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
2019
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
significantly delayed disease progression
26 February 2019 07:00 GMT
Lynparza significantly delayed disease progression as
1st-line maintenance treatment in germline BRCA-mutated metastatic pancreatic
cancer
Phase III POLO trial met its primary endpoint of progression-free
survival
AstraZeneca and MSD's Lynparza is the first PARP inhibitor to
demonstrate
benefit in gBRCAm metastatic pancreatic cancer in a Phase III
trial
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck
& Co., Inc. inside the US and Canada) today announced positive
results from the Phase III POLO trial.
Results from the trial showed a statistically-significant and
clinically-meaningful improvement in progression-free survival
(PFS) with Lynparza (olaparib) vs. placebo. The safety and
tolerability profile of Lynparza was consistent with previous
trials.
POLO is a randomised, double-blinded, placebo-controlled trial
exploring the efficacy of Lynparzatablets as 1st-line maintenance monotherapy in
patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas
(pancreatic cancer) whose disease has not progressed on
platinum-based chemotherapy.
José Baselga, Executive Vice President, Research and
Development, Oncology, said: "This is the first positive Phase III
trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic cancer, a
devastating disease with critical unmet need. The results of POLO
provide further evidence of the clinical benefit
of Lynparza across a variety of BRCA-mutated tumour types. We will discuss these
results with global health authorities as soon as
possible."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "Trials like POLO demonstrate the shared commitment of MSD
and AstraZeneca to assess treatments for difficult-to-treat
cancers. The clinically-meaningful results of this trial
potentially support the value of testing for
germline BRCA mutations in patients with metastatic
pancreatic cancer."
AstraZeneca and MSD plan to present the full data from the trial at
a forthcoming medical meeting.
About POLO
POLO is a Phase III randomised, double-blinded, placebo-controlled,
multicentre trial of Lynparzatablets (300mg twice daily) as maintenance
monotherapy vs. placebo. The trial randomised 154 patients with
gBRCAm metastatic pancreatic cancer whose disease had
not progressed on 1st-line platinum-based chemotherapy. Patients
were randomised (3:2) to receive Lynparza or placebo until disease progression. The
primary endpoint was PFS and key secondary endpoints included
overall survival, time to second disease progression, overall
response rate, disease control rate and health-related quality of
life.
About Lynparza
Lynparza (olaparib) is a
first-in-class PARP inhibitor and the first targeted treatment to
block DNA damage response in cells/tumours harbouring a deficiency
in homologous recombination repair (HRR), such as mutations
in BRCA1 and/or BRCA2. 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 PARP-dependent tumour types with defects
and dependencies in the DDR.
Lynparza, which is being
jointly developed and commercialised by AstraZeneca and MSD, is
approved for multiple indications in 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 pancreatic cancer
Pancreatic cancer is the 12th most common cancer
worldwide,1 with
466,000 new cases in 2018 alone.1 Germline BRCA-mutated
pancreatic cancer accounts for five to seven percent of all cases
globally.2 With
the worst survival rate of the most common
cancers,3 it
is the 4th leading cause of cancer death,4 and
less than seven percent of patients survive more than five years
after diagnosis.3 Early
diagnosis of pancreatic cancer is difficult, as often there are no
symptoms until it is too late.5 Around
80% of patients are diagnosed at the metastatic
stage.6
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 astrazeneca.com and
follow us on Twitter@AstraZeneca.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. World Cancer Research Fund International. Pancreatic cancer
statistics. Accessed February 2019 from https://www.wcrf.org/dietandcancer/cancer-trends/pancreatic-cancer-statistics
2. Holter S et al. Journal of Clinical
Oncology. 2015; 33;
3124-3129
3. Pancreatic Cancer Action. Facts and statistics. Accessed
February 2019 from https://pancreaticcanceraction.org/about-pancreatic-cancer/medical-professionals/stats-facts/facts-and-statistics/
4. Hidalgo M et al. Addressing the challenges of pancreatic cancer:
future directions for improving outcomes. 2015: Vol 15, Issue 1,
Pg. 8-18
5. Pancreatic Cancer UK. Signs and symptoms if pancreatic cancer.
Accessed February 2019 from https://www.pancreaticcancer.org.uk/information-and-support/facts-about-pancreatic-cancer/signs-and-symptoms-of-pancreatic-cancer/
6. Pancreatic Cancer. Some key facts. Accessed February 2019
from https://www.pancreaticcancer.org.uk/media/409815/mp-pancreatic-cancer-briefing-notes.pdf
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:
26 February
2019
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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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