First HER2-low metastatic breast cancer
Phase III results for AstraZeneca and Daiichi Sankyo’s ENHERTU
offer potential to redefine how the disease is classified and
treated
Positive high-level results from the pivotal DESTINY-Breast04
Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki)
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 regardless of hormone receptor (HR) status
versus physician’s choice of chemotherapy.
ENHERTU is a HER2-directed antibody drug conjugate (ADC) being
jointly developed by AstraZeneca and Daiichi Sankyo.
All patients in the trial received a HER2 test, and the results
were centrally confirmed. HER2-low status was defined as an
immunohistochemistry (IHC) score of 1+ or IHC 2+ with a negative
in-situ hybridization (ISH) score.
Up to 55% of all patients with breast cancer have tumors with an
HER2 IHC score of 1+, or 2+ in combination with a negative ISH
test, a level of HER2 expression not currently eligible for
HER2-targeted therapy.1,2 HER2-low expression occurs in both
HR-positive and HR-negative disease.3
HER2 testing is well established to determine an appropriate
treatment strategy in metastatic breast cancer. Targeting the lower
range of HER2 expression may offer another approach to delay
disease progression and extend survival in patients with metastatic
breast cancer.4 Currently, chemotherapy remains the only treatment
option both for patients with HR-positive tumors following
progression on endocrine (hormone) therapy, and for those who are
HR-negative.5
DESTINY-Breast04 met its primary endpoint, where ENHERTU
demonstrated superior PFS in previously treated patients with
HR-positive HER2-low metastatic breast cancer compared to the
standard-of-care chemotherapy. The trial met the key secondary
endpoint of PFS in patients with HER2-low metastatic breast cancer
regardless of HR status (HR-positive or HR-negative). The trial
also met the key secondary endpoints of OS in patients with
HR-positive disease and in patients regardless of HR status at
interim analysis.
The safety profile of ENHERTU was consistent with previous
clinical trials, with no new safety concerns identified. Overall
interstitial lung disease (ILD) rates were consistent with that
observed in late-line HER2-positive breast cancer trials of
ENHERTU, with a lower rate of Grade 5 ILD observed as determined by
an independent adjudication committee.
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca said: “Today’s historic news from DESTINY-Breast04
could reshape how breast cancer is classified and treated. A
HER2-directed therapy has never-before shown a benefit in patients
with HER2-low metastatic breast cancer. These results for ENHERTU
are a huge step forward and could potentially expand our ability to
target the full spectrum of HER2 expression, validating the need to
change the way we categorize and treat breast cancer.”
Ken Takeshita, Global Head, R&D, Daiichi Sankyo said:
“ENHERTU continues to redefine the treatment of HER2-targetable
cancers. DESTINY-Breast04 is the first ever Phase III trial of a
HER2-directed therapy in patients with HER2-low metastatic breast
cancer to show statistically significant and clinically meaningful
benefit in progression-free and overall survival compared to
standard treatment. We look forward to sharing the detailed
findings of DESTINY-Breast04 with the medical community and
initiating discussions with regulatory agencies globally with the
goal of bringing ENHERTU to patients with metastatic breast cancer
previously considered to be HER2-negative.”
The data will be presented at a forthcoming medical meeting and
shared with global health authorities.
ENHERTU (5.4mg/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 is being further assessed in a comprehensive clinical
development program evaluating efficacy and safety across multiple
HER2-targetable cancers, including breast, gastric, lung and
colorectal cancers.
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.6 More than two
million cases of breast cancer were diagnosed in 2020 resulting in
nearly 685,000 deaths globally.6 Additionally, breast cancer is the
most commonly diagnosed cancer among Americans, with over 290,000
new cases expected in the U.S. in 2022.7
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.8 HER2 expression is currently
defined as either positive or negative, and is determined by an IHC
test which measures the amount of HER2 protein in a cancer cell,
and/or an ISH test which counts the copies of the HER2 gene in
cancer cells.8,9 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-.8
DESTINY-Breast04
DESTINY-Breast04 is a global, randomized, open-label, pivotal
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 (regardless of HR status), OS in patients with
HR-positive disease and OS in all randomized patients (regardless
of HR status). 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 (5.4mg/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 also is currently under review 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 (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
FASLODEX and ZOLADEX and the next-generation oral selective
estrogen receptor degrader (SERD) and potential new medicine
camizestrant.
PARP inhibitor LYNPARZA is a targeted treatment option for
metastatic breast cancer patients with an inherited BRCA mutation.
LYNPARZA has also demonstrated a statistically significant and
clinically meaningful improvement in invasive disease-free survival
versus placebo in the adjuvant treatment of patients with germline
BRCA-mutated HER2-negative early breast cancer. AstraZeneca with
MSD (Merck & Co., Inc. in the US and Canada) continue to
research LYNPARZA 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 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 IMFINZI in combination with
other oncology medicines, including LYNPARZA 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
- Tarantino P, et al. HER2-Low Breast Cancer: Pathological and
Clinical Landscape. J Clin Oncol. 2020;38(17):1951-1962.
- Ahn S, et al. HER2 status in breast cancer: changes in
guidelines and complicating factors forinterpretation. J Pathol
Transl Med. 2020; 54(1): 34–44.
- 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.
- Eiger D, et al. The Exciting New Field of HER2-Low Breast
Cancer Treatment. Cancers. 2021; 10.3390/cancers13051015.
- Matutino A, et al. Hormone receptor–positive, HER2-negative
metastatic breast cancer: redrawing the lines. Current Oncology.
2018; 25(S1):S131-S141
- Sung H, et al. Global cancer statistics 2020: GLOBOCAN
estimates of incidence and mortality worldwide for 36 cancers in
185 countries. CA Cancer J Clin. 2021; 10.3322/caac.21660.
- American Cancer Society. Cancer Facts & Figures 2022.
Available at:
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf.
Accessed January 2022.
- Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2)
in Cancers: Overexpression and Therapeutic Implications. Mol Biol
Int. 2014;852748.
- 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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