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 June
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:
significant PFS 1st-line ovarian cancer
This announcement contains inside information
27 June 2018 07:00 BST
Lynparza significantly
delays disease progression in Phase III
1st-line SOLO-1 trial for ovarian cancer
Lynparza met primary endpoint of progression-free survival in women
with BRCA-mutated advanced ovarian cancer and showed a safety
profile consistent with previous trials
AstraZeneca and MSD's Lynparza is the only PARP inhibitor to
demonstrate significant activity in the 1st-line maintenance
setting
AstraZeneca
and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as
MSD outside the US and Canada) today announced positive results
from the randomised, double-blinded, placebo-controlled, Phase III
SOLO-1 trial of Lynparza
(olaparib) tablets.
Women
with BRCA-mutated
(BRCAm) advanced ovarian cancer treated
1st-line with Lynparza
maintenance therapy had a statistically-significant and
clinically-meaningful improvement in progression-free survival
compared to placebo. The safety and tolerability profile of
Lynparza was consistent
with previous trials. Based upon these data, AstraZeneca and MSD
plan to initiate discussions with health authorities regarding
regulatory submissions.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "For the first time, we
see a significant and clinically-impactful improvement in
progression-free survival in the 1st-line maintenance setting for
women with BRCA-mutated
ovarian cancer treated with a PARP inhibitor. The SOLO-1 data
reinforce the importance of knowing BRCA status at diagnosis, as this may
enable women with BRCA-mutated ovarian cancer to receive
Lynparza earlier. We would
like to thank the investigators, hospitals and most of all the
patients who took part in this trial, without whom medical
advancements would not be possible."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "Building on the strong data we've seen with
Lynparza
to date, the data from
SOLO-1 reinforces Lynparza's
ability to provide
meaningful disease control with a well-characterised safety and
tolerability profile. We look forward to presenting the full data
set for SOLO-1 at a future medical meeting and working with
regulatory authorities to bring Lynparza
to women with ovarian
cancer in the 1st-line maintenance setting as quickly as
possible."
Additionally,
the ongoing GINECO/ENGOTov25 Phase III trial, PAOLA-1, is testing
the effect of Lynparza in
combination with bevacizumab as a 1st-line maintenance treatment in
women with newly-diagnosed advanced ovarian cancer, regardless of
their BRCA status. Results
are expected in 2019.
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 as
1st-line maintenance monotherapy compared with placebo, in patients
with BRCAm advanced ovarian
cancer. 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. Eligible patients were randomised (2:1) to receive
Lynparza 300mg tablets
twice daily or placebo tablets twice daily. The primary endpoint
was progression-free survival and key
secondary endpoints included time to second disease progression or
death and overall survival.
About ovarian cancer
Worldwide, ovarian cancer is the seventh most common cancer and the
eighth leading cause of cancer death in women. The five-year
survival rate for ovarian cancer worldwide is 30-40%. In 2012,
there were nearly 239,000 new cases diagnosed and around 152,000
deaths. 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.
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 Lynparza
Lynparza (olaparib) was 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 worldwide. 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
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AstraZeneca PLC
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:
27 June
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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