THOUSAND OAKS, Calif.,
Feb. 4, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced that the results of a prespecified interim analysis
showed that the primary endpoint of improved overall survival was
met in the Phase 3 TOWER study. The randomized, open-label TOWER
study evaluated the efficacy of BLINCYTO® (blinatumomab)
versus standard of care (SOC) in adult patients with Philadelphia chromosome-negative relapsed or
refractory B-cell precursor acute lymphoblastic leukemia (ALL). The
independent data monitoring committee recommended, and Amgen has
accepted, that the study end early for efficacy.
The BLINCYTO adverse events observed in the TOWER study were
consistent with the known safety profile of BLINCYTO. Secondary
endpoints are currently being evaluated. These interim data will be
submitted to a future medical conference and for publication.
"The FDA's breakthrough therapy designation and accelerated
approval of BLINCYTO underscore the dire prognosis for these
patients. This is the first study to demonstrate an overall
survival benefit for these patients with an immunotherapy, and this
is a tremendously rare achievement in relapsed and refractory ALL,"
said Sean E. Harper, M.D., executive vice president of
Research and Development at Amgen. "We will work
with regulatory authorities towards a full approval
for BLINCYTO in this population."
About TOWER Study
The TOWER study was a Phase 3, randomized, open-label study
investigating the efficacy of the BiTE® antibody
BLINCYTO versus SOC chemotherapy in adult subjects with
Philadelphia chromosome-negative
relapsed or refractory B-cell precursor ALL. Patients were
randomized in a 2:1 ratio to receive BLINCYTO or treatment with
investigator choice of one of four protocol defined SOC
chemotherapy regimens. The primary endpoint was OS. Click here to
read about the trial on ClinicalTrials.gov.
About
ALL
ALL is an aggressive cancer of the blood and bone marrow, the
spongy tissue inside bones where blood cells are made. The disease
progresses rapidly and affects immature blood cells. Patients with
ALL have abnormal white blood cells (lymphocytes) that crowd out
healthy white blood cells, red blood cells and platelets, leading
to infection, anemia (fatigue), easy bleeding and other serious
side effects.
About BLINCYTO® (blinatumomab)
BLINCYTO is a bispecific CD19-directed CD3 T cell engager
(BiTE®) antibody construct that binds specifically to
CD19 expressed on the surface of cells of B-lineage origin and CD3
expressed on the surface of T cells.
BiTE® antibody constructs are a type of immunotherapy
being investigated for fighting cancer by helping the body's immune
system to detect and target malignant cells. The modified
antibodies are designed to engage two different targets
simultaneously, thereby juxtaposing T cells (a type of white blood
cell capable of killing other cells perceived as threats) to cancer
cells. BiTE® antibody constructs help place the T cells
within reach of the targeted cell, with the intent of allowing T
cells to inject toxins and trigger the cancer cell to die
(apoptosis). BiTE® antibody constructs are currently
being investigated for their potential to treat a wide variety of
cancers.
BLINCYTO was granted breakthrough therapy and priority review
designations by the U.S. Food and Drug Administration, and is now
approved in the U.S. for the treatment of Philadelphia chromosome-negative relapsed or
refractory B-cell precursor ALL. This indication is approved under
accelerated approval. Continued approval for this indication may be
contingent upon verification of clinical benefit in subsequent
trials.
About BiTE® Technology
Bispecific T cell engager (BiTE®) antibody constructs
are a type of immunotherapy being investigated for fighting cancer
by helping the body's immune system to detect and target malignant
cells. The modified antibodies are designed to engage two different
targets simultaneously, thereby juxtaposing T cells (a type of
white blood cell capable of killing other cells perceived as
threats) to cancer cells. BiTE® antibody constructs help
place the T cells within reach of the targeted cell, with the
intent of allowing T cells to inject toxins and trigger the cancer
cell to die (apoptosis). BiTE® antibody constructs are
currently being investigated for their potential to treat a wide
variety of cancers. For more information, visit
www.biteantibodies.com.
BLINCYTO U.S. Product Safety Information
Important Safety Information Regarding BLINCYTO®
(blinatumomab) U.S. Indication
This safety information is specific to the current U.S. approved
indication.
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 have been 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 with
BLINCYTO® treatment. 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%), diarrhea (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.
U.S. 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 U.S. Prescribing Information and medication guide for
BLINCYTO at www.BLINCYTO.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.
Forward-Looking Statements
This news release contains forward-looking statements that are
based on the current expectations and beliefs of Amgen Inc. and its
subsidiaries (Amgen, we or us) and are subject to a number of
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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
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refer to Amgen Inc.'s most recent Forms 10-K, 10-Q and 8-K for
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related to our business. Unless otherwise noted, Amgen is providing
this information as of Feb. 4 2016,
and expressly disclaims any duty to update information contained in
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CONTACT:
Amgen, Thousand Oaks
Kristen Davis, 805-447-3008
(media)
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(media)
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