OlympiA Phase III trial of LYNPARZA in the
adjuvant treatment of BRCA-mutated high-risk HER2-negative early
breast cancer will be analyzed and reported early
AstraZeneca and Merck & Co., Inc., known as MSD outside the
US and Canada, today announced the OlympiA Phase III trial for
LYNPARZA® (olaparib) will move to early primary analysis and
reporting following a recommendation from the Independent Data
Monitoring Committee (IDMC).
Based on the planned interim analysis, the IDMC concluded that
the trial crossed the superiority boundary for its primary endpoint
of invasive disease-free survival (iDFS) and demonstrated a
sustainable, clinically relevant treatment effect for LYNPARZA
versus placebo for patients with germline BRCA-mutated (gBRCAm)
high-risk human epidermal growth factor receptor 2 (HER2)-negative
early breast cancer, and recommend primary analysis now take
place.
The OlympiA Phase III trial is a partnership between Breast
International Group (BIG), NRG Oncology, the US National Cancer
Institute (NCI), Frontier Science & Technology Research
Foundation (FSTRF), AstraZeneca and Merck.1 The trial is sponsored
by NRG Oncology in the US and by AstraZeneca outside the US.
An estimated 2.3 million women were diagnosed with breast cancer
worldwide in 2020, and BRCA mutations are found in approximately 5%
of breast cancer patients.2-10 Around 55-65% of women with a BRCA1
mutation and approximately 45% with a BRCA2 mutation will develop
breast cancer before the age of 70.11
Andrew Tutt, Global Chair of the OlympiA Phase III trial and
Professor, Institute of Cancer Research and Kings College London,
said: “We are delighted that our global academic and industry
partnership has been able to help investigate a possible
personalized treatment for women with hereditary breast cancer. The
most common cause of hereditary breast cancer is an inherited
mutation in the BRCA1 or BRCA2 genes which also may cause the
disease to develop at a significantly earlier age than is usual.
The OlympiA trial has allowed us to go beyond using genetic testing
to identify patients who are at risk of this disease and explore
the potential of LYNPARZA to prevent disease recurrence for these
patients. We look forward to analyzing and presenting the full
results of the trial at a forthcoming medical meeting.”
José Baselga, Executive Vice President, Oncology R&D, said:
“Breast cancer remains one of the most common cancers globally and
despite advances in treatment, many patients with high-risk disease
will unfortunately develop a recurrence. We look forward to
reviewing the results.”
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, Merck, said: “Analysis of the
OlympiA trial, based upon the IDMC recommendation, could represent
a potential step forward for patients with early-stage, high-risk
primary breast cancer with a germline BRCA mutation.”
In its communication, the IDMC did not raise any new safety
concerns. The trial will continue to assess the key secondary
endpoints of overall survival and distant disease-free
survival.
In the US, LYNPARZA is approved for the treatment of adult
patients with deleterious or suspected deleterious gBRCAm,
HER2-negative metastatic breast cancer who have been treated with
chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
Patients with hormone receptor (HR)-positive breast cancer should
have been treated with a prior endocrine therapy or be considered
inappropriate for endocrine therapy. Select patients for therapy
based on an FDA-approved companion diagnostic for LYNPARZA.
LYNPARZA is not currently approved for the adjuvant treatment of
gBRCAm high-risk HER2-negative early breast cancer.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
There are no contraindications for LYNPARZA.
WARNINGS AND PRECAUTIONS
Myelodysplastic Syndrome/Acute Myeloid Leukemia
(MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA
monotherapy, and the majority of events had a fatal outcome. The
duration of therapy in patients who developed secondary MDS/AML
varied from <6 months to >2 years. All of these patients had
previous chemotherapy with platinum agents and/or other
DNA-damaging agents, including radiotherapy, and some also had a
history of more than one primary malignancy or of bone marrow
dysplasia.
Do not start LYNPARZA until patients have recovered from
hematological toxicity caused by previous chemotherapy (≤Grade 1).
Monitor complete blood count for cytopenia at baseline and monthly
thereafter for clinically significant changes during treatment. For
prolonged hematological toxicities, interrupt LYNPARZA and monitor
blood count weekly until recovery.
If the levels have not recovered to Grade 1 or less after 4
weeks, refer the patient to a hematologist for further
investigations, including bone marrow analysis and blood sample for
cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.
Pneumonitis: Occurred in <1% of patients exposed to
LYNPARZA, and some cases were fatal. If patients present with new
or worsening respiratory symptoms such as dyspnea, cough, and
fever, or a radiological abnormality occurs, interrupt LYNPARZA
treatment and initiate prompt investigation. Discontinue LYNPARZA
if pneumonitis is confirmed and treat patient appropriately.
Embryo-Fetal Toxicity: Based on its mechanism of action
and findings in animals, LYNPARZA can cause fetal harm. A pregnancy
test is recommended for females of reproductive potential prior to
initiating treatment.
Females Advise females of reproductive potential of the
potential risk to a fetus and to use effective contraception during
treatment and for 6 months following the last dose.
Males Advise male patients with female partners of reproductive
potential or who are pregnant to use effective contraception during
treatment and for 3 months following the last dose of LYNPARZA and
to not donate sperm during this time.
Venous Thromboembolic Events: Including pulmonary
embolism, occurred in 7% of patients with metastatic
castration-resistant prostate cancer who received LYNPARZA plus
androgen deprivation therapy (ADT) compared to 3.1% of patients
receiving enzalutamide or abiraterone plus ADT in the PROfound
study. Patients receiving LYNPARZA and ADT had a 6% incidence of
pulmonary embolism compared to 0.8% of patients treated with ADT
plus either enzalutamide or abiraterone. Monitor patients for signs
and symptoms of venous thrombosis and pulmonary embolism, and treat
as medically appropriate, which may include long-term
anticoagulation as clinically indicated.
ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced
Ovarian Cancer
Most common adverse reactions (Grades 1-4) in ≥10% of patients
in clinical trials of LYNPARZA in the first-line maintenance
setting for SOLO-1 were: nausea (77%), fatigue (67%),
abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%),
constipation (28%), upper respiratory tract
infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia
(26%), decreased appetite (20%), dizziness (20%), neutropenia
(17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), UTI (13%),
thrombocytopenia (11%), and stomatitis (11%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients in clinical trials of LYNPARZA in the first-line
maintenance setting for SOLO-1 were: decrease in
hemoglobin (87%), increase in mean corpuscular volume (87%),
decrease in leukocytes (70%), decrease in lymphocytes (67%),
decrease in absolute neutrophil count (51%), decrease in platelets
(35%), and increase in serum creatinine (34%).
ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian
Cancer in Combination with Bevacizumab
Most common adverse reactions (Grades 1-4) in ≥10% of patients
treated with LYNPARZA/bevacizumab compared to a ≥5% frequency for
placebo/bevacizumab in the first-line maintenance setting
for PAOLA-1 were: nausea (53%), fatigue (including asthenia)
(53%), anemia (41%), lymphopenia (24%), vomiting (22%) and
leukopenia (18%). In addition, the most common adverse reactions
(≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of
the frequency compared with the placebo/bevacizumab arm were:
diarrhea (18%), neutropenia (18%), urinary tract infection (15%)
and headache (14%).
In addition, venous thromboembolic events occurred more commonly
in patients receiving LYNPARZA/bevacizumab (5%) than in those
receiving placebo/bevacizumab (1.9%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients for LYNPARZA in combination with bevacizumab in the
first-line maintenance setting for PAOLA-1 were:
decrease in hemoglobin (79%), decrease in lymphocytes (63%),
increase in serum creatinine (61%), decrease in leukocytes (59%),
decrease in absolute neutrophil count (35%) and decrease in
platelets (35%).
ADVERSE REACTIONS—Maintenance Recurrent Ovarian
Cancer
Most common adverse reactions (Grades 1-4) in ≥20% of patients
in clinical trials of LYNPARZA in the maintenance setting
for SOLO-2 were: nausea (76%), fatigue (including asthenia)
(66%), anemia (44%), vomiting (37%), nasopharyngitis/upper
respiratory tract infection (URI)/influenza (36%), diarrhea (33%),
arthralgia/myalgia (30%), dysgeusia (27%), headache (26%),
decreased appetite (22%), and stomatitis (20%).
Study 19: nausea (71%), fatigue (including asthenia)
(63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory
tract infection (22%), constipation (22%), headache (21%),
decreased appetite (21%) and dyspepsia (20%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients in clinical trials of LYNPARZA in the maintenance
setting (SOLO-2/Study 19) were: increase in mean corpuscular
volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in
leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease
in absolute neutrophil count (51%/47%), increase in serum
creatinine (44%/45%), and decrease in platelets (42%/36%).
ADVERSE REACTIONS—Advanced gBRCAm Ovarian Cancer
Most common adverse reactions (Grades 1-4) in ≥20% of patients
in clinical trials of LYNPARZA for advanced gBRCAm ovarian
cancer after 3 or more lines of chemotherapy (pooled from 6
studies) were: fatigue/asthenia (66%), nausea (64%), vomiting
(43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper
respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia
(22%), decreased appetite (22%), and arthralgia/musculoskeletal
pain (21%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients in clinical trials of LYNPARZA for advanced gBRCAm
ovarian cancer (pooled from 6 studies) were: decrease in
hemoglobin (90%), mean corpuscular volume elevation (57%), decrease
in lymphocytes (56%), increase in serum creatinine (30%), decrease
in platelets (30%), and decrease in absolute neutrophil count
(25%).
ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast
Cancer
Most common adverse reactions (Grades 1-4) in ≥20% of patients
in OlympiAD were: nausea (58%), anemia (40%), fatigue
(including asthenia) (37%), vomiting (30%), neutropenia (27%),
respiratory tract infection (27%), leukopenia (25%), diarrhea
(21%), and headache (20%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients in OlympiAD were: decrease in hemoglobin (82%),
decrease in lymphocytes (73%), decrease in leukocytes (71%),
increase in mean corpuscular volume (71%), decrease in absolute
neutrophil count (46%), and decrease in platelets (33%).
ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic
Pancreatic Adenocarcinoma
Most common adverse reactions (Grades 1-4) in ≥10% of patients
in clinical trials of LYNPARZA in the first-line maintenance
setting for POLO were: fatigue (60%), nausea (45%),
abdominal pain (34%), diarrhea (29%), anemia (27%), decreased
appetite (25%), constipation (23%), vomiting (20%), back pain
(19%), arthralgia (15%), rash (15%), thrombocytopenia (14%),
dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia
(11%), and stomatitis (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients in clinical trials of LYNPARZA in the first-line
maintenance setting for POLO were: increase in serum
creatinine (99%), decrease in hemoglobin (86%), increase in mean
corpuscular volume (71%), decrease in lymphocytes (61%), decrease
in platelets (56%), decrease in leukocytes (50%), and decrease in
absolute neutrophil count (25%).
ADVERSE REACTIONS—HRR Gene-mutated Metastatic
Castration-Resistant Prostate Cancer
Most common adverse reactions (Grades 1-4) in ≥10% of patients
in clinical trials of LYNPARZA for PROfound were: anemia
(46%), fatigue (including asthenia) (41%), nausea (41%), decreased
appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia
(12%), cough (11%), and dyspnea (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients in clinical trials of LYNPARZA for PROfound were:
decrease in hemoglobin (98%), decrease in lymphocytes (62%),
decrease in leukocytes (53%), and decrease in absolute neutrophil
count (34%).
DRUG INTERACTIONS
Anticancer Agents: Clinical studies of LYNPARZA with
other myelosuppressive anticancer agents, including DNA-damaging
agents, indicate a potentiation and prolongation of
myelosuppressive toxicity.
CYP3A Inhibitors: Avoid coadministration of strong or
moderate CYP3A inhibitors when using LYNPARZA. If a strong or
moderate CYP3A inhibitor must be coadministered, reduce the dose of
LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice,
Seville oranges, and Seville orange juice during LYNPARZA
treatment.
CYP3A Inducers: Avoid coadministration of strong or
moderate CYP3A inducers when using LYNPARZA.
USE IN SPECIFIC POPULATIONS
Lactation: No data are available regarding the presence
of olaparib in human milk, its effects on the breastfed infant or
on milk production. Because of the potential for serious adverse
reactions in the breastfed infant, advise a lactating woman not to
breastfeed during treatment with LYNPARZA and for 1 month after
receiving the final dose.
Pediatric Use: The safety and efficacy of LYNPARZA have
not been established in pediatric patients.
Hepatic Impairment: No adjustment to the starting dose is
required in patients with mild or moderate hepatic impairment
(Child-Pugh classification A and B). There are no data in patients
with severe hepatic impairment (Child-Pugh classification C).
Renal Impairment: No dosage modification is recommended
in patients with mild renal impairment (CLcr 51-80 mL/min estimated
by Cockcroft-Gault). In patients with moderate renal impairment
(CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice
daily. There are no data in patients with severe renal impairment
or end-stage renal disease (CLcr ≤30 mL/min).
INDICATIONS
LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor
indicated:
First-Line Maintenance BRCAm Advanced Ovarian Cancer For
the maintenance treatment of adult patients with deleterious or
suspected deleterious germline or somatic BRCA-mutated (gBRCAm or
sBRCAm) advanced epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in complete or partial response to
first-line platinum-based chemotherapy. Select patients for therapy
based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance HRD Positive Advanced Ovarian Cancer
in Combination with Bevacizumab
In combination with bevacizumab for the maintenance treatment of
adult patients with advanced epithelial ovarian, fallopian tube or
primary peritoneal cancer who are in complete or partial response
to first-line platinum-based chemotherapy and whose cancer is
associated with homologous recombination deficiency (HRD) positive
status defined by either:
- a deleterious or suspected deleterious BRCA mutation,
and/or
- genomic instability
Select patients for therapy based on an FDA-approved companion
diagnostic for LYNPARZA.
Maintenance Recurrent Ovarian Cancer For the maintenance
treatment of adult patients with recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer, who are in complete
or partial response to platinum-based chemotherapy.
Advanced gBRCAm Ovarian Cancer For the treatment of adult
patients with deleterious or suspected deleterious germline
BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated
with 3 or more prior lines of chemotherapy. Select patients for
therapy based on an FDA-approved companion diagnostic for
LYNPARZA.
gBRCAm, HER2-Negative Metastatic Breast Cancer For the
treatment of adult patients with deleterious or suspected
deleterious gBRCAm, human epidermal growth factor receptor 2
(HER2)-negative metastatic breast cancer who have been treated with
chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
Patients with hormone receptor (HR)-positive breast cancer should
have been treated with a prior endocrine therapy or be considered
inappropriate for endocrine therapy. Select patients for therapy
based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance gBRCAm Metastatic Pancreatic
Cancer For the maintenance treatment of adult patients with
deleterious or suspected deleterious gBRCAm metastatic pancreatic
adenocarcinoma whose disease has not progressed on at least 16
weeks of a first-line platinum-based chemotherapy regimen. Select
patients for therapy based on an FDA-approved companion diagnostic
for LYNPARZA.
HRR Gene-mutated Metastatic Castration-Resistant Prostate
Cancer For the treatment of adult patients with deleterious or
suspected deleterious germline or somatic homologous recombination
repair (HRR) gene-mutated metastatic castration-resistant prostate
cancer (mCRPC) who have progressed following prior treatment with
enzalutamide or abiraterone. Select patients for therapy based on
an FDA-approved companion diagnostic for LYNPARZA.
Please click here for complete Prescribing Information,
including Patient Information (Medication Guide).
Early breast cancer Breast cancer is the most common
cancer among women worldwide and an estimated 90% of all breast
cancer is diagnosed at an early stage.12,13 Breast cancer is one of
the most biologically diverse tumor types with various factors
fuelling its development and progression.14 The discovery of
biomarkers in the development of breast cancer has greatly impacted
scientific understanding of the disease.15
BRCA1 and BRCA2 BRCA1 and BRCA2 (breast cancer
susceptibility genes 1/2) are human genes that produce proteins
responsible for repairing damaged DNA and play an important role
maintaining the genetic stability of cells. When either of these
genes is mutated or altered such that its protein product either is
not made or does not function correctly, DNA damage may not be
repaired properly, and cells become unstable. As a result, cells
are more likely to develop additional genetic alterations that can
lead to cancer and confer sensitivity to PARP inhibitors including
LYNPARZA.16-19
OlympiA OlympiA is a Phase III, double-blind, parallel
group, placebo-controlled, multicenter trial testing the efficacy
and safety of LYNPARZA tablets versus placebo as adjuvant treatment
in patients with gBRCAm high-risk HER2-negative early breast
cancer, who have completed definitive local treatment and
neoadjuvant or adjuvant chemotherapy. The primary endpoint of the
trial is iDFS defined as time from randomization to date of first
treatment failure that is loco-regional or distant recurrence or
new cancer or death from any cause.1
NRG Oncology NRG Oncology is a network group funded by
the NCI, a part of the National Institutes of Health. All of the
NCI funded network groups participated in the trial. The NCI and
AstraZeneca are collaborating under a Cooperative Research and
Development Agreement.
NRG Oncology brings together the National Surgical Adjuvant
Breast and Bowel Project, the Radiation Therapy Oncology Group, and
the Gynecologic Oncology Group, with the mission to improve the
lives of cancer patients by conducting practice-changing
multi-institutional clinical and translational research.
BIG The Breast International Group (BIG) is an
international not-for-profit organization for academic breast
cancer research groups from around the world, based in Brussels,
Belgium.
Founded by leading European opinions leaders in 1999, the
organization aims to address fragmentation in European breast
cancer research and now represents a network of over 55 like-minded
research groups affiliated with specialized hospitals, research
centers and leading experts across approximately 70 countries on
six continents.
BIG’s research is supported in part by its philanthropy unit,
known as BIG against breast cancer, which is used to interact with
the general public and donors, and to raise funds for BIG’s purely
academic breast cancer trials and research programs.
FSTRF Frontier Science & Technology Research
Foundation (FSTRF) is a non-profit, research organization which
supports research networks, pharmaceutical companies and
investigators to conduct scientifically meaningful high-quality
clinical trials. The OlympiA trial involved research staff in the
US and in the Affiliate office in Scotland.
FSTRF works with scientists and technicians in more than 800
laboratories, universities and medical centers around the world to
provide a comprehensive range of research services throughout the
clinical trial process including design, analysis and
reporting.
Through its work, FSTRF aims to advance the application of
statistical science and practice and data management techniques in
science, healthcare and education.
LYNPARZA LYNPARZA (olaparib) is a first-in-class PARP
inhibitor and the first targeted treatment to block DNA damage
response (DDR) in cells/tumors harboring a deficiency in homologous
recombination repair (HRR), such as mutations in BRCA1 and/or
BRCA2. Inhibition of PARP with LYNPARZA leads to the trapping of
PARP bound to DNA single-strand breaks, stalling of replication
forks, their collapse and the generation of DNA double-strand
breaks and cancer cell death. LYNPARZA is being tested in a range
of PARP-dependent tumor types with defects and dependencies in the
DDR pathway.
LYNPARZA, which is being jointly developed and commercialized by
AstraZeneca and Merck, has been used to treat over 40,000 patients
worldwide. LYNPARZA has the broadest and most advanced clinical
trial development program of any PARP inhibitor, and AstraZeneca
and Merck are working together to understand how it may affect
multiple PARP-dependent tumors as a monotherapy and in combination
across multiple cancer types. LYNPARZA is the foundation of
AstraZeneca's industry-leading portfolio of potential new medicines
targeting DDR mechanisms in cancer cells.
The AstraZeneca and Merck strategic oncology
collaboration In July 2017, AstraZeneca and Merck & Co.,
Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada,
announced a global strategic oncology collaboration to co-develop
and co-commercialize LYNPARZA, the world’s first PARP inhibitor,
and selumetinib, a mitogen-activated protein kinase (MEK)
inhibitor, for multiple cancer types. Working together, the
companies will develop LYNPARZA and selumetinib in combination with
other potential new medicines and as monotherapies. Independently,
the companies will develop LYNPARZA and selumetinib in combination
with their respective PD-L1 and PD-1 medicines.
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 selective
estrogen receptor degrader (SERD) and potential new medicine
camizestrant (AZD9833). PARP inhibitor, LYNPARZA is a targeted
treatment option for patients with germline BRCA-mutated
HER2-negative metastatic breast cancer. AstraZeneca with Merck
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 state.
Building on the first approval of fam-trastuzumab
deruxtecan-nxki, a HER2-directed antibody-drug conjugate (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 LYNPARZA and fam-trastuzumab
deruxtecan-nxki, assessing 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 has a deep-rooted
heritage in oncology and offers a quickly growing portfolio of new
medicines that has the potential to transform patients’ lives and
the Company’s future. With seven new medicines launched between
2014 and 2020, and a broad pipeline of small molecules and
biologics in development, the Company is committed to advance
oncology as a key growth driver for AstraZeneca focused on lung,
ovarian, breast and blood cancers.
By harnessing the power of six scientific platforms –
Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response,
Antibody Drug Conjugates, Epigenetics, and Cell Therapies – and by
championing the development of personalized combinations,
AstraZeneca has the vision to redefine cancer treatment and, one
day, eliminate cancer as a cause of death.
AstraZeneca AstraZeneca is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialization of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. AstraZeneca operates in over 100 countries and
its innovative medicines are used by millions of patients
worldwide. For more information, please visit astrazeneca-us.com
and follow the Company on Twitter @AstraZenecaUS.
References 1. ClinicalTrials.gov. Olaparib as Adjuvant
Treatment in Patients with Germline BRCA Mutated High Risk HER2
Negative Primary Breast Cancer (OlympiA). Available at
https://clinicaltrials.gov/ct2/show/NCT02032823. Accessed February
2021. 2. GLOBOCAN. Breast Cancer. Available at
https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf.
Accessed February 2021. 3. Gomes M.C, et al. Prevalence of BRCA1
and BRCA2 Mutations in Breast Cancer Patients from Brazil. Breast
Cancer Res Treat. 2007 Jul;103(3):349-53. 4. Hernandez J.E, et al.
Prevalence of BRCA1 and BRCA2 Mutations in Unselected Breast Cancer
Patients from Medellín, Colombia. Hered Cancer in Clin Pract.
2014;12:11. 5. Bu R, et al. Identification of Novel BRCA Founder
Mutations in Middle Eastern Breast Cancer Patients Using Capture
and Sanger Sequencing Analysis. Int J Cancer. 2016;139:1091-1097.
6. Abugattas J, et al. Prevalence of BRCA1 and BRCA2 Mutations in
Unselected Breast Cancer Patients From Peru. Clin Genet. 2015
October;88(4):371-375. 7. Kast K, et al. Prevalence of BRCA1/2
Germline Mutations in 21,401 Families with Breast and Ovarian
Cancer. J Med Genet. 2016;53:465-471. 8. Winter C, et al. Targeted
Sequencing of BRCA1 and BRCA2 Across a Large Unselected Breast
Cancer Cohort Suggests That One-third of Mutations Are Somatic. Ann
Oncol. 2016;27:1532-1538. 9. Hoberg-Vetti H, et al. BRCA1/2 Testing
in Newly Diagnosed Breast and Ovarian Cancer Patients Without Prior
Genetic Counselling: the DNA-BONus Study. Eur J HumGenetic.
2016;24:881-888. 10. Kim R, et al. Incidence of germline BRCA1- and
BRCA2-mutated Breast Cancer in the US. SABCS. 2017;poster P5-08-28.
11. National Breast Cancer Foundation. BRCA: The Breast Cancer
Gene. Available at
https://www.nationalbreastcancer.org/what-is-brca. Accessed
February 2021. 12. SEER. SEER Cancer Statistics Review, 1975-2013.
Available at http://seer.cancer.gov/csr/1975_2013/. Accessed
February 2021. 13. Bertozzi S, et al. Biomarkers in Breast Cancer.
Intechopen. 2018. 14. Yersal O, and Barutca S. Biological Subtypes
of Breast Cancer: Prognostic and therapeutic implications. World J
Clin Oncol. 2014;5(3):412-424. 15. Rivenbark A, et al. Molecular
and Cellular Heterogeneity in Breast Cancer: Challenges for
Personalized Medicine. Am J Pathol. 2013;183(4):1113-1124. 16. Roy
R, et al. BRCA1 and BRCA2: Different Roles in a Common Pathway of
Genome Protection. Nat Rev Cancer. 12(1):68-78. 17. Wu J, et al.
The Role of BRCA1 in DNA Damage Response. Protein Cell.
2010;1(2):117-123. 18. Gorodetska I, et al. BRCA Genes: The Role in
Genome Stability, Cancer Stemness and Therapy Resistance. J Cancer.
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The Underlying Mechanisms and Clinical Implications. Mol Cancer.
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