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 December
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
meets primary endpoint in SOLO-3 trial
20 December 2018 07:05 GMT
Lynparza meets
primary endpoint in Phase III SOLO-3 trial for the treatment of
relapsed BRCA-mutated advanced ovarian
cancer
AstraZeneca and MSD's Lynparza significantly improved objective
response rate compared to chemotherapy in platinum-sensitive
relapsed patients who had two or more prior lines of
chemotherapy
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, open-label, controlled, Phase III
SOLO-3 trial of Lynparza (olaparib) tablets in 266 patients with
relapsed ovarian cancer after two or more lines of treatment. The
trial was conducted as a post-approval commitment in
agreement with the US Food and Drug Administration (FDA). This
is the fourth Phase III trial to demonstrate a positive result
for Lynparza. AstraZeneca and MSD now plan to discuss
these results with the FDA.
Results from the trial showed BRCA-mutated (BRCAm) advanced ovarian cancer patients treated
with Lynparza following two or more prior lines of
chemotherapy demonstrated a statistically-significant and
clinically-meaningful improvement in the primary endpoint of
objective response rate (ORR) and the key secondary endpoint of
progression-free survival (PFS) compared to chemotherapy. The
safety and tolerability profile of Lynparza was consistent with previous
trials.
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer, said: "We are very excited about SOLO-3,
which is the first Phase III trial for a PARP inhibitor to
demonstrate a positive result versus chemotherapy in advanced
ovarian cancer where effective options are
needed. We look forward
to sharing the full results at a forthcoming medical
meeting."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "Following on the US approval of Lynparza as
first-line maintenance therapy for certain patients
with BRCAm
advanced ovarian cancer, the results of SOLO-3 further reinforce
the efficacy of Lynparza in
relapsed patients with gBRCAm
advanced ovarian cancer following multiple lines of
chemotherapy."
About SOLO-3
SOLO-3 is a Phase III randomised, open-label, controlled,
multicentre trial to evaluate the efficacy and safety
of Lynparza tablets following two or more prior lines of
chemotherapy. The trial randomised 266 patients with a deleterious
or suspected deleterious BRCA1 or BRCA2 mutation. Eligible patients were randomised
(2:1) to receive Lynparza 300mg tablets twice daily or physician's
choice single-agent chemotherapy (paclitaxel, topotecan, pegylated
liposomal doxorubicin or gemcitabine). The primary endpoint
was ORR by blinded independent central review and key
secondary endpoints included progression-free survival, time to
second disease progression or death and overall
survival.
About Lynparza
Lynparza 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. Inhibition of PARP 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 being tested in a range of tumour types
with defects and dependencies in the DDR.
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:
20 December
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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