THOUSAND OAKS, Calif.,
June 15, 2019 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced the five-year overall
survival (OS) analysis from the single-arm, Phase 2 BLAST study
that evaluated BLINCYTO® (blinatumomab) in patients with
minimal residual disease (MRD)-positive acute lymphoblastic
leukemia (ALL). The study found that with a median follow-up of
59.8 months, the median OS for BLINCYTO-treated patients was 36.5
months (95 percent CI: 22 months - not estimable [NE]). More than
half of patients who achieved a complete MRD response following the
first cycle of BLINCYTO treatment were alive at five years. These
results from the largest prospective trial ever conducted in
MRD-positive ALL were presented today during an oral presentation
at the 24th Annual Congress of the European Hematology
Association (EHA) in Amsterdam.
"As the only CD19-targeted immuno-oncology therapy with
five-year survival data, BLINCYTO continues to demonstrate
compelling results for ALL patients," said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "We are proud of the science
behind our BiTE® technology. These data in an
MRD-positive ALL patient population give us increased confidence in
the clinical benefit of BLINCYTO, especially when these patients
are treated earlier."
The Phase 2 open-label BLAST study enrolled 116 patients with
MRD-positive Philadelphia
chromosome-negative (Ph-) B-cell precursor ALL in first or
subsequent complete hematologic remission after at least three
intensive chemotherapy blocks of treatment. Of the 116 enrolled
patients, OS was evaluated for 110 patients with less than five
percent leukemic blasts, including 74 patients who received
hematopoietic stem cell transplantation (HSCT) in continuous
complete remission (CCR) after BLINCYTO treatment.
Results presented at EHA showed that in 84 patients who achieved
a complete MRD response (had no measurable MRD), median OS was not
reached (95 percent CI: 29.5 months - NE) compared to 14.4 months
for those who had measurable MRD (n=23; 95 percent CI: 3.8 - 32.3
months). Among patients with MRD in first complete remission (CR1),
median OS was not reached for those who achieved a complete MRD
response (95 percent CI: 29.5 months - NE) versus 10.6 months (95
percent CI: 2.7 - 39.7 months) for those who did not achieve
complete MRD response (n=13; p=0.008).
"The presence of MRD is a strong predictor of relapse in
patients with B-cell precursor ALL," said Nicola Gökbuget, M.D.,
principal investigator for the BLAST study and head of
the German Multicenter Study Group for Adult
ALL in Frankfurt, Germany. "Results from the final follow-up of
the BLAST trial at five years demonstrate that early achievement of
complete molecular remission with BLINCYTO is associated with
prolonged survival."
Safety results among MRD-positive patients were consistent with
the known safety profile of BLINCYTO.
MRD refers to the presence of cancer cells that remain
detectable, despite a patient having achieved complete remission by
conventional assessment.1 The presence of MRD is broadly
considered the most important independent prognostic factor in
ALL.2-8 MRD is only measurable through the use of highly
sensitive testing methods that detect cancer cells in the bone
marrow with a sensitivity of at least one cancer cell in 10,000
cells – versus about one in 20 with a conventional microscope-based
evaluation.1,9,10
BLINCYTO, a bispecific CD19-directed CD3 T cell BiTE®
(bispecific T cell engager) molecule, is the first approved
molecule from Amgen's BiTE immuno-oncology platform, and the first
and only therapy to receive regulatory approval globally for the
treatment of MRD.
About the BLAST Study
The BLAST study is the largest
prospective trial in patients with MRD-positive ALL. It is an
open-label, multicenter, single-arm, Phase 2 study that evaluated
the efficacy, safety and tolerability of BLINCYTO in adult patients
with MRD-positive B-cell precursor ALL in complete hematologic
remission after three or more cycles of intensive chemotherapy.
Patients received continuous intravenous infusion of BLINCYTO 15
μg/m2/d for four weeks, followed by two weeks off.
Patients received up to four cycles of treatment and could undergo
HSCT at any time after the first cycle, if eligible. Efficacy was
based on achievement of undetectable MRD within one cycle of
BLINCYTO treatment and hematological relapse-free
survival (RFS). Results from the primary analysis BLAST study
were presented at the 57th American Society of
Hematology (ASH) Annual Meeting & Exposition in 2015 and
published in Blood in 2018. Additional secondary endpoints
included incidence and severity of adverse events, OS, time to
hematological remission and duration of complete MRD response.
Survival follow-up visits for assessment of hematological RFS and
OS took place every six months until completion of a five-year
period after treatment start with BLINCYTO. Three-year OS data
results from the BLAST study were also featured in an oral
presentation during the 60th ASH Annual Meeting &
Exposition on Dec. 3, 2018.
About ALL and MRD
ALL is a rapidly progressing cancer
of the blood and bone marrow that occurs in both adults and
children.11,12 Poor outcomes have been observed in
patients who achieve first or second complete hematologic remission
but are persistently MRD-positive, which currently remains
detectable at the molecular level after treatment.1,8
For more information about MRD, please visit
AmgenOncology.com.
About BiTE Technology
BiTE (Bispecific T
cell engager) technology is a targeted immuno-oncology platform
that is designed to engage patients' own T cells to any
tumor-specific antigen, activating the cytotoxic potential of T
cells with the goal of eliminating detectable cancer. The BiTE
immuno-oncology platform has the potential to treat different tumor
types through tumor-specific antigens. The BiTE platform has the
goal of off-the-shelf solutions, which have the potential to make
innovative T cell treatment available to all providers when their
patients need it. Amgen is advancing more than a dozen
BiTE molecules across a broad range of solid and hematologic
malignancies, further investigating BiTE technology with the goal
of enhancing patient experience and therapeutic potential.
About BLINCYTO® (blinatumomab)
BLINCYTO is a bispecific CD19-directed CD3 T cell BiTE
(bispecific T cell engager), immunotherapy that binds to CD19
expressed on the surface of cells of B-lineage origin and CD3
expressed on the surface of effector T cells. BLINCYTO was granted
breakthrough therapy and priority review designations by
the U.S. Food and Drug Administration in 2014, and carries
full approval in the U.S. for the treatment of relapsed or
refractory B-cell precursor ALL in adults and children. In the
U.S., BLINCYTO is also approved for the treatment of adults and
children with B-cell precursor ALL in first or second complete
remission with MRD greater than or equal to 0.1 percent. This
indication is approved under accelerated approval based on MRD
response rate and hematological RFS. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials. In the European Union
(EU), BLINCYTO is indicated for the treatment of adults with
Philadelphia chromosome-negative
(Ph-) relapsed or refractory B-precursor ALL and for the treatment
of Ph- CD19-positive B-cell precursor ALL in first or second
complete remission with MRD greater than or equal to 0.1
percent.
BLINCYTO is now approved in 57 countries, including all member
countries in the EU and European Economic Area, Canada, Japan
and Australia.
Important EU BLINCYTO® (blinatumomab) Safety
Information
This product is subject to additional monitoring in the EU.
All suspected adverse reactions should be reported in accordance
with the national reporting system.
The adverse reactions described in this section were identified
in clinical studies of patients with B-precursor ALL (N = 843). The
most serious adverse reactions that may occur during blinatumomab
treatment include: infections (24.8%), neurologic events (13.8%),
neutropenia/febrile neutropenia (10.1%), cytokine release syndrome
(3.3%), and tumour lysis syndrome (0.7%). The most common adverse
reactions were: pyrexia (69.2%), infusion-related reactions
(43.4%), infections – pathogen unspecified (42.1%), headache
(32.9%), anaemia (22.8%), thrombocytopenia (20.9%), febrile
neutropenia (20.2%), oedema (20.0%), neutropenia (19.7%), rash
(16.7%), increased liver hepatic enzymes (16.1%), bacterial
infectious disorders (15.4%), tremor (15.2%), cough (15.1%),
leukopenia (13.4%), back pain (13.3%), chills (13.0%), hypotension
(12.8%), viral infectious disorders (12.7%), decreased
immunoglobulins (12.5%), cytokine release syndrome (11.6%),
tachycardia (11.3%), insomnia (10.7%), fungal infectious disorders
(10.6%) and pain in extremity (10.2%).
Please refer to the Summary of Product Characteristics for
full European prescribing information.
Important Safety Information Regarding BLINCYTO®
(blinatumomab) U.S. 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): CRS, which may be
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. The median time to onset of CRS is 2 days
after the start of infusion. Closely monitor patients for signs and
symptoms of serious adverse events such as fever, headache, nausea,
asthenia, hypotension, increased alanine aminotransferase (ALT),
increased aspartate aminotransferase (AST), increased total
bilirubin (TBILI), and disseminated intravascular coagulation
(DIC). The manifestations of CRS after treatment with BLINCYTO
overlap with those of infusion reactions, capillary leak syndrome
(CLS), and hemophagocytic histiocytosis/macrophage activation
syndrome (MAS). In clinical trials of BLINCYTO, CRS was reported in
15% of patients with relapsed or refractory ALL and in 7% of
patients with MRD-positive ALL. Interrupt or discontinue
BLINCYTO® for evidence of CRS, as outlined in the
PI.
- Neurological Toxicities: Approximately 65% of patients
receiving BLINCYTO® in clinical trials experienced
neurological toxicities. The median time to the first event was
within the first 2 weeks of BLINCYTO® treatment, and the
majority of events resolved. The most common (≥ 10%) manifestations
of neurological toxicity were headache and tremor. Severe,
life‐threatening, or fatal neurological toxicities occurred in
approximately 13% of patients, including encephalopathy,
convulsions, speech disorders, disturbances in consciousness,
confusion and disorientation, and coordination and balance
disorders. Manifestations of neurological toxicity included cranial
nerve disorders. Monitor patients for signs or symptoms of
neurological toxicity and interrupt or discontinue
BLINCYTO® as outlined in the PI.
- Infections: Approximately 25% of patients receiving
BLINCYTO® in clinical trials experienced serious
infections such as sepsis, pneumonia, bacteremia, opportunistic
infections, and catheter-site 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), which may be life-threatening or
fatal, 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 (including, but not limited to, white blood cell count
and absolute neutrophil count) 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 with a
median time to onset of 3 days. In patients receiving
BLINCYTO®, although the majority of these events were
observed in the setting of CRS, some cases of elevated liver
enzymes were observed outside the setting of CRS, with a median
time to onset of 19 days. Grade 3 or greater elevations in liver
enzymes occurred in approximately 7% 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.
- Pancreatitis: Fatal pancreatitis has been reported in patients
receiving BLINCYTO® in combination with dexamethasone in
clinical trials and the post-marketing setting. Evaluate patients
who develop signs and symptoms of pancreatitis and interrupt or
discontinue BLINCYTO® and dexamethasone as needed.
- 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 antileukemic 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).
- Immunization: Vaccination with live virus vaccines is not
recommended for at least 2 weeks prior to the start of
BLINCYTO® treatment, during treatment, and until immune
recovery following last cycle of BLINCYTO®.
- Risk of Serious Adverse Reactions in Pediatric Patients due to
Benzyl Alcohol Preservative: Serious and fatal adverse reactions
including "gasping syndrome," which is characterized by central
nervous system depression, metabolic acidosis, and gasping
respirations, can occur in neonates and infants treated with benzyl
alcohol-preserved drugs including BLINCYTO® (with
preservative). When prescribing BLINCYTO® (with
preservative) for pediatric patients, consider the combined daily
metabolic load of benzyl alcohol from all sources including
BLINCYTO® (with preservative) and other drugs containing
benzyl alcohol. The minimum amount of benzyl alcohol at which
serious adverse reactions may occur is not known. Due to the
addition of bacteriostatic saline, 7-day bags of
BLINCYTO® solution for infusion with preservative
contain benzyl alcohol and are not recommended for use in any
patients weighing < 22 kg.
Adverse Reactions
- The most common adverse reactions (≥ 20%) in clinical trial
experience of patients with MRD-positive B-cell precursor ALL
(BLAST Study) treated with BLINCYTO® were pyrexia, infusion related
reactions, headache, infections (pathogen unspecified), tremor, and
chills. Serious adverse reactions were reported in 61% of patients.
The most common serious adverse reactions (≥ 2%) included pyrexia,
tremor, encephalopathy, aphasia, lymphopenia, neutropenia,
overdose, device related infection, seizure, and staphylococcal
infection.
- The most common adverse reactions (≥ 20%) in clinical trial
experience of patients with Philadelphia chromosome-negative relapsed or
refractory B-cell precursor ALL (TOWER Study) treated with
BLINCYTO® were infections (bacterial and pathogen
unspecified), pyrexia, headache, infusion-related reactions,
anemia, febrile neutropenia, thrombocytopenia, and neutropenia.
Serious adverse reactions were reported in 62% of patients. The
most common serious adverse reactions (≥ 2%) included febrile
neutropenia, pyrexia, sepsis, pneumonia, overdose, septic shock,
CRS, bacterial sepsis, device related infection, and
bacteremia.
- Adverse reactions that were observed more frequently (≥ 10%) in
the pediatric population compared to the adult population were
pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs.
24%), infusion-related reaction (49% vs. 34%), thrombocytopenia
(34% vs. 21%), leukopenia (24% vs. 11%), and weight increase (17%
vs. 6%).
- In pediatric patients less than 2 years old (infants), the
incidence of neurologic toxicities was not significantly different
than the other age groups, but its manifestations were different;
the only event terms reported were agitation, headache, insomnia,
somnolence, and irritability. Infants also had an increased
incidence of hypokalemia (50%) compared to other pediatric age
cohorts (15-20%) or adults (17%).
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, including Boxed
WARNINGS and Medication Guide, for BLINCYTO®.
About Amgen Oncology
Amgen Oncology is searching for
and finding answers to incredibly complex questions that will
advance care and improve lives for cancer patients and their
families. Our research drives us to understand the disease in the
context of the patient's life – not just their cancer journey – so
they can take control of their lives.
For the last four decades, we have been dedicated to discovering
the firsts that matter in oncology and to finding ways to reduce
the burden of cancer. Building on our heritage, Amgen continues to
advance the largest pipeline in the Company's history, moving with
great speed to advance those innovations for the patients who need
them.
At Amgen, we are driven by our commitment to transform the lives
of cancer patients and keep them at the center of everything we
do.
For more information, follow us on
www.twitter.com/amgenoncology.
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
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CONTACT: Amgen, Thousand
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