BLINCYTO Added to Multiphase
Consolidation Chemotherapy Significantly Reduced the Risk of Death
Versus Chemotherapy Alone
THOUSAND
OAKS, Calif., Jan. 29,
2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced that the European Commission (EC) has approved
BLINCYTO® (blinatumomab) monotherapy as part of
consolidation therapy for the treatment of adult patients with
newly diagnosed Philadelphia
chromosome-negative CD19-positive B-cell precursor acute
lymphoblastic leukemia (B-ALL).
"This approval represents a significant advancement, offering
patients the opportunity to receive BLINCYTO earlier in their
treatment pathway, with the potential to improve outcomes," said
Jean-Charles Soria, senior vice
president of Global Oncology Development at Amgen. "The E1910
data that served as the basis of this approval adds to the growing
body of evidence of the meaningful survival impact of
BLINCYTO."
The Phase 3 E1910 clinical trial led by ECOG-ACRIN Cancer
Research Group studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL
receiving postinduction consolidation treatment, which aims to
deepen remission to achieve durable responses. Study
results demonstrated that BLINCYTO added to multiphase
consolidation chemotherapy showed superior overall
survival (OS) versus chemotherapy alone. With a median
follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO
plus chemotherapy arm (n=112) and 62.5% in the chemotherapy arm
(n=112).
"While there has been some treatment progress, many patients
with newly diagnosed Philadelphia
chromosome-negative B-ALL remain at high risk of relapse," said
Robin Foà, M.D., emeritus professor of hematology, Sapienza
University of Rome. "The E1910
study results highlight that BLINCYTO has the potential to advance
frontline consolidation treatment, including patients who are
minimal residual disease (MRD)-negative, offering a crucial new
option to achieve deeper remissions and improve long-term
survival."
The E1910 study was designed and conducted independently from
industry. ECOG-ACRIN led the trial with public funding and
sponsorship provided by the National Cancer Institute (NCI), part
of the National Institutes of Health (NIH). Other NCI-funded
network groups took part in the study. 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. In Europe, ALL has an estimated prevalence of
1.28 persons per 100,000 people.1 Among both children
and adults, the most common subtype of ALL is
B-ALL.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.4
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.
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 month 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 month or older with high-risk first
relapsed Philadelphia
chromosome-negative CD19-positive B-ALL as part of the
consolidation therapy.
- Adult patients with newly diagnosed Philadelphia chromosome-negative CD19-positive
B-ALL as part of consolidation therapy.
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.
EU SAFETY INFORMATION FOR BLINCYTO®
The
safety profile of BLINCYTO in the Phase 3 E1910 study was
consistent with the known safety profile for BLINCYTO.
See BLINCYTO® full Summary of Product
Characteristics (SmPC) at www.ema.europa.eu
About BiTE® Technology
Bispecific T-cell
Engager (BiTE®) technology is a targeted immuno-oncology
platform that is designed to engage 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 tumor
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. Amgen is advancing
multiple BiTE® molecules across a broad range of
hematologic malignancies and solid tumors, further investigating
BiTE® technology with the goal of enhancing patient
experience and therapeutic potential. To learn more about
BiTE® technology, visit
https://www.amgenoncology.com/bite-platform.html.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative
medicines to help millions of patients in their fight against some
of the world's toughest diseases. More than 40 years ago, Amgen
helped to establish the biotechnology industry and remains on the
cutting-edge of innovation, using technology and human genetic data
to push beyond what's known today. Amgen is advancing a broad and
deep pipeline that builds on its existing portfolio of medicines to
treat cancer, heart disease, osteoporosis, inflammatory diseases
and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative
Companies" by Fast Company and one of "America's Best Large
Employers" by Forbes, among other external recognitions. Amgen
is one of the 30 companies that comprise the Dow Jones Industrial
Average®, and it is also part of the Nasdaq-100
Index®, which includes the largest and most innovative
non-financial companies listed on the Nasdaq Stock Market based on
market capitalization.
For more information, visit Amgen.com and follow Amgen on X,
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CONTACT: Amgen, Thousand
Oaks
Elissa Snook, 609-251-1407
(media)
Justin Claeys, 805-313-9775
(investors)
- Hoelzer, D, Bassan R, Dombret H, et al. et al. Ann
Oncol. 2016;27(suppl 5):v69-v82.
- Terwilliger T, Abdul-Hay M..
Blood Cancer J. doi:10.1038/bcj.2017.53.
- 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 January 2, 2025.
- Leukemia & Lymphoma Society. Acute Lymphoblastic Leukemia
(ALL). Available at:
https://www.lls.org/research/acute-lymphoblastic-leukemia-all.
Accessed on January 2, 2025.
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