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 November
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
US FDA accepts
regulatory submission for Lynparza
12 November 2018 07:05 GMT
US FDA accepts regulatory submission
for Lynparza maintenance therapy in
newly-diagnosed, BRCA-mutated advanced ovarian
cancer
and grants Priority Review
Approval would expand use of AstraZeneca and MSD's Lynparza
to
patients in the 1st-line setting following platinum-based
chemotherapy
First US regulatory submission acceptance for a PARP
inhibitor
as a 1st-line maintenance treatment for advanced ovarian
cancer
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck:
known as MSD outside the US and Canada) today announced that the US
Food and Drug Administration (FDA) has accepted a supplemental New
Drug Application (sNDA) for Priority Review for the use
of Lynparza (olaparib) tablets as a maintenance
treatment in patients with
newly-diagnosed, BRCA-mutated
(BRCAm) advanced ovarian cancer who were in complete or
partial response following 1st-line standard platinum-based
chemotherapy. A Prescription Drug User Fee Act (PDUFA) date is set
for the first quarter of 2019.
This is the first US regulatory submission acceptance for a poly
ADP-ribose polymerase (PARP) inhibitor in the 1st-line maintenance
setting for advanced ovarian cancer, and if approved will be the
fourth indication for Lynparza in the US.
This submission was based on positive results from the pivotal
Phase III SOLO-1 trial. The trial showed a
statistically-significant and clinically-meaningful improvement in
progression-free survival (PFS) for Lynparza compared to placebo, reducing the risk of
disease progression or death by 70% in patients with
newly-diagnosed, BRCAm advanced ovarian cancer who were in
complete or partial response to platinum-based
chemotherapy (HR 0.30 [95% CI 0.23-0.41], p<0.001). Of
those receiving Lynparza, 60% remained progression-free at 36
months compared to 27% of women in the placebo arm. These data were
recently presented for the first time at
the ESMO 2018
Congress (European Society
for Medical Oncology) and published online in
the New England Journal of
Medicine.
Lynparza is currently
approved in over 60 countries for the treatment
of platinum-sensitive relapsed ovarian cancer regardless
of BRCA status. It is also approved in several
countries, including the US and Japan, for
germline BRCAm HER2-negative metastatic breast cancer -
regulatory reviews are underway in the EU, Japan and other
markets.
About SOLO-1
SOLO-1 is a Phase III randomised, double-blinded,
placebo-controlled, multicentre trial to evaluate the efficacy and
safety of Lynparza tablets (300mg twice daily) as maintenance
monotherapy compared with placebo, in newly-diagnosed patients
with BRCAm advanced ovarian cancer following platinum-based
chemotherapy. The trial randomised 391 patients with a deleterious
or suspected deleterious BRCA1 or BRCA2 mutation who were in clinical
complete or partial response following platinum-based chemotherapy. Patients
were randomised (2:1) to receive Lynparza or placebo for up to two years or until
disease progression (at the investigator's discretion). The primary
endpoint was PFS and key secondary endpoints included time to
second disease progression or death, time to first subsequent
treatment and overall survival.
About Lynparza
Lynparza (olaparib) is a
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
worldwide. Lynparza has the broadest and most advanced clinical
trial development programme of any PARP inhibitor and AstraZeneca
and MSD are working together to understand how it may affect
multiple PARP-dependent tumours 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.
About ovarian cancer
Ovarian
cancer is a leading cause of cancer death in women worldwide, with
a five-year survival rate of 19%.[i] In
2018, there were over 295,000 new cases diagnosed and around
185,000 deaths.[ii] For
newly-diagnosed advanced ovarian cancer, the primary aim of
treatment is to delay progression of the disease for as long as
possible and maintain the patient's quality of life with the intent
of achieving complete remission or cure.[iii],[iv],[v],[vi]
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 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. 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] American Cancer Society. Survival
Rates for Ovarian Cancer, by Stage. Available at:
https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed: October 2018
[ii] Globocan 2018
http://gco.iarc.fr/
[iii] Moore K et al. Maintenance
Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.
Presented at ESMO October 2018
[iv] Raja, F. A., Chopra, N.
& Ledermann, J. A. Optimal first-line treatment in ovarian
cancer. Ann. Oncol. Off. J. Eur. Soc. Med. Oncol. 23 Suppl 10,
x118-127 (2012
[v] NHS
Choices, Ovarian Cancer Accessed
https://www.nhs.uk/conditions/ovarian-cancer/treatment/ in
September 2018
[vi] Ledermann.et al. 2013.
Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO
Clinical Practice.
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:
12 November
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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