Based on DESTINY-Breast04 results where
AstraZeneca and Daiichi Sankyo’s ENHERTU demonstrated a significant
improvement in both progression-free survival and overall
survival
ENHERTU has now been granted five
Breakthrough Therapy Designations, including three in breast cancer
and one in both lung and gastric cancers
AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab
deruxtecan-nxki) has been granted Breakthrough Therapy Designation
(BTD) in the US for the treatment of adult patients with
unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative)
breast cancer who have received a prior systemic therapy in the
metastatic setting or developed disease recurrence during or within
six months of completing adjuvant chemotherapy. Patients with
hormone receptor (HR) positive breast cancer should additionally
have received or be ineligible for endocrine therapy.
ENHERTU is a specifically engineered HER2-directed antibody drug
conjugate (ADC) being jointly developed and commercialized by
AstraZeneca and Daiichi Sankyo.
The Food and Drug Administration’s (FDA) BTD is designed to
accelerate the development and regulatory review of potential new
medicines that are intended to treat a serious condition and
address a significant unmet medical need. The new medicine needs to
have shown encouraging preliminary clinical results that
demonstrate substantial improvement on a clinically significant
endpoint over available medicines.
Up to half of all patients with breast cancer have tumors with a
HER2 immunohistochemistry (IHC) score of 1+, or 2+ in combination
with a negative in-situ hybridization (ISH) test, a level of HER2
expression not currently eligible for HER2-targeted therapy.1-4 Low
HER2 expression occurs in both HR-positive and HR-negative
disease.5
HER2 testing is routinely used to determine appropriate
treatment options for patients with metastatic breast cancer.
Targeting the lower range of expression in the HER2 spectrum may
offer another approach to delay disease progression and extend
survival in patients with metastatic breast cancer.6 Currently,
chemotherapy remains the only treatment option for patients with
HR-positive tumors following progression on endocrine (hormone)
therapy.7 Few targeted options are available for those who are
HR-negative.8
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca said: “Today’s news is a significant validation of the
potential we see for the historic DESTINY-Breast04 trial to enable
a paradigm shift in how breast cancer is classified by targeting
the full spectrum of HER2 expression. ENHERTU continues to show
transformative potential, and this milestone represents an
important advance for patients with HER2-low metastatic breast
cancer who are in urgent need of new treatment options and better
outcomes.”
Ken Takeshita, Global Head, R&D, Daiichi Sankyo said:
“Historically, only patients with HER2-positive metastatic breast
cancer were shown to benefit from HER2-directed therapy.
DESTINY-Breast04, in which ENHERTU showed a clinically meaningful
survival benefit in patients with HER2-low metastatic breast
cancer, is the first trial to demonstrate that selecting patients
for treatment based on low expression of HER2 has the potential to
change the diagnostic and treatment paradigms for these patients.
This Breakthrough Therapy Designation acknowledges the potential of
ENHERTU to fulfill an unmet medical need and we look forward to
working closely with the FDA to bring the first HER2-directed
therapy to patients with metastatic breast cancer whose tumors have
lower levels of HER2 expression.”
The FDA granted the BTD based on data from the pivotal
DESTINY-Breast04 Phase III trial which reported positive high-level
results in February 2022. In the trial, ENHERTU demonstrated a
statistically significant and clinically meaningful improvement in
both progression-free survival (PFS) and overall survival (OS) in
patients with HER2-low unresectable and/or metastatic breast cancer
in all randomized patients with HR-positive and HR-negative disease
versus physician’s choice of chemotherapy, which is the current
standard of care. The safety profile of ENHERTU was consistent with
previous clinical trials with no new safety concerns identified.
The data will be presented at an upcoming medical meeting.
This is the third BTD for ENHERTU in breast cancer. ENHERTU
previously received BTD’s for the treatment of second-line
HER2-positive metastatic breast cancer in 2021 and later-line
HER2-positive metastatic breast cancer in 2017. Two additional
BTD’s for ENHERTU were granted in 2020 for HER2-mutant metastatic
non-small cell lung cancer (NSCLC) and HER2-positive metastatic
gastric cancer.
Important Safety Information
Indications
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor
conjugate indicated for the treatment of adult patients with:
- Unresectable or metastatic HER2-positive breast cancer who have
received two or more prior anti-HER2-based regimens in the
metastatic setting. This indication is approved under accelerated
approval based on tumor response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial.
- Locally advanced or metastatic HER2-positive gastric or
gastroesophageal junction adenocarcinoma who have received a prior
trastuzumab-based regimen.
WARNING: INTERSTITIAL LUNG DISEASE and
EMBRYO-FETAL TOXICITY
- Interstitial lung disease (ILD) and pneumonitis, including
fatal cases, have been reported with ENHERTU. Monitor for and
promptly investigate signs and symptoms including cough, dyspnea,
fever, and other new or worsening respiratory symptoms. Permanently
discontinue ENHERTU in all patients with Grade 2 or higher
ILD/pneumonitis. Advise patients of the risk and to immediately
report symptoms.
- Exposure to ENHERTU during pregnancy can cause embryo-fetal
harm. Advise patients of these risks and the need for effective
contraception.
Contraindications
None.
Warnings and Precautions
Severe, life-threatening, or fatal interstitial lung disease
(ILD), including pneumonitis, can occur in patients treated with
ENHERTU. Advise patients to immediately report cough, dyspnea,
fever, and/or any new or worsening respiratory symptoms. Monitor
patients for signs and symptoms of ILD. Promptly investigate
evidence of ILD. Evaluate patients with suspected ILD by
radiographic imaging. Consider consultation with a pulmonologist.
For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until
resolved to Grade 0, then if resolved in ≤28 days from date of
onset, maintain dose. If resolved in >28 days from date of
onset, reduce dose one level. Consider corticosteroid treatment as
soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day
prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade
2 or greater), permanently discontinue ENHERTU. Promptly initiate
systemic corticosteroid treatment as soon as ILD/pneumonitis is
suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and
continue for at least 14 days followed by gradual taper for at
least 4 weeks.
Metastatic Breast Cancer
In clinical studies, of the 234 patients with unresectable or
metastatic HER2-positive breast cancer treated with ENHERTU 5.4
mg/kg, ILD occurred in 9% of patients. Fatal outcomes due to ILD
and/or pneumonitis occurred in 2.6% of patients treated with
ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to
8.3).
Locally Advanced or Metastatic Gastric
Cancer
In DESTINY-Gastric01, of the 125 patients with locally advanced
or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated
with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median
time to first onset was 2.8 months (range: 1.2 to 21.0).
Neutropenia
Severe neutropenia, including febrile neutropenia, can occur in
patients treated with ENHERTU. Monitor complete blood counts prior
to initiation of ENHERTU and prior to each dose, and as clinically
indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC]
<1.0 to 0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2
or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x
109/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce
dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and
temperature >38.3ºC or a sustained temperature of ≥38ºC for more
than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one
level.
Metastatic Breast Cancer
In clinical studies, of the 234 patients with unresectable or
metastatic HER2-positive breast cancer who received ENHERTU
5.4mg/kg, a decrease in neutrophil count was reported in 62% of
patients. Sixteen percent had Grade 3 or 4 decrease in neutrophil
count. Median time to first onset of decreased neutrophil count was
23 days (range: 6 to 547). Febrile neutropenia was reported in 1.7%
of patients.
Locally Advanced or Metastatic Gastric
Cancer
In DESTINY-Gastric01, of the 125 patients with locally advanced
or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated
with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported
in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased
neutrophil count. Median time to first onset of decreased
neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia
was reported in 4.8% of patients.
Left Ventricular Dysfunction
Patients treated with ENHERTU may be at increased risk of
developing left ventricular dysfunction. Left ventricular ejection
fraction (LVEF) decrease has been observed with anti-HER2
therapies, including ENHERTU. In the 234 patients with unresectable
or metastatic HER2-positive breast cancer who received ENHERTU, two
cases (0.9%) of asymptomatic LVEF decrease were reported. In
DESTINY-Gastric01, of the 125 patients with locally advanced or
metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with
ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were
reported; however, on echocardiography, 8% were found to have
asymptomatic Grade 2 decrease in LVEF. Treatment with ENHERTU has
not been studied in patients with a history of clinically
significant cardiac disease or LVEF <50% prior to initiation of
treatment.
Assess LVEF prior to initiation of ENHERTU and at regular
intervals during treatment as clinically indicated. When LVEF is
>45% and absolute decrease from baseline is 10-20%, continue
treatment with ENHERTU. When LVEF is 40-45% and absolute decrease
from baseline is <10%, continue treatment with ENHERTU and
repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and
absolute decrease from baseline is 10-20%, interrupt ENHERTU and
repeat LVEF assessment within 3 weeks. If LVEF has not recovered to
within 10% from baseline, permanently discontinue ENHERTU. If LVEF
recovers to within 10% from baseline, resume treatment with ENHERTU
at the same dose. When LVEF is <40% or absolute decrease from
baseline is >20%, interrupt ENHERTU and repeat LVEF assessment
within 3 weeks. If LVEF of <40% or absolute decrease from
baseline of >20% is confirmed, permanently discontinue ENHERTU.
Permanently discontinue ENHERTU in patients with symptomatic
congestive heart failure.
Embryo-Fetal Toxicity
ENHERTU can cause fetal harm when administered to a pregnant
woman. Advise patients of the potential risks to a fetus. Verify
the pregnancy status of females of reproductive potential prior to
the initiation of ENHERTU. Advise females of reproductive potential
to use effective contraception during treatment and for at least 7
months following the last dose of ENHERTU. Advise male patients
with female partners of reproductive potential to use effective
contraception during treatment with ENHERTU and for at least 4
months after the last dose of ENHERTU.
Additional Dose Modifications
Thrombocytopenia
For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L)
interrupt ENHERTU until resolved to Grade 1 or less, then maintain
dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L)
interrupt ENHERTU until resolved to Grade 1 or less. Reduce dose by
one level.
Adverse Reactions
Metastatic Breast Cancer
The safety of ENHERTU was evaluated in a pooled analysis of 234
patients with unresectable or metastatic HER2-positive breast
cancer who received at least one dose of ENHERTU 5.4 mg/kg in
DESTINY-Breast01 and Study DS8201-A-J101. ENHERTU was administered
by intravenous infusion once every three weeks. The median duration
of treatment was 7 months (range: 0.7 to 31).
Serious adverse reactions occurred in 20% of patients receiving
ENHERTU. Serious adverse reactions in >1% of patients who
received ENHERTU were interstitial lung disease, pneumonia,
vomiting, nausea, cellulitis, hypokalemia, and intestinal
obstruction. Fatalities due to adverse reactions occurred in 4.3%
of patients including interstitial lung disease (2.6%), and the
following events occurred in one patient each (0.4%): acute hepatic
failure/acute kidney injury, general physical health deterioration,
pneumonia, and hemorrhagic shock.
ENHERTU was permanently discontinued in 9% of patients, of which
ILD accounted for 6%. Dose interruptions due to adverse reactions
occurred in 33% of patients treated with ENHERTU. The most frequent
adverse reactions (>2%) associated with dose interruption were
neutropenia, anemia, thrombocytopenia, leukopenia, upper
respiratory tract infection, fatigue, nausea, and ILD. Dose
reductions occurred in 18% of patients treated with ENHERTU. The
most frequent adverse reactions (>2%) associated with dose
reduction were fatigue, nausea, and neutropenia.
The most common (≥20%) adverse reactions, including laboratory
abnormalities, were nausea (79%), white blood cell count decreased
(70%), hemoglobin decreased (70%), neutrophil count decreased
(62%), fatigue (59%), vomiting (47%), alopecia (46%), aspartate
aminotransferase increased (41%), alanine aminotransferase
increased (38%), platelet count decreased (37%), constipation
(35%), decreased appetite (32%), anemia (31%), diarrhea (29%),
hypokalemia (26%), and cough (20%).
Locally Advanced or Metastatic Gastric
Cancer
The safety of ENHERTU was evaluated in 187 patients with locally
advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma
in DESTINY‑Gastric01. Patients intravenously received at least one
dose of either ENHERTU (N=125) 6.4 mg/kg once every three weeks or
either irinotecan (N=55) 150 mg/m2 biweekly or paclitaxel (N=7) 80
mg/m2 weekly for 3 weeks. The median duration of treatment was 4.6
months (range: 0.7 to 22.3) in the ENHERTU group and 2.8 months
(range: 0.5 to 13.1) in the irinotecan/paclitaxel group.
Serious adverse reactions occurred in 44% of patients receiving
ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients
who received ENHERTU were decreased appetite, ILD, anemia,
dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor
hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of
patients: disseminated intravascular coagulation, large intestine
perforation, and pneumonia occurred in one patient each (0.8%).
ENHERTU was permanently discontinued in 15% of patients, of
which ILD accounted for 6%. Dose interruptions due to adverse
reactions occurred in 62% of patients treated with ENHERTU. The
most frequent adverse reactions (>2%) associated with dose
interruption were neutropenia, anemia, decreased appetite,
leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia,
upper respiratory tract infection, diarrhea, and hypokalemia. Dose
reductions occurred in 32% of patients treated with ENHERTU. The
most frequent adverse reactions (>2%) associated with dose
reduction were neutropenia, decreased appetite, fatigue, nausea,
and febrile neutropenia.
The most common (≥20%) adverse reactions, including laboratory
abnormalities, were hemoglobin decreased (75%), white blood cell
count decreased (74%), neutrophil count decreased (72%), lymphocyte
count decreased (70%), platelet count decreased (68%), nausea
(63%), decreased appetite (60%), anemia (58%), aspartate
aminotransferase increased (58%), fatigue (55%), blood alkaline
phosphatase increased (54%), alanine aminotransferase increased
(47%), diarrhea (32%), hypokalemia (30%), vomiting (26%),
constipation (24%), blood bilirubin increased (24%), pyrexia (24%),
and alopecia (22%).
Use in Specific Populations
- Pregnancy: ENHERTU can cause fetal harm when
administered to a pregnant woman. Advise patients of the potential
risks to a fetus. There are clinical considerations if ENHERTU is
used in pregnant women, or if a patient becomes pregnant within 7
months following the last dose of ENHERTU.
- Lactation: There are no data regarding the presence of
ENHERTU in human milk, the effects on the breastfed child, or the
effects on milk production. Because of the potential for serious
adverse reactions in a breastfed child, advise women not to
breastfeed during treatment with ENHERTU and for 7 months after the
last dose.
- Females and Males of Reproductive Potential:
Pregnancy testing: Verify pregnancy
status of females of reproductive potential prior to initiation of
ENHERTU. Contraception: Females:
ENHERTU can cause fetal harm when administered to a pregnant woman.
Advise females of reproductive potential to use effective
contraception during treatment with ENHERTU and for at least 7
months following the last dose. Males: Advise male patients with
female partners of reproductive potential to use effective
contraception during treatment with ENHERTU and for at least 4
months following the last dose. Infertility: ENHERTU may impair male reproductive
function and fertility.
- Pediatric Use: Safety and effectiveness of ENHERTU have
not been established in pediatric patients.
- Geriatric Use: Of the 234 patients with HER2-positive
breast cancer treated with ENHERTU 5.4 mg/kg, 26% were ≥65 years
and 5% were ≥75 years. No overall differences in efficacy were
observed between patients ≥65 years of age compared to younger
patients. There was a higher incidence of Grade 3-4 adverse
reactions observed in patients aged ≥65 years (53%) as compared to
younger patients (42%). Of the 125 patients with locally advanced
or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated
with ENHERTU 6.4 mg/kg in DESTINY-Gastric01, 56% were ≥65 years and
14% were ≥75 years. No overall differences in efficacy or safety
were observed between patients ≥65 years of age compared to younger
patients.
- Hepatic Impairment: In patients with moderate hepatic
impairment, due to potentially increased exposure, closely monitor
for increased toxicities related to the topoisomerase
inhibitor.
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi
Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or
fda.gov/medwatch.
Please see accompanying full Prescribing Information,
including Boxed WARNINGS, and Medication Guide.
Notes
Breast cancer and HER2 expression
Breast cancer is the most common cancer and is one of the
leading causes of cancer-related deaths worldwide and in the
US.9,10 More than two million cases of breast cancer were diagnosed
in 2020 resulting in nearly 685,000 deaths globally.9 In the US,
more than 290,000 new cases are expected to be diagnosed in 2022,
resulting in more than 43,000 deaths.11
HER2 is a tyrosine kinase receptor growth-promoting protein
expressed on the surface of many types of tumors including breast,
gastric, lung and colorectal cancers, and is one of many biomarkers
expressed in breast cancer tumors.12 HER2 expression is currently
defined as either positive or negative, and is determined by an IHC
test which measures the amount of HER2 protein on a cancer cell,
and/or an ISH test which counts the copies of the HER2 gene in
cancer cells.12,13 HER2-positive cancers are defined as IHC 3+ or
IHC 2+/ISH+, and HER2-negative cancers are currently defined as IHC
0, IHC 1+ or IHC 2+/ISH-.12
DESTINY-Breast04
DESTINY-Breast04 is a global, randomized, open-label,
registrational Phase III trial evaluating the efficacy and safety
of ENHERTU (5.4 mg/kg) versus physician’s choice of chemotherapy
(capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel)
in patients with HR-positive (n=480) or HR-negative (n=60) HER2-low
unresectable and/or metastatic breast cancer previously treated
with one or two prior lines of chemotherapy. Patients were
randomized 2:1 to receive either ENHERTU or chemotherapy.
The primary endpoint of DESTINY-Breast04 is PFS in patients with
HR-positive disease based on blinded independent central review
(BICR). Key secondary endpoints include PFS based on BICR in all
randomized patients (HR-positive and HR-negative disease), OS in
patients with HR-positive disease and OS in all randomized patients
(HR-positive and HR-negative disease). Other secondary endpoints
include PFS based on BICR and investigator assessment, duration of
response based on BICR and safety.
DESTINY-Breast04 enrolled approximately 540 patients at multiple
sites in Asia, Europe and North America. For more information about
the trial, visit ClinicalTrials.gov.
ENHERTU
ENHERTU is a HER2-directed ADC. Designed using Daiichi Sankyo’s
proprietary DXd ADC technology, ENHERTU is the lead ADC in the
oncology portfolio of Daiichi Sankyo and the most advanced program
in AstraZeneca’s ADC scientific platform. ENHERTU consists of a
HER2 monoclonal antibody attached to a topoisomerase I inhibitor
payload, an exatecan derivative, via a stable tetrapeptide-based
cleavable linker.
ENHERTU (5.4 mg/kg) is approved in more than 40 countries for
the treatment of adult patients with unresectable or metastatic
HER2-positive breast cancer who have received two or more prior
anti-HER2-based regimens based on the results from the
DESTINY-Breast01 trial.
ENHERTU (6.4mg/kg) is approved in several countries for the
treatment of adult patients with locally advanced or metastatic
HER2-positive gastric or gastroesophageal junction (GEJ)
adenocarcinoma who have received a prior trastuzumab-based regimen
based on the results from the DESTINY-Gastric01 trial.
ENHERTU development program
A comprehensive development program is underway globally,
evaluating the efficacy and safety of ENHERTU monotherapy across
multiple HER2-targetable cancers, including breast, gastric, lung
and colorectal cancers. Trials in combination with other anticancer
treatments, such as immunotherapy, are also underway.
Regulatory applications for ENHERTU are currently under review
in Europe, Japan, the US and several other countries for the
treatment of adult patients with unresectable or metastatic
HER2-positive breast cancer who have received a prior
anti-HER2-based regimen based on the results from the
DESTINY-Breast03 trial.
ENHERTU is also currently under review in the US for the
treatment of adult patients with unresectable or metastatic
non-small cell lung cancer (NSCLC) whose tumors have a HER2 (ERBB2)
mutation and who have received a prior systemic therapy, and in
Europe for the treatment of adult patients with locally advanced or
metastatic HER2-positive gastric or GEJ adenocarcinoma who have
received a prior anti-HER2 based regimen based on the
DESTINY-Gastric01 and DESTINY-Gastric02 trials.
Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as
Daiichi Sankyo] and AstraZeneca entered into a global collaboration
to jointly develop and commercialize ENHERTU (a HER2-directed ADC)
in March 2019, and datopotamab deruxtecan (DS-1062; a
TROP2-directed ADC) in July 2020, except in Japan where Daiichi
Sankyo maintains exclusive rights. Daiichi Sankyo is responsible
for manufacturing and supply of ENHERTU and datopotamab
deruxtecan.
AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology,
AstraZeneca is starting to challenge, and redefine, the current
clinical paradigm for how breast cancer is classified and treated
to deliver even more effective treatments to patients in need –
with the bold ambition to one day eliminate breast cancer as a
cause of death.
AstraZeneca has a comprehensive portfolio of approved and
promising compounds in development that leverage different
mechanisms of action to address the biologically diverse breast
cancer tumor environment.
AstraZeneca aims to continue to transform outcomes for
HR-positive breast cancer with foundational medicines fulvestrant
and goserelin and the next-generation oral selective estrogen
receptor degrader (SERD) and potential new medicine
camizestrant.
PARP inhibitor olaparib is a targeted treatment option that has
been studied in HER2-negative early and metastatic breast cancer
patients with an inherited BRCA mutation. AstraZeneca with MSD
(Merck & Co., Inc. in the US and Canada) continue to research
olaparib in metastatic breast cancer patients with an inherited
BRCA mutation and are exploring new opportunities to treat these
patients earlier in their disease.
Building on the first approval of ENHERTU, a HER2-directed ADC,
in previously treated HER2-positive metastatic breast cancer,
AstraZeneca and Daiichi Sankyo are exploring its potential in
earlier lines of treatment and in new breast cancer settings.
To bring much-needed treatment options to patients with
triple-negative breast cancer, an aggressive form of breast cancer,
AstraZeneca is testing immunotherapy durvalumab in combination with
other oncology medicines, including olaparib and ENHERTU,
evaluating the potential of AKT kinase inhibitor, capivasertib, in
combination with chemotherapy, and collaborating with Daiichi
Sankyo to explore the potential of TROP2-directed ADC, datopotamab
deruxtecan.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the
ambition to provide cures for cancer in every form, following the
science to understand cancer and all its complexities to discover,
develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyze changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines in Oncology, Rare Diseases and
BioPharmaceuticals, including Cardiovascular, Renal &
Metabolism, and Respiratory & Immunology. Based in Cambridge,
UK, AstraZeneca operates in over 100 countries, and its innovative
medicines are used by millions of patients worldwide. For more
information, please visit www.astrazeneca-us.com and follow us on
Twitter @AstraZenecaUS.
References
1. Ahn S, et al. HER2 status in breast cancer: changes in
guidelines and complicating factors for interpretation. J Pathol
Transl Med. 2020; 54(1): 34-44.
2. Schalper K, et al. A retrospective population-based
comparison of HER2 immunohistochemistry and fluorescence in situ
hybridization in breast carcinomas. Arch Pathol Lab Med. 2014;
138:213-219.
3. Schettini F, et al. Clinical, pathological, and PAM50 gene
expression features of HER2-low breast cancer. npj Breast Cancer.
2021; 7:1 ; https://doi.org/10.1038/s41523-020-00208-2
4. Denkert C, et al. Clinical and molecular characteristics of
HER2-low-positive breast cancer: pooled analysis of individual
patient data from four prospective, neoadjuvant clinical trials.
2021. Lancet Oncol; 22: 1151–61.
5. Miglietta F, et al. Evolution of HER2-low expression from
primary to recurrent breast cancer. NPJ Breast Cancer. 2021; 7:137;
10.1038/s41523-021-00343-4.
6. Eiger D, et al. The Exciting New Field of HER2-Low Breast
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Status. Available at:
https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-hormone-receptor-status.html.
Accessed April 2022.
9. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN
Estimates of Incidence and Mortality Worldwide for 36 Cancers in
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Available at: https://gis.cdc.gov/Cancer/USCS/#/AtAGlance/. Last
accessed: April 2022.
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https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html.
Last accessed: April 2022.
12. Iqbal N, et al. Human Epidermal Growth Factor Receptor 2
(HER2) in Cancers: Overexpression and Therapeutic Implications. Mol
Biol Int. 2014;852748.
13. Wolff A, et al. Human Epidermal Growth Factor Receptor 2
Testing in Breast Cancer: American Society of Clinical
Oncology/College of American Pathologists Clinical Practice
Guideline Focused Update. Arch Pathol Lab Med. 2018; 142 (11):
1364-1382.
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