First PARP inhibitor to demonstrate overall
survival benefit in early breast cancer
AstraZeneca and Merck & Co., Inc., known as MSD outside the
US and Canada, today announced further positive results from the
OlympiA Phase III trial showed LYNPARZA® (olaparib) demonstrated a
statistically significant and clinically meaningful improvement in
overall survival (OS) versus placebo in the adjuvant treatment of
patients with germline BRCA-mutated (gBRCAm) high-risk human
epidermal growth factor receptor 2 (HER2)-negative early breast
cancer who had completed local treatment and standard neoadjuvant
or adjuvant chemotherapy.
These results were presented today at a European Society for
Medical Oncology Virtual Plenary. The OlympiA trial is led by the
Breast International Group (BIG) in partnership with the Frontier
Science & Technology Research Foundation, NRG Oncology,
AstraZeneca and Merck.1
In the key secondary endpoint of OS, LYNPARZA reduced the risk
of death by 32% versus placebo (based on a HR of 0.68; 98.5% CI
0.47-0.97; p=0.009). LYNPARZA improved the three-year survival rate
to 92.8% versus 89.1% for those on placebo. At four years, the
survival benefit was maintained with 89.8% of patients treated with
LYNPARZA alive versus 86.4% of those on placebo. The safety and
tolerability profile of LYNPARZA in this trial was in line with
that observed in prior clinical trials.
Primary results from the OlympiA Phase III trial were first
presented during the 2021 American Society of Clinical Oncology
Annual Meeting and are published in The New
England Journal of Medicine.2 The OS data and the primary
results formed the basis for the recent approval by the US Food and
Drug Administration (FDA) of LYNPARZA in this setting.
Breast cancer is the most diagnosed cancer worldwide with an
estimated 2.3 million patients diagnosed in 2020.3 Nearly 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.4,5
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: “OlympiA’s latest
results are 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. OlympiA has now shown that olaparib not only
reduced the risk of recurrence but also improved overall survival
for women with high risk early-stage breast cancer and a BRCA1/2
mutation and is an exciting demonstration of the benefits of
targeting the specific biology of disease for these women.”
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: “These exciting results further support how
LYNPARZA could significantly change the way people with germline
BRCA-mutated early breast cancer are treated. The OlympiA trial is
the first time we’ve seen a PARP inhibitor deliver survival benefit
in early breast cancer, highlighting the importance of persistent
innovation in tackling cancer early.”
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, Merck Research Laboratories,
said: “The results from the OlympiA trial highlight that patients
with germline BRCA-mutated, HER2-negative, high-risk early breast
cancer can both live longer and with reduced risk of disease
recurrence when treated with LYNPARZA in the adjuvant setting,
compared to placebo. These data further reinforce the importance of
germline BRCA testing immediately after diagnosis to help identify
patients who may be eligible for treatment with 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 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
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.6 In the US, the 5-year survival 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).4 Despite advancements
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 years 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.1
The primary endpoint of the trial is invasive disease-free
survival defined as time from randomization to date of first
loco-regional or distant recurrence or new cancer or death from any
cause.1
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 opinion leaders in 1999, the
organization aims to address fragmentation in breast cancer
research and now represents a network of over 50 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.
NRG Oncology
NRG Oncology is a network group funded by the US National Cancer
Institute (NCI), a part of the National Institutes of Health. NRG
Oncology brings together the National Surgical Adjuvant Breast and
Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG),
and the Gynecologic Oncology Group (GOG), with the mission to
improve the lives of cancer patients by conducting
practice-changing multi-institutional clinical and translational
research. NRG Oncology sponsored OlympiA in the US and collaborated
with the other adult cancer clinical trials research groups funded
by the NCI, Alliance, ECOG/ACRIN and the Southwest Oncology Group.
The NCI and AstraZeneca are collaborating under a Cooperative
Research and Development Agreement between the parties.
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.10 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.10-13
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 and Japan
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 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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) 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. 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. Tutt ANJ, et al. Adjuvant Olaparib for Patients with BRCA1-
or BRCA2-Mutated Breast Cancer. N Engl J Med
2021;384:2394-2405.
3. 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.
4. 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 February 2021.
5. Cancer.gov. Early-stage breast cancer. Available at
https://www.cancer.gov/publications/dictionaries/cancer-terms/def/early-stage-breast-cancer.
Accessed February 2021.
6. 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 February 2021.
7. 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.
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. Roy R, et al. BRCA1 and BRCA2: different roles in a common
pathway of genome protection. Nat Rev Cancer. 2016;12(1):68-78.
11. Wu J, et al. The role of BRCA1 in DNA damage response.
Protein Cell 2010;1(2):117-123.
12. Gorodetska I, et al. BRCA Genes: The Role in Genome
Stability, Cancer Stemness and Therapy Resistance. Journal of
Cancer. 2019;10:2109-2127.
13. Li H, et al. PARP inhibitor resistance: the underlying
mechanisms and clinical implications. Molecular Cancer.
2020;19:1-16.
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