First and only approved medicine targeting
BRCA mutations in early breast cancer
New data show LYNPARZA demonstrated overall
survival benefit in early breast cancer
AstraZeneca and Merck & Co., Inc., known as MSD outside the
US and Canada, today announced LYNPARZA® (olaparib) has been
approved in the US for the adjuvant treatment of patients with
germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast
cancer who have already been treated with chemotherapy either
before or after surgery.
The approval by the US Food and Drug Administration (FDA) was
based on results from the OlympiA Phase III trial presented during
the 2021 American Society of Clinical Oncology cAnnual Meeting and
published in The New England Journal of Medicine.1
In the trial, LYNPARZA demonstrated a statistically significant
and clinically meaningful improvement in invasive disease-free
survival (iDFS), reducing the risk of invasive breast cancer
recurrences, second cancers or death, by 42% versus placebo (based
on a hazard ratio [HR] of 0.58; 95% confidence interval [CI]
0.46-0.74; p<0.0001).
New updated results from the OlympiA trial also showed LYNPARZA
demonstrated a statistically significant and clinically meaningful
improvement in the key secondary endpoint of overall survival (OS),
reducing the risk of death by 32% versus placebo (based on a HR of
0.68; 95% CI 0.50-0.91; p=0.0091). The safety and tolerability
profile of LYNPARZA in this trial was in line with that observed in
prior clinical trials. The OS data will be presented at an upcoming
European Society for Medical Oncology virtual plenary on March 16,
2022.
Breast cancer is the most diagnosed cancer worldwide with an
estimated 2.3 million patients diagnosed in 2020.2 Almost 91% of
all breast cancer patients in the US are diagnosed at an early
stage of disease and BRCA mutations are found in approximately
5-10% of patients.3,4
Professor Andrew Tutt, Global Chair of the OlympiA Phase III
trial and Professor of Oncology at The Institute of Cancer
Research, London and King’s College London, said: “Today’s approval
of olaparib is great news for patients with a specific inherited
form of breast cancer. Most breast cancers are identified in the
early stages and many patients will do very well, but for those
with higher risk disease at diagnosis, the risk of cancer returning
can be unacceptably high and new treatment options are needed.
OlympiA has shown that identifying a BRCA1/2 mutation in women with
high risk disease opens the additional option of eligibility for
olaparib treatment, which reduces the risk of recurrence and
improves survival for these breast cancer patients.”
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, AstraZeneca, said: “This important approval gives early-stage
breast cancer patients in the US with a germline BRCA mutation a
new targeted therapy option in the adjuvant setting starting today.
LYNPARZA reduces the risk of disease recurrence in these high-risk
patients and now new data confirm it also significantly extends
patients’ lives versus placebo. These data underline the importance
of germline BRCA testing as soon as possible after diagnosis to
identify patients that may be eligible for LYNPARZA.”
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, Merck Research Laboratories,
said: “For patients with germline BRCA-mutated, HER2-negative
high-risk early breast cancer, who often present with more
aggressive disease, today’s approval is an important step forward.
Compared to placebo, LYNPARZA as adjuvant treatment offers these
patients the potential to live longer without their cancer
recurring. We thank the patients, caregivers and healthcare
providers for their participation in the OlympiA trial.”
LYNPARZA is now indicated for the adjuvant treatment of adult
patients with deleterious or suspected deleterious gBRCAm
HER2-negative high-risk early breast cancer who have been treated
with neoadjuvant or adjuvant chemotherapy. Patients are to be
selected for treatment based on an FDA-approved companion
diagnostic test for LYNPARZA.
LYNPARZA is approved in the US, EU, Japan and several other
countries for the treatment of patients with gBRCAm, HER2-negative,
metastatic breast cancer previously treated with chemotherapy based
on results from the OlympiAD Phase III trial. In the EU, this
indication also includes patients with locally advanced breast
cancer.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
There are no contraindications for LYNPARZA.
WARNINGS AND PRECAUTIONS
Myelodysplastic Syndrome/Acute Myeloid Leukemia
(MDS/AML): Occurred in approximately 1.5% of patients exposed
to LYNPARZA monotherapy, and the majority of events had a fatal
outcome. The median duration of therapy in patients who developed
MDS/AML was 2 years (range: <6 months to >10 years). All of
these patients had previous chemotherapy with platinum agents
and/or other DNA-damaging agents, including radiotherapy.
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 0.8% of patients exposed to
LYNPARZA monotherapy, 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
who received 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%), urinary
tract infection (13%), thrombocytopenia (11%), and stomatitis
(11%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received 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
who received 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 who received 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 After 3 or
More Lines of Chemotherapy
Most common adverse reactions (Grades 1-4) in ≥20% of patients
who received 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 who received 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—Adjuvant Treatment of gBRCAm,
HER2-Negative, High-Risk Early Breast Cancer
Most common adverse reactions (Grades 1-4) in ≥10% of patients
who received LYNPARZA in the adjuvant setting for
OlympiA were: nausea (57%), fatigue (including asthenia)
(42%), anemia (24%), vomiting (23%), headache (20%), diarrhea
(18%), leukopenia (17%), neutropenia (16%), decreased appetite
(13%), dysgeusia (12%), dizziness (11%), and stomatitis (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA in the adjuvant setting for
OlympiA were: decrease in lymphocytes (77%), increase in
mean corpuscular volume (67%), decrease in hemoglobin (65%),
decrease in leukocytes (64%), and decrease in absolute neutrophil
count (39%).
ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast
Cancer
Most common adverse reactions (Grades 1-4) in ≥20% of patients
who received LYNPARZA in the metastatic setting for
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 who received LYNPARZA in the metastatic setting for
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
who received 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 who received 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
who received 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 who received 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.
Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early
Breast Cancer
For the adjuvant treatment of adult patients with deleterious or
suspected deleterious gBRCAm, human epidermal growth factor
receptor 2 (HER2)-negative high-risk early breast cancer who have
been treated with neoadjuvant or adjuvant 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 see complete Prescribing Information, including
Medication Guide.
Notes
Financial considerations
Following this approval for LYNPARZA in the US, AstraZeneca will
receive a regulatory milestone payment from Merck of $175m,
anticipated to be booked as Collaboration Revenue by the Company
during the first quarter of 2022.
Early breast cancer
Early breast cancer is defined as cancer confined to the breast
with or without regional lymph node involvement, and the absence of
distant metastatic disease.5 In the US, the 5-year survival rate is
99% for localized breast cancer (only found in the breast area) and
86% for regional breast cancer (cancer that has spread outside the
breast to nearby structures or lymph nodes).3
Despite advances in the treatment of early breast cancer, up to
30% of patients with high-risk clinical and/or pathologic features
recur within the first few years6, and patients with gBRCA
mutations are more likely to be diagnosed at a younger age than
those without these mutations.7
Breast cancer is one of the most biologically diverse tumor
types with various factors fuelling its development and
progression.8 The discovery of biomarkers in the development of
breast cancer has greatly impacted scientific understanding of the
disease.9
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.10
The primary endpoint of the trial is iDFS defined as time from
randomization to date of first locoregional or distant recurrence
or new cancer or death from any cause.11
The OlympiA Phase III trial is led by the Breast International
Group in partnership with the Frontier Science & Technology
Research Foundation, NRG Oncology, the US National Cancer
Institute, AstraZeneca and Merck. The trial is sponsored by NRG
Oncology in the US and by AstraZeneca outside the US.12
BRCA
BRCA1 and BRCA2 are human genes that produce proteins
responsible for repairing damaged DNA and play an important role
maintaining the genetic stability of cells.11
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.11-14
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 those with mutations in BRCA1 and/or BRCA2,
or those where deficiency is induced by other agents (such as new
hormonal agents – NHAs).
Inhibition of PARP proteins 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 currently approved in a number of countries across
PARP-dependent tumor types with defects and dependencies in the DDR
pathway including maintenance treatment of platinum-sensitive
relapsed ovarian cancer and as both monotherapy and in combination
with bevacizumab for the 1st-line maintenance treatment of
BRCA-mutated (BRCAm) and homologous recombination repair deficient
(HRD)-positive advanced ovarian cancer, respectively; for germline
BRCAm, HER2-negative metastatic breast cancer (in the EU this
includes locally advanced breast cancer); for germline BRCAm
metastatic pancreatic cancer; and HRR gene-mutated metastatic
castration-resistant prostate cancer (BRCAm only in the EU and
Japan).
LYNPARZA, which is being jointly developed and commercialized by
AstraZeneca and Merck, 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. The companies will develop LYNPARZA and
selumetinib in combination with their respective PD-L1 and PD-1
medicines independently.
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 SERD and potential new
medicine camizestrant.
The PARP inhibitor, LYNPARZA (olaparib), is an approved targeted
treatment option for early and metastatic breast cancer patients
with an inherited BRCA mutation. AstraZeneca with Merck continue to
research LYNPARZA in breast cancer patients with an inherited BRCA
mutation.
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, 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 catalyse 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. Tutt ANJ, et al. Adjuvant Olaparib for Patients with BRCA1-
or BRCA2-Mutated Breast Cancer. N Engl J Med
2021;384:2394-2405.
2. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN
Estimates of Incidence and Mortality Worldwide for 36 Cancers in
185 Countries. CA: A Cancer Journal for Clinicians.
2020;0:1-41.
3. American Cancer Society. Breast Cancer Facts & Figures
2019-2020. Available at
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancer-facts-and-figures-2019-2020.pdf.
Accessed January 2021.
4. Cancer.gov. Early-stage breast cancer. Available at
https://www.cancer.gov/publications/dictionaries/cancer-terms/def/early-stage-breast-cancer.
Accessed January 2021.
5. Union for International Cancer Control. Early-stage breast
cancer -2014 Review of Cancer Medicines on the WHO List of
Essential Medicines. Available at
https://www.who.int/selection_medicines/committees/expert/20/applications/EarlyStageBreast.pdf?ua=1.
Accessed January 2021.
6. Colleoni M, et al. Annual Hazard Rates of Recurrence for
Breast Cancer During 24 Years of Follow-Up: Results From the
International Breast Cancer Study Group Trials I to V. J Clin
Oncol. 2016 Mar 20; 34(9):927-935.
7. O'Shaughnessy J, et al. Prevalence of germline BRCA mutations
in HER2-negative metastatic breast cancer: global results from the
real-world, observational BREAKOUT study. Breast Cancer Research.
2020;22(114).
8. Yersal O, Barutca S. Biological subtypes of breast cancer:
Prognostic and therapeutic implications. World J Clin Oncol.
2014;5(3):412-424.
9. Rivenbark AG, et al. Molecular and Cellular Heterogeneity in
Breast Cancer: Challenges for Personalized Medicine. Am J Pathol.
2013;183:1113-1124.
10. 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 January
2021.
11. Roy R, et al. BRCA1 and BRCA2: different roles in a common
pathway of genome protection. Nat Rev Cancer. 2016;12(1):68-78.
12. Wu J, et al. The role of BRCA1 in DNA damage response.
Protein Cell 2010;1(2):117-123.
13. Gorodetska I, et al. BRCA Genes: The Role in Genome
Stability, Cancer Stemness and Therapy Resistance. Journal of
Cancer. 2019;10:2109-2127.
14. Li H, et al. PARP inhibitor resistance: the underlying
mechanisms and clinical implications. Molecular Cancer.
2020;19:1-16.
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AstraZeneca (NASDAQ:AZN)
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