<SEC-DOCUMENT>0001654954-19-001971.txt : 20190226
<SEC-HEADER>0001654954-19-001971.hdr.sgml : 20190226
<ACCEPTANCE-DATETIME>20190226063445
ACCESSION NUMBER:		0001654954-19-001971
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20190226
FILED AS OF DATE:		20190226
DATE AS OF CHANGE:		20190226

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		19631577

	BUSINESS ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ZENECA GROUP PLC
		DATE OF NAME CHANGE:	19930422
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a1149r.htm
<DESCRIPTION>LYNPARZA SIGNIFICANTLY DELAYED DISEASE PROGRESSION
<TEXT>
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<font style="font-family: Times New Roman; font-size: 13px">INDEX
TO EXHIBITS</font></div>
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<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="font-family: Times New Roman; font-size: 13px">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px">Lynparza
significantly delayed disease progression</font></div>
</div>
</div>
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<font style="font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
26 February 2019 07:00 GMT</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 16px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;significantly delayed disease progression as
1st-line maintenance treatment in germline&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">-mutated metastatic pancreatic
cancer</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Phase III POLO trial met its primary endpoint of progression-free
survival</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
AstraZeneca and MSD's Lynparza is the first PARP inhibitor to
demonstrate</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
benefit in gBRCAm metastatic pancreatic cancer in a Phase III
trial</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck
&amp; Co., Inc. inside the US and Canada) today announced positive
results from the Phase III POLO trial.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Results from the trial showed a statistically-significant and
clinically-meaningful improvement in progression-free survival
(PFS) with&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;(olaparib)&#xA0;vs. placebo. The safety and
tolerability profile of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;was consistent with previous
trials.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
POLO is a randomised, double-blinded, placebo-controlled trial
exploring the efficacy of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">tablets as 1st-line maintenance monotherapy in
patients with germline&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">-mutated (g</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">m) metastatic adenocarcinoma of the pancreas
(pancreatic cancer) whose disease has not progressed on
platinum-based chemotherapy.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Jose&#x301; Baselga, Executive Vice President, Research and
Development, Oncology, said: "This is the first positive Phase III
trial of any PARP inhibitor in germline&#xA0;</font><font style="font-style: italic; color: #000000">BRCA-</font><font style="color: #000000">mutated metastatic pancreatic cancer, a
devastating disease with critical unmet need. The results of POLO
provide further evidence of the clinical benefit
of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;across a variety of&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">-mutated tumour types. We will discuss these
results with global health authorities as soon as
possible."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
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&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">&#xA0;mutations in patients with metastatic
pancreatic cancer."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca and MSD plan to present the full data from the trial at
a forthcoming medical meeting.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About POLO</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
POLO is a Phase III randomised, double-blinded, placebo-controlled,
multicentre trial of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">tablets (300mg twice daily) as maintenance
monotherapy vs. placebo. The trial randomised 154 patients with
g</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">m metastatic pancreatic cancer whose disease had
not progressed on 1st-line platinum-based chemotherapy. Patients
were randomised (3:2) to receive&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;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.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="color: #000000">About&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Lynparza</font><font style="color: #000000">&#xA0;(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&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">1 and/or&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">2. Inhibition of PARP
with&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;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.&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;is
being tested in a range of PARP-dependent tumour types with defects
and dependencies in the DDR.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Lynparza</font><font style="color: #000000">, 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.&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;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.&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;is the foundation of AstraZeneca's
industry-leading portfolio of potential new medicines targeting DDR
mechanisms in cancer cells.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About pancreatic cancer</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Pancreatic cancer is the 12th most common cancer
worldwide,</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;with
466,000 new cases in 2018 alone.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;Germline&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">-mutated
pancreatic cancer accounts for five to seven percent of all cases
globally.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;With
the worst survival rate of the most common
cancers,</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</font><font style="color: #000000">&#xA0;it
is the 4th leading cause of cancer death,</font><font style="font-size: 70%; vertical-align: top; color: #000000">4</font><font style="color: #000000">&#xA0;and
less than seven percent of patients survive more than five years
after diagnosis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</font><font style="color: #000000">&#xA0;Early
diagnosis of pancreatic cancer is difficult, as often there are no
symptoms until it is too late.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font><font style="color: #000000">&#xA0;Around
80% of patients are diagnosed at the metastatic
stage.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font></font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="color: #000000">About&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">&#xA0;mutations</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
BRCA</font><font style="color: #000000">1
and&#xA0;</font><font style="font-style: italic; color: #000000">BRCA</font><font style="color: #000000">2 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.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
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&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About the AstraZeneca and MSD strategic oncology
collaboration</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In July 2017, AstraZeneca and Merck &amp; 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&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">, the world's first PARP inhibitor, and potential
new medicine selumetinib, a MEK inhibitor, for multiple cancer
types. Working together, the companies will
develop&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;and selumetinib in combination with other
potential new medicines and as monotherapies. Independently, the
companies will develop&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;and selumetinib in combination with their
respective PD-L1 and PD-1 medicines.</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About AstraZeneca in Oncology</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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.</font></div>
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&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About AstraZeneca</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
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 &amp;
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide.&#xA0;For more information, please
visit</font><font style="text-decoration: underline; color: #0000FF">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #0000FF">&#xA0;</font><font style="color: #000000">and
follow us on Twitter</font><font style="text-decoration: underline; color: #0000FF">@</font><font style="text-decoration: underline; color: #0000FF">AstraZeneca</font><font style="color: #0000FF">.</font></font></div>
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References</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
1. World Cancer Research Fund International. Pancreatic cancer
statistics. Accessed February 2019 from&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://www.wcrf.org/dietandcancer/cancer-trends/pancreatic-cancer-statistics</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
2. Holter S et al.&#xA0;</font><font style="font-style: italic; color: #000000">Journal of Clinical
Oncology.</font><font style="color: #000000">&#xA0;2015; 33;
3124-3129</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
3. Pancreatic Cancer Action. Facts and statistics. Accessed
February 2019 from&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://pancreaticcanceraction.org/about-pancreatic-cancer/medical-professionals/stats-facts/facts-and-statistics/</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
4. Hidalgo M et al. Addressing the challenges of pancreatic cancer:
future directions for improving outcomes. 2015: Vol 15, Issue 1,
Pg. 8-18</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
5. Pancreatic Cancer UK. Signs and symptoms if pancreatic cancer.
Accessed February 2019 from&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://www.pancreaticcancer.org.uk/information-and-support/facts-about-pancreatic-cancer/signs-and-symptoms-of-pancreatic-cancer/</font></font></div>
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6. Pancreatic Cancer. Some key facts. Accessed February 2019
from&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://www.pancreaticcancer.org.uk/media/409815/mp-pancreatic-cancer-briefing-notes.pdf</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">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.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date:
<font style="font-weight: bold; font-size: 13px">26 February
2019</font></font></div>
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Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Name:
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
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