Phase 3 Study Results Demonstrated Three Year,
Disease-Free Survival of 96%
THOUSAND
OAKS, Calif., Dec. 7, 2024
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data
demonstrating that adding BLINCYTO® (blinatumomab) to
chemotherapy significantly improves disease-free survival (DFS) in
newly diagnosed pediatric patients with National Cancer Institute
(NCI) standard risk (SR) B-cell acute lymphoblastic leukemia
(B-ALL) of average or higher risk of relapse. The data are from a
Phase 3 study (AALL1731) conducted by the Children's Oncology
Group. The results were simultaneously published in the New
England Journal of Medicine and will be presented during the
plenary session on Sunday, Dec. 8, at
2 p.m. PT at the 66th
American Society of Hematology (ASH) Annual Meeting &
Exposition in San Diego.
"Over the last decade, BLINCYTO has reshaped the treatment
landscape for B-ALL, offering a critical lifeline for thousands of
adult and pediatric patients," said Jay
Bradner, M.D., executive vice president of Research and
Development and chief scientific officer at Amgen. "These powerful
new data leave us little doubt about the profound impact of this
medicine for a large number of children affected by this disease.
We are grateful to the Children's Oncology Group, along with the
patients, families and clinical teams, for their dedication and
partnership in advancing this critical study to improve the lives
of children with cancer."
Based on the results of the first pre-specified interim analysis
for efficacy, the study met its primary endpoint of DFS and study
randomization was terminated early based on the recommendation from
the data and safety monitoring committee due to the benefit
observed in the BLINCYTO arm compared to the chemotherapy-only arm.
Overall, the 3-year DFS was 96.0% for patients treated with
chemotherapy plus BLINCYTO compared to 87.9% for those treated with
only chemotherapy. The hazard ratio (HR) was 0.39 [95% confidence
interval (CI) 0.24-0.64], indicating a 61% reduction in the risk of
disease relapse, secondary malignant neoplasm or remission death
with BLINCYTO. At 3 years, more patients remained alive and cancer
free when treated with BLINCYTO plus chemotherapy compared to
chemotherapy alone.
"The AALL1731 study results are truly practice-changing, further
solidifying blinatumomab's role as the standard of care for a large
number of children with B-ALL," said Sumit
Gupta, M.D., Ph.D., FRCPC, co-chair of the Children's
Oncology Group AALL1731 study and oncologist and clinician
investigator, Division of Haematology/Oncology at The Hospital for
Sick Children (SickKids) and associate professor of pediatrics at
the University of Toronto. "These
breakthrough data showing a significant improvement in disease-free
survival are poised to bring substantial clinical value to children
with newly diagnosed B-ALL."
The addition of BLINCYTO to chemotherapy in standard risk
patients resulted in outcomes similar to those previously achieved
in only the most favorable pediatric risk subsets. Among SR-Average
patients, 3-year DFS was 97.5% for patients treated with BLINCYTO
compared to 90.2% for those treated with only chemotherapy (HR
0.33, CI 0.15-0.69). For SR-High patients, 3-year DFS was 94.1% for
those treated with BLINCYTO compared to 84.8% for those treated
with only chemotherapy (HR 0.45, 95% CI 0.24-0.85).
"Relapsed ALL remains a major cause of pediatric cancer
mortality, with nearly half of the relapses occurring in children
with standard-risk B-ALL," said Rachel E.
Rau, M.D., co-chair of the Children's Oncology Group
AALL1731 study, pediatric hematologist-oncologist at Seattle
Children's Hospital and associate professor of pediatrics at the
University of Washington. "These
findings underscore the progress made with blinatumomab in
preventing relapse and support its role as a critical addition to
current therapeutic strategies."
Safety results are consistent with the known safety profile of
BLINCYTO. BLINCYTO has demonstrated a positive balance of benefits
and risks, with only 0.3% of first courses associated with Grade 3+
cytokine release syndrome (CRS) and 0.7% with seizures. A higher
risk of infections was observed in the BLINCYTO arm.
These results provide the first evidence supporting BLINCYTO for
use in the consolidation phase in newly diagnosed pediatric
Philadelphia chromosome-negative
(Ph-) B-ALL patients. This groundbreaking first-in-class Bispecific
T-cell Engager (BiTE®) therapy is now backed by
additional evidence reinforcing its role in redefining a standard
of care for both adult and pediatric patients, starting from one
month old, regardless of measurable residual disease (MRD) status.
The findings further establish BLINCYTO as a versatile first-line
consolidation therapy across all ages and treatment
backbones.
The NCI's Cancer Therapy Evaluation Program (CTEP), which
sponsored the study will share data with the U.S. Food and Drug
Administration as part of their ongoing communications relating to
the trial.
About The Children's Oncology Group
The Children's
Oncology Group (childrensoncologygroup.org), a member of the NCI
National Clinical Trials Network (NCTN), is the world's largest
organization devoted exclusively to childhood and adolescent cancer
research. The Children's Oncology Group unites over 10,000 experts
in childhood cancer at more than 200 leading children's hospitals,
universities and cancer centers across North America, Australia, New
Zealand and Saudi Arabia in
the fight against childhood cancer. Today, more than 80% of the
15,000 children and adolescents diagnosed with cancer each year in
the United States are cared for at
Children's Oncology Group member institutions. Research performed
by Children's Oncology Group institutions over the past 50 years
has transformed childhood cancer from a virtually incurable disease
to one with a combined 5-year survival rate of 86%. The Children's
Oncology Group's mission is to improve the cure rate and outcomes
for all children with cancer.
About AALL1731 (NCT03914625)
The AALL1731 study was a
Phase 3 randomized trial to determine if two non-sequential cycles
of BLINCYTO added to chemotherapy improved disease-free survival
(DFS) in children with newly diagnosed pediatric National Cancer
Institute (NCI) standard risk (SR) B-cell acute lymphoblastic
leukemia (B-ALL). The study enrolled 4,264 newly diagnosed NCI SR
B-ALL patients, of whom 2,334 were risk stratified at the end of
induction therapy as either SR-Average or SR-High. At the first
planned interim efficacy analysis (data cutoff June 30, 2024), 1,440 of the eligible and
evaluable patients had been randomized.
The AALL1731 study was designed and conducted independently from
industry. The Cancer Therapy Evaluation Program (CTEP) of the NCI
sponsored the trial and provided funding to the Children's Oncology
Group to conduct the study. NCI is part of the National Institutes
of Health (NIH). In addition, Amgen provided BLINCYTO and support
through an NCI Cooperative Research and Development Agreement.
About Acute Lymphoblastic Leukemia (ALL)
ALL, also
known as acute lymphoblastic leukemia, is a fast-growing type
of blood cancer that develops in the bone marrow and can sometimes
spread to other parts of the body, including the lymph nodes,
liver, spleen and central nervous system. ALL is a rare disease,
with an estimated 6,550 new cases, affecting both children and
adults, diagnosed in the U.S. in
2024.1 B-ALL begins in immature cells that would
normally develop into B-cell lymphocytes, which are white blood
cells that grow in bone marrow.2,3 B-ALL is the
most common type of ALL, constituting approximately 75% of cases in
adults and approximately 88% in children, the most common cancer in
children.4,5
About BLINCYTO®
(blinatumomab)
BLINCYTO is the first globally approved
Bispecific T-cell Engager (BiTE®) immuno-oncology
therapy that targets CD19 surface antigens on B
cells. BiTE® molecules fight cancer by helping
the body's immune system detect and target malignant cells by
engaging T cells (a type of white blood cell capable of killing
other cells perceived as threats) to cancer cells. By bringing T
cells near cancer cells, the T cells can inject toxins and trigger
cancer cell death (apoptosis).
BiTE® immuno-oncology therapies 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. FDA and is approved in
the U.S. for the treatment of:
- Adult and pediatric patients one month or older with
CD19-positive Philadelphia chromosome-negative B-ALL
during the consolidation phase of multiphase therapy.
- CD19-positive B-ALL in first or second complete remission with
MRD greater than or equal to 0.1% in adults and pediatric patients
one month or older.
- Relapsed or refractory CD19-positive B-ALL in adults and
pediatric patients one month or older.
In the European Union (EU), BLINCYTO is indicated as
monotherapy for the treatment of:
- Adults with Philadelphia chromosome-negative
CD19-positive relapsed or refractory B-ALL. Patients
with Philadelphia chromosome-positive B-ALL should have
failed treatment with at least two tyrosine kinase inhibitors
(TKIs) and have no alternative treatment options.
- Adults with Philadelphia chromosome-negative
CD19-positive B-ALL in first or second complete remission with MRD
greater than or equal to 0.1%.
- Pediatric patients aged 1 year or older
with Philadelphia chromosome-negative CD19-positive B-ALL
which is refractory or in relapse after receiving at least two
prior therapies or in relapse after receiving prior allogeneic
hematopoietic stem cell transplantation.
- Pediatric patients aged 1 year or older with high-risk first
relapsed Philadelphia chromosome-negative CD19-positive
B-ALL as part of the consolidation therapy.
BLINCYTO® IMPORTANT SAFETY
INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL
TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY
SYNDROME
- Cytokine Release Syndrome (CRS), which may be
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. Interrupt or
discontinue BLINCYTO® and treat with
corticosteroids as recommended.
- Neurological toxicities, including immune effector
cell-associated neurotoxicity syndrome (ICANS) 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 and the median time to resolution of
CRS was 5 days among cases that resolved. Closely monitor and
advise patients to contact their healthcare professional 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). Using all of
these terms to define CRS in clinical trials of
BLINCYTO®, CRS was reported in 15% of patients with R/R
ALL, in 7% of patients with MRD-positive ALL, and in 16% of
patients receiving BLINCYTO® cycles in the
consolidation phase of therapy. If severe CRS occurs, interrupt
BLINCYTO® until CRS resolves. Discontinue
BLINCYTO® permanently if life-threatening CRS
occurs. Administer corticosteroids for severe or life-threatening
CRS.
- Neurological Toxicities, including Immune Effector
Cell-Associated Neurotoxicity
Syndrome: BLINCYTO® can cause serious or
life-threatening neurologic toxicity, including ICANS. The
incidence of neurologic toxicities in clinical trials was
approximately 65%. The median time to the first event was within
the first 2 weeks of BLINCYTO® treatment. The
most common (≥ 10%) manifestations of neurological toxicity were
headache and tremor. Grade 3 or higher 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. The majority of neurologic toxicities
resolved following interruption of BLINCYTO®, but some
resulted in treatment discontinuation.
The incidence of signs and symptoms consistent with ICANS in
clinical trials was 7.5%. The onset of ICANS can be concurrent with
CRS, following resolution of CRS, or in the absence of CRS. There
is limited experience with BLINCYTO® in patients
with active ALL in the central nervous system (CNS) or a history of
neurologic events. Patients with a history or presence of
clinically relevant CNS pathology were excluded from clinical
studies. Patients with Down Syndrome over the age of 10 years may
have a higher risk of seizures with
BLINCYTO® therapy.
Monitor patients for signs and symptoms of neurological toxicities,
including ICANS, and interrupt or discontinue
BLINCYTO® as outlined in the PI. Advise outpatients
to contact their healthcare professional if they develop signs or
symptoms of neurological toxicities.
- 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 and
ICANS, 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, and total blood bilirubin 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 total bilirubin 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®.
- Benzyl Alcohol Toxicity in Neonates: Serious
adverse reactions, including fatal reactions and the "gasping
syndrome," have been reported in very low birth weight (VLBW)
neonates born weighing less than 1500 g, and early preterm neonates
(infants born less than 34 weeks gestational age) who received
intravenous drugs containing benzyl alcohol as a preservative.
Early preterm VLBW neonates may be more likely to develop these
reactions, because they may be less able to metabolize benzyl
alcohol.
Use the preservative-free preparations of
BLINCYTO® where possible in neonates. When
prescribing BLINCYTO® (with preservative) for
neonatal patients, consider the combined daily metabolic load of
benzyl alcohol from all sources including
BLINCYTO® (with preservative), other products
containing benzyl alcohol or other excipients (e.g., ethanol,
propylene glycol) which compete with benzyl alcohol for the same
metabolic pathway.
Monitor neonatal patients receiving BLINCYTO® (with
preservative) for new or worsening metabolic acidosis. The minimum
amount of benzyl alcohol at which serious adverse reactions may
occur in neonates is not known. The BLINCYTO® 7-Day
bag (with preservative) contains 7.4 mg of benzyl alcohol per
mL.
- Embryo-Fetal Toxicity: Based on its mechanism of
action, BLINCYTO® may cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the
potential risk to the fetus. Advise females of reproductive
potential to use effective contraception during treatment with
BLINCYTO® and for 48 hours after the last
dose.
Adverse Reactions
- The safety of BLINCYTO® in adult and pediatric
patients one month and older with MRD-positive B-cell precursor ALL
(n=137), relapsed or refractory B-cell precursor ALL (n=267),
and Philadelphia chromosome-negative B-cell precursor ALL
in consolidation (n=165) was evaluated in clinical studies. The
most common adverse reactions (≥ 20%)
to BLINCYTO® in this pooled population were
pyrexia, infusion-related reactions, headache, infection,
musculoskeletal pain, neutropenia, nausea, anemia,
thrombocytopenia, and diarrhea.
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).
INDICATIONS
BLINCYTO® (blinatumomab)
is indicated for the treatment of CD19-positive B-cell precursor
acute lymphoblastic leukemia (ALL) in adult and pediatric patients
one month and older with:
- Philadelphia chromosome-negative disease in the
consolidation phase of multiphase chemotherapy.
- Minimal residual disease (MRD) greater than or equal to 0.1% in
first or second complete remission.
- Relapsed or refractory disease.
Please
see BLINCYTO® full Prescribing
Information, including BOXED
WARNINGS.
About Bispecific T-Cell Engager
(BiTE®) Technology
BiTE technology
is a targeted immuno-oncology platform that is designed to engage a
patient's own T cells to any tumor-specific antigen, activating the
cytotoxic potential of T cells to eliminate detectable cancer. The
BiTE immuno-oncology platform has the potential to treat different
cancer types through tumor-specific antigens. The BiTE platform has
a goal of leading to off-the-shelf solutions, which have the
potential to make innovative T-cell treatment available to all
providers when their patients need it. For more than a
decade, Amgen has been advancing this innovative
technology, which has demonstrated strong efficacy in hematological
malignancies and now a solid tumor with the approval of
IMDELLTRA. Amgen remains committed to progressing
multiple BiTE molecules across a broad range of hematologic and
solid tumor malignancies, paving the way for additional
applications in more tumor types. Amgen is further
investigating BiTE technology with the goal of enhancing patient
experience and therapeutic potential. To learn more about BiTE
technology, visit BiTE® Technology 101.
About Amgen
Amgen discovers, develops, manufactures and delivers
innovative medicines to help millions of patients in their fight
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ago, Amgen helped to establish the biotechnology industry
and remains on the cutting-edge of innovation, using technology and
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References
- National Institute of Health. Cancer Stat Facts: Leukemia —
Acute Lymphocytic Leukemia (ALL). Available at:
https://seer.cancer.gov/statfacts/html/alyl.html. Accessed on
October 28, 2024.
- Terwilliger T, et al. Blood Cancer J.
2017;7(6):e577.
- American Cancer Society. What is Acute Lymphocytic
Leukemia (ALL)? Available at:
https://www.cancer.org/cancer/types/acute-lymphocytic-leukemia/about/what-is-all.html.
Accessed on October 28, 2024.
- Leukemia & Lymphoma Society. Acute Lymphoblastic
Leukemia (ALL). Available at:
https://www.lls.org/research/acute-lymphoblastic-leukemia-all.
Accessed on October 28, 2024.
- National Cancer Institute. Childhood Acute Lymphoblastic
Leukemia (PDQ®)–Patient Version. Available at:
https://www.cancer.gov/types/leukemia/patient/child-all-treatment-pdq.
Accessed on November 19, 2024.
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