USPI also notes that Nplate administration
may increase the risk for development or progression of reticulin
fiber formation within the bone marrow. In the
placebo-controlled studies, headache was the most commonly reported
adverse drug reaction.
Important EU Nplate Safety Information
The EU Summary
of Product Characteristics for Nplate lists the following Special
Warnings and Precautions: Reoccurrence of thrombocytopenia and
bleeding after cessation of treatment, increased bone marrow
reticulin, thrombotic/thromboembolic complications, progression of
existing MDS (in patients with MDS), medication errors, loss of
response to Nplate, and effects on red and white blood cells.
The most common adverse reactions observed include
hypersensitivity reactions (including cases of rash, urticarial and
angioedema) and headache. As with all therapeutic proteins, there
is a potential for immunogenicity.
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.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
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we or us) and are subject to a number of risks, uncertainties and
assumptions that could cause actual results to differ materially
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significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission (SEC) reports filed by Amgen Inc., including Amgen
Inc.'s most recent annual report on Form 10-K and any subsequent
periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen
Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional
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business. Unless otherwise noted, Amgen is providing this
information as of May 27, 2015, and
expressly disclaims any duty to update information contained in
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No forward-looking statement can be guaranteed and actual
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identification of new product candidates or development of new
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CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Arvind Sood, 805-447-1060
(investors)
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