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 (February
2017)
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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This announcement contains inside information
17
February 2017, 07:00 GMT
LYNPARZA MEETS PRIMARY ENDPOINT IN PHASE III
TRIAL IN BRCA-MUTATED METASTATIC BREAST CANCER
Lynparza provided a statistically-significant improvement in
progression-free survival compared to chemotherapy
First positive randomised trial to evaluate the efficacy and safety
of a PARP inhibitor beyond ovarian cancer
AstraZeneca
today announced positive results from its Phase III OLYMPIAD trial
comparing Lynparza (olaparib) tablets (300mg twice daily) to
physician's choice of a standard of care chemotherapy in the
treatment of patients with HER2-negative metastatic breast cancer
harbouring germline BRCA1 or BRCA2 mutations. Patients treated with
Lynparza showed a statistically-significant and
clinically-meaningful improvement in progression-free survival
(PFS) compared with those who received chemotherapy (capecitabine,
vinorelbine or eribulin).
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "These results are
positive news for patients with BRCA-mutated metastatic breast
cancer, a disease with a high unmet need, and are the first
positive Phase III data for a PARP inhibitor beyond ovarian cancer.
This is highly encouraging for the development of our broad
portfolio which aims to treat multiple cancers by targeting DNA
damage response pathways."
Initial
findings from the OLYMPIAD study indicate that the safety profile
of Lynparza was consistent with previous studies.
A full
evaluation of the OLYMPIAD data is ongoing and the results will be
submitted for presentation at a forthcoming medical meeting.
AstraZeneca will be working with regulatory authorities to make
Lynparza available to patients with this type of breast
cancer.
About Metastatic Breast Cancer
Approximately
one in eight women are diagnosed with breast cancer. Of these
patients, approximately one-third are either diagnosed with or
progress to the metastatic stage of the disease.[i] Despite treatment
options increasing during the past three decades there is currently
no cure for patients diagnosed with metastatic breast cancer. Thus,
the primary aim of treatment is to slow progression of the disease
for as long as possible, improving or at least maintaining a
patient's quality of life.
About OLYMPIAD
OLYMPIAD
is a randomised, multi-center Phase III trial assessing the
efficacy and safety of Lynparza (300 mg twice daily) to
'physician's choice' chemotherapy (capecitabine, vinorelbine,
eribulin) in 302 patients with HER2-negative metastatic breast
cancer with germline BRCA1 or BRCA2 mutations, which are predicted
or suspected to be deleterious. The international study was
conducted in 19 countries from across Europe, Asia, North America
and South America.
The
primary endpoint of the trial was progression-free survival (PFS)
as measured by a Blinded Independent Central Review (BICR).
Secondary endpoints include overall survival (OS), time to second
progression or death (PFS2), objective response rate (ORR), and
effect on health-related quality of life (HRQoL).
About Germline BRCA mutations
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. 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. As a result, cells are more likely to develop additional
genetic alterations that can lead to cancer.[ii]
Specific
inherited mutations in BRCA1 and BRCA2 increase the risk of female
breast and ovarian cancers, and they have been associated with
increased risks of several additional types of cancer. Together,
BRCA1 and BRCA2 mutations account for about 20 to 25 percent of
hereditary breast cancers[iii] and about 5 to
10 percent of all breast cancers[iv]. In addition,
mutations in BRCA1 and BRCA2 account for around 15 percent of
ovarian cancers overall[v]. Breast and
ovarian cancers associated with BRCA1 and BRCA2 mutations tend to
develop at younger ages than their nonhereditary
counterparts.
About Lynparza
Lynparza
(olaparib) is an innovative, first-in-class oral poly ADP-ribose
polymerase (PARP) inhibitor that may
exploit tumour DNA damage response (DDR) pathway deficiencies
to preferentially kill
cancer cells. Lynparza is the foundation of AstraZeneca's
industry-leading portfolio of compounds targeting DNA damage
response (DDR) mechanisms in cancer cells.
Lynparza
is currently approved by regulatory health authorities in the EU
for use as monotherapy for the maintenance treatment of adult
patients with platinum-sensitive relapsed BRCA-mutated (germline
and/or somatic) high grade serous epithelial ovarian, fallopian
tube or primary peritoneal cancer who are in response (complete or
partial) to platinum-based chemotherapy. It is also approved in the
US as monotherapy in patients with deleterious or suspected
deleterious germline BRCA-mutated (as detected by an FDA-
test)
advanced ovarian cancer who have been treated with three or more
prior lines of chemotherapy.
Lynparza
is currently being investigated in another separate non-metastatic
breast cancer Phase III study called OLYMPIA. This study is still
open and recruiting patients internationally.
About AstraZeneca in Oncology
AstraZeneca
has a deep-rooted heritage in Oncology and offers a quickly growing
portfolio of new medicines that have the potential to transform
patients' lives and the Company's future. With at least 6 new
medicines to be launched between 2014 and 2020 and a broad pipeline
of small molecules and biologics in development, we are committed
to advancing Oncology as one of AstraZeneca's six Growth Platforms
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, the genetic
drivers of cancer 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 main
therapy areas - Oncology, Cardiovascular & Metabolic Diseases
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
[i] Dr
Joyce O'Shaughnessy; Extending Survival with Chemotherapy in MBC"
The Oncologist 2005:10
[ii]
NCI website - BRCA Fact-sheet … https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet
Last accessed January 2017
[iii]
Easton DF. How many more breast cancer predisposition genes are
there? Breast Cancer Research 1999; 1(1):14-17.
[iv]
Campeau PM, Foulkes WD, Tischkowitz MD. Hereditary breast cancer:
New genetic developments, new therapeutic avenues. Human Genetics
2008; 124(1):31-42.
[v] Pal
T, Permuth-Wey J, Betts JA, et al. BRCA1 and BRCA2 mutations
account for a large proportion of ovarian carcinoma cases. Cancer
2005; 104(12):2807-16.
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.
AstraZeneca
PLC
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Date:
17 February 2017
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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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