Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of July
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Lynparza
approved in Japan for BRCAm breast cancer
02 July 2018 07:00BST
Lynparza
approved in Japan for
BRCA-mutated metastatic breast
cancer
Lynparza is the first and only PARP inhibitor approved for use
beyond ovarian cancer
Second approval in Japan for AstraZeneca and MSD's
Lynparza
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck:
known as MSD outside the US and Canada) today announced that
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has
approved Lynparza (olaparib) tablets for use in patients with
unresectable or recurrent BRCA-mutated (BRCAm), human epidermal growth factor receptor
2 (HER2) negative breast cancer who have received
prior chemotherapy. Patients are selected for therapy based on an
approved companion diagnostic.
Dave
Fredrickson, Executive Vice President, Head of the Oncology
Business Unit at AstraZeneca, said: "Earlier this year,
Lynparza became the first
PARP inhibitor available in Japan for advanced ovarian cancer. Now
patients in Japan with BRCA-mutated, metastatic breast cancer
will also have the opportunity to benefit from Lynparza. This latest approval
underlines our ongoing efforts to make Lynparza available across multiple
cancers as quickly as possible to patients around the
world."
Roy
Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "Metastatic breast cancer is a complex disease with remaining
unmet medical need. This approval is significant for breast cancer
patients as the evaluation of BRCA mutations, in addition to hormone
receptor and HER2 status, now becomes an important step in the
management of the disease."
The approval is based on data from the randomised,
open-label, Phase III OlympiAD
trial, which tested
Lynparza
vs chemotherapy. Patients were
selected for therapy based upon a confirmed BRCA mutation. In the trial, Lynparza significantly prolonged progression-free survival
(PFS) compared with chemotherapy, reducing the risk of disease
progression or death by 42% (HR 0.58; 95% CI 0.43-0.80; p=0.0009,
median PFS was 7.0 months with Lynparza vs 4.2 months with
chemotherapy).
Lynparza was generally well
tolerated with the majority of adverse events (AEs) reported as
mild to moderate with a lower rate of Grade 3 or higher AEs
compared with chemotherapy (36.6% vs 50.5%). The most common
AEs were nausea (50.2%), anaemia (32.2%) and fatigue
(22.4%).
Lynparza is also approved in
Japan as maintenance treatment for women with platinum-sensitive
relapsed ovarian cancer, regardless of BRCA mutation status. In Japan, the co-promotion
of Lynparza by both companies will begin on 1 July
2018.
About OlympiAD
OlympiAD was a randomised, open-label, multicentre Phase III trial
assessing the efficacy and safety of Lynparza tablets (300 mg twice daily) compared to
physician's choice of chemotherapy (capecitabine, eribulin, or
vinorelbine) in 302 patients with HER2-negative metastatic breast
cancer with germline BRCA1 or BRCA2 mutations, which are confirmed or suspected to be
deleterious. The international trial was conducted in 19 countries
across Europe, Asia, North America and South
America.
Patients in the OlympiAD trial had HER2-negative
gBRCA1- or gBRCA2-mutated breast cancer, which was hormone-receptor
positive (HR+) or triple negative, and received Lynparza for metastatic disease. Approximately half of the
patients in the Lynparza and chemotherapy arm of the trial were HR+
(n=152), and approximately half were triple negative (n=150). Among
the 205 patients treated with Lynparza, the median age was 44 years (range: 22 to 76).
Before enrolment, patients had prior treatment with an
anthracycline (unless contraindicated) and a taxane chemotherapy
either in the neoadjuvant, adjuvant or metastatic setting and no
more than two prior lines of chemotherapy for metastatic disease.
HR+ patients had received at least one endocrine medicine or were
not eligible for endocrine medicines. Prior treatments with
endocrine medicines were not counted as prior lines of
chemotherapy.
The primary endpoint of the trial was PFS as measured by a Blinded
Independent Central Review. Secondary endpoints included overall
survival, time to second progression or death, objective response
rate, and effect on health-related quality of life.
About BRCA mutations
BRCA1 and BRCA2 are human genes that produce proteins
responsible for repairing damaged DNA and play an important role in
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.
About breast cancer in Japan
In Japan, breast cancer is the fifth leading cause of death among
women.[1]
In Japanese women, breast cancer
incidence peaks in the late forties, whereas in the US and Europe
the peak incidence is in women over 60 years of
age.[2]
Despite more treatment options
becoming available during the past three decades, there is
currently no cure for patients diagnosed with metastatic (Stage IV)
breast cancer.[3]
In Japan, 5-year and 10-year relative
survival rates for patients with Stage IV breast cancer are as low
as 32.6% and 15.6%, respectively.[4]
Therefore, the primary aim of
treatment is to slow progression of the disease for as long as
possible and improve or maintain a patient's quality of
life.5
About Lynparza
Lynparza (olaparib) is the first-in-class PARP inhibitor and
the first targeted treatment to potentially exploit DNA damage
response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill
cancer cells. Specifically, in vitro studies have shown that
Lynparza-induced
cytotoxicity may involve inhibition of PARP-enzymatic activity and
increased formation of PARP-DNA complexes, resulting in DNA damage
and cancer cell death. Lynparza is being tested in a range of
DDR-deficient tumour types.
Lynparza, which is being jointly developed and
commercialised by AstraZeneca and MSD, is approved for advanced ovarian
cancer and metastatic breast cancer and has been used in over
20,000 patients. Lynparza
has the broadest and most advanced clinical trial development
programme of any PARP inhibitor and AstraZeneca and MSD are working
together to deliver it as quickly as possible to more patients
across multiple cancer types. Lynparza is the foundation of
AstraZeneca's industry-leading portfolio of potential new medicines
targeting DDR mechanisms in cancer cells.
About the AstraZeneca and MSD Strategic Oncology
Collaboration
In July
2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US,
known as MSD outside the United States and Canada, announced a
global strategic oncology collaboration to co-develop and
co-commercialise Lynparza,
the world's first PARP inhibitor and potential new medicine
selumetinib, a 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.
About 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 at least six new
medicines to be launched between 2014 and 2020, and a broad
pipeline of small molecules and biologics in development, we are
committed to advance Oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to our core capabilities, we actively pursue innovative
partnerships and investments that accelerate the delivery of our
strategy, as illustrated by our investment in Acerta Pharma in
haematology.
By
harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment 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 commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. The Company also is selectively active
in the areas of autoimmunity, neuroscience and infection.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com
and follow us on Twitter
@AstraZeneca.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
[1] IARC, Globocan population fact sheets, Japan. Accessed
June 2018 from
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx
[2] Kunichika M et al Cost of illness of breast cancer in
Japan: trends and future projections. BMC Research Notes, 2015; 8:
539
[3] O'Shaughnessy J. Extending Survival with Chemotherapy in
Metastatic Breast Cancer. The Oncologist
2005;10(3):20-29.
[4] Maeda S et al Efficacy and safety of eribulin as
first to third line treatment in patients with advanced or
metastatic breast cancer previously treated with anthracyclines and
taxanes. The Breast, Vol 32, April 2017, Pg 66-72
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
02 July
2018
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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