<SEC-DOCUMENT>0001654954-21-001754.txt : 20210217
<SEC-HEADER>0001654954-21-001754.hdr.sgml : 20210217
<ACCEPTANCE-DATETIME>20210217063315
ACCESSION NUMBER:		0001654954-21-001754
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20210217
FILED AS OF DATE:		20210217
DATE AS OF CHANGE:		20210217

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		21642590

	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>a3947p.htm
<DESCRIPTION>LYNPARZA: IDMC RECOMMEND EARLY ANALYSIS OF OLYMPIA
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TO EXHIBITS</font></div>
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<font style="font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Lynparza: IDMC recommend early analysis of OlympiA</font></div>
</div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
17 February 2021 07:00 GMT</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>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="color: #000000">IDMC has concluded that OlympiA trial
of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;crossed superiority boundary for
invasive&#xA0;disease-free survival vs. placebo at planned interim
analysis</font></font></div>
<div style="text-align: center; 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">
OlympiA Phase III trial of Lynparza in the adjuvant treatment of
BRCA-mutated high-risk HER2-negative early breast cancer will be
analysed and reported early</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">
The OlympiA Phase III trial for AstraZeneca and
MSD's&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;will move to early primary analysis and
reporting following a recommendation from the Independent Data
Monitoring Committee (IDMC).</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">
Based on the planned interim analysis, the IDMC concluded that the
trial crossed the superiority boundary for its primary endpoint of
invasive disease-free survival (iDFS) and demonstrated a
sustainable, clinically relevant treatment effect
for&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;versus placebo for patients with germline
BRCA-mutated (gBRCAm) high-risk&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">human epidermal growth
factor receptor 2 (</font><font style="color: #000000">HER2)-negative early breast cancer, and recommend
primary analysis now take place.&#xA0;</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">
The OlympiA Phase III trial is a partnership between Breast
International Group (BIG), NRG Oncology, the US National Cancer
Institute (NCI), Frontier Science &amp; Technology Research
Foundation (FSTRF), AstraZeneca and MSD.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;The
trial is sponsored by NRG Oncology in the US and by AstraZeneca
outside the US.</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">
An estimated 2.3 million women were diagnosed with breast cancer
worldwide in 2020, and BRCA mutations are found in approximately 5%
of breast cancer patients.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2-10</font><font style="color: #000000">&#xA0;Around
55-65% of women with a BRCA1 mutation and approximately 45% with a
BRCA2 mutation will develop breast cancer before the age of
70.</font><font style="font-size: 70%; vertical-align: top; color: #000000">11</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FFFFFF; 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">
Andrew Tutt, Global Chair of the OlympiA Phase III trial and
Professor, Institute of Cancer Research and Kings College London,
said: "We are delighted that our global academic and industry
partnership has been able to help investigate a possible
personalised treatment for women with hereditary breast
cancer.&#xA0;The most common cause of hereditary breast cancer is
an inherited mutation in the&#xA0;</font><font style="font-style: italic; color: #000000">BRCA1</font><font style="color: #000000">&#xA0;or&#xA0;</font><font style="font-style: italic; color: #000000">BRCA2</font><font style="color: #000000">&#xA0;genes which also may cause the disease to
develop at a significantly earlier age than is usual.
The&#xA0;OlympiA trial has allowed us to go beyond using genetic
testing to identify patients who are at risk of this disease and
explore the potential of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;to prevent disease recurrence for these
patients. We look forward to analysing and presenting the full
results of the trial at a forthcoming medical
meeting."</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">
Jose&#x301; Baselga, Executive Vice President, Oncology R&amp;D,
said: "Breast cancer remains one of the most common cancers
globally and despite advances in treatment, many patients with
high-risk disease will unfortunately develop a recurrence. We look
forward to reviewing the results."</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: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: " Analysis of the OlympiA trial, based upon the IDMC
recommendation, could represent a potential step forward for
patients with early-stage, high-risk primary breast cancer with a
germline BRCA mutation."</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FFFFFF; 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; background-color: #FFFFFF; font-family: Times New Roman; font-size: 13px">
In its communication, the IDMC did not raise any new safety
concerns. The trial will continue to assess the key secondary
endpoints of overall survival and distant disease-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: 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">
Early breast 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; background-color: #FFFFFF">
Breast cancer is the most common cancer among women worldwide and
an estimated 90% of all breast cancer is diagnosed at an early
stage.</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FFFFFF">12,13</font><font style="font-size: 70%; vertical-align: top; color: #000000">&#xA0;</font><font style="color: #000000">Breast
cancer is one of the most biologically diverse tumour types with
various factors fuelling its development and
progression.</font><font style="font-size: 70%; vertical-align: top; color: #000000">14</font><font style="color: #000000">&#xA0;The
discovery of biomarkers in the development of breast
cancer&#xA0;has greatly impacted scientific understanding of the
disease.</font><font style="font-size: 70%; vertical-align: top; color: #000000">15</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="font-style: italic; color: #000000">BRCA1</font><font style="color: #000000">&#xA0;and&#xA0;</font><font style="font-style: italic; color: #000000">BRCA2</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">
BRCA1</font><font style="color: #000000">&#xA0;and&#xA0;</font><font style="font-style: italic; color: #000000">BRCA2</font><font style="color: #000000">&#xA0;(breast cancer susceptibility genes 1/2) are
human genes that produce proteins responsible for repairing damaged
DNA and play an important role 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&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">and confer sensitivity
to PARP inhibitors including&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Lynparza</font><font style="color: #000000; background-color: #FFFFFF">.</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FFFFFF">16-19</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; color: #000000; font-family: Times New Roman; font-size: 13px">
OlympiA</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">
OlympiA is a Phase III, double-blind, parallel group,
placebo-controlled, multicentre trial testing the efficacy and
safety of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;tablets versus placebo as adjuvant treatment
in patients with gBRCAm high-risk HER2-negative early breast
cancer, who have completed definitive local treatment and
neoadjuvant or adjuvant chemotherapy. The primary endpoint of the
trial is iDFS defined as time from randomisation to date of first
treatment failure that is loco-regional or distant recurrence or
new cancer or death from any cause.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
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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">
NRG 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">
NRG Oncology is a network group funded by the NCI, a part of the
National Institutes of Health. All of the NCI funded network groups
participated in the trial. The NCI and AstraZeneca are
collaborating under a Cooperative Research and Development
Agreement.</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">
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
NRG Oncology brings together the National Surgical Adjuvant Breast
and Bowel Project, the Radiation Therapy Oncology Group, and the
Gynaecologic Oncology Group, with the mission to improve the lives
of cancer patients by conducting practice-changing
multi-institutional clinical and translational
research.</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>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
BIG</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">
The Breast International Group (BIG) is an international
not-for-profit organisation for academic breast cancer research
groups from around the world, based in Brussels,
Belgium.</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">
Founded by leading European opinions leaders in 1999, the
organisation aims to address fragmentation in European breast
cancer research and now represents a network of over 55 like-minded
research groups affiliated with specialised hospitals, research
centres and leading experts across approximately 70 countries on
six continents.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
BIG's research is supported in part by its philanthropy unit, known
as&#xA0;</font><font style="font-style: italic; color: #000000">BIG
against breast cancer</font><font style="color: #000000">, which is
used to interact with the general public and donors, and to raise
funds for BIG's purely academic breast cancer trials and research
programmes.</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">
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<font style="color: #000000; background-color: #FFFFFF; font-weight: bold; font-family: Times New Roman; font-size: 13px">
FSTRF</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; background-color: #FFFFFF">
Frontier Science &amp; Technology Research Foundation (FSTRF) is a
non-profit, research organisation which supports research networks,
pharmaceutical companies and investigators&#xA0;</font><font style="color: #000000">to conduct scientifically meaningful high-quality
clinical trials</font><font style="color: #000000; background-color: #FFFFFF">. The OlympiA trial
involved research staff in the US and in the Affiliate office in
Scotland.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FFFFFF; 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; background-color: #FFFFFF">
FSTRF&#xA0;</font><font style="color: #000000">works with
scientists and technicians in more than 800 laboratories,
universities and medical centres around the world to provide a
comprehensive range of research services throughout the clinical
trial process including design, analysis and
reporting.</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">
Through its work, FSTRF aims to advance the application of
statistical science and practice and data management techniques in
science, healthcare and education.</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-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Lynparza</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 (DDR) in cells/tumours harbouring a
deficiency in homologous recombination repair (HRR), such as
mutations in BRCA1 and/or BRCA2. 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
pathway.</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">&#xA0;is currently
approved in a number of countries, including those in the EU, for
the maintenance treatment of platinum-sensitive relapsed ovarian
cancer. It is approved in the US, the EU, Japan, China, and several
other countries as 1st-line maintenance treatment of BRCA-mutated
advanced ovarian cancer following response to platinum-based
chemotherapy. It is also approved in the US, EU and Japan as a
1st-line maintenance treatment with bevacizumab for patients with
homologous recombination deficient (HRD)-positive advanced ovarian
cancer (BRCAm and/or genomic instability).&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;is approved in the US, Japan, and a number
of other countries for germline BRCA-mutated, HER2-negative,
metastatic breast cancer, previously treated with chemotherapy; in
the EU, this includes locally advanced breast cancer. It is also
approved in the US, the EU, Japan and several other countries for
the treatment of gBRCAm metastatic pancreatic
cancer.&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;is approved in the US for HRR gene-mutated
metastatic castration-resistant prostate cancer (BRCAm and other
HRR gene mutations) and in the EU and Japan for BRCAm metastatic
castration-resistant prostate cancer. Regulatory reviews are
underway in several countries for ovarian, breast, pancreatic and
prostate cancers.</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, has
been used to treat over 40,000 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; 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">
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; background-color: #FFFFFF">
In July 2017, AstraZeneca and Merck &amp; Co., Inc., Kenilworth,
NJ, US, known as MSD outside the US and Canada, announced a global
strategic oncology collaboration to co-develop and
co-commercialise&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Lynparza</font><font style="color: #000000; background-color: #FFFFFF">,
the world's first PARP inhibitor, and&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Koselugo</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;(selumetinib),
a&#xA0;mitogen-activated protein kinase (MEK)&#xA0;inhibitor, for
multiple cancer types. Working together, the companies will
develop&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Lynparza</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;and&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Koselugo</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;in
combination with other potential new medicines and as
monotherapies. Independently, the companies will
develop&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Lynparza</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;and&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Koselugo</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;in
combination with their respective PD-L1 and PD-1
medicines.</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; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca in breast cancer</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">
Driven by a growing understanding of breast cancer biology,
AstraZeneca is starting to challenge, and redefine, the current
clinical paradigm for how breast cancer is classified and treated
to deliver even more effective treatments to patients in need -
with the bold ambition to one day eliminate breast cancer as a
cause of death.</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">
AstraZeneca has a comprehensive portfolio of approved and promising
compounds in development that leverage different mechanisms of
action to address the biologically diverse breast cancer tumour
environment. AstraZeneca aims to continue to transform outcomes for
HR-positive breast cancer with foundational
medicines&#xA0;</font><font style="font-style: italic; color: #000000">Faslodex</font><font style="color: #000000">&#xA0;(fulvestrant) and&#xA0;</font><font style="font-style: italic; color: #000000">Zoladex</font><font style="color: #000000">&#xA0;(goserelin) and the next-generation
selective estrogen receptor degrader (SERD) and potential new
medicine camizestrant (AZD9833). PARP
inhibitor,&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;is a targeted treatment option for
metastatic breast cancer patients with an inherited BRCA mutation.
AstraZeneca with MSD continue to research&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;in metastatic breast cancer patients with an
inherited BRCA mutation and are exploring new opportunities to
treat these patients earlier in their disease
state.</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">
Building on the first approval of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;(trastuzumab deruxtecan), a HER2-directed
antibody-drug conjugate (ADC), in previously treated HER2-positive
metastatic breast cancer, AstraZeneca and Daiichi Sankyo are
exploring its potential in earlier lines of treatment and in new
breast cancer settings. To bring much needed treatment options to
patients with triple-negative breast cancer, an aggressive form of
breast cancer, AstraZeneca is testing
immunotherapy&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;(durvalumab) in combination with other
oncology medicines, including&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;and&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">, assessing the potential of AKT kinase inhibitor,
capivasertib, in combination with chemotherapy, and collaborating
with Daiichi Sankyo to explore the potential of TROP2-directed ADC,
datopotamab deruxtecan.</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
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&#x202F;new medicines that has the
potential to transform patients' lives and the Company's future.
With seven new medicines launched between 2014 and 2020, and a
broad pipeline&#x202F;of small molecules and biologics in
development, the Company is committed to advance oncology as a key
growth driver for AstraZeneca focused on lung, ovarian, breast and
blood cancers.</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">
By harnessing the power of six scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies
- 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">
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 (LSE/STO/Nasdaq: AZN) 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
&amp; Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000">&#xA0;and
follow the Company on Twitter&#xA0;</font><font style="text-decoration: underline; color: #0000FF">@AstraZeneca</font><font style="color: #000000">.</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Contacts</font></div>
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For details on how to contact the Investor Relations Team, please
click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
For Media contacts, click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.</font></font></div>
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References</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; font-size: 13px">
1. ClinicalTrials.gov. Olaparib as Adjuvant Treatment in Patients
with Germline BRCA Mutated High Risk HER2 Negative Primary Breast
Cancer (OlympiA). Available at&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://clinicaltrials.gov/ct2/show/NCT02032823</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">.</font><font style="color: #000000; font-size: 13px">&#xA0;Accessed
February 2021.</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="color: #000000; font-size: 13px">
2. GLOBOCAN. Breast Cancer. Available at&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">.</font><font style="color: #000000; font-size: 13px">&#xA0;Accessed
February 2021.</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="color: #000000">
3. Gomes M.C,&#xA0;</font><font style="font-style: italic; color: #000000">et al</font><font style="color: #000000">. Prevalence of BRCA1 and BRCA2 Mutations in
Breast Cancer Patients from Brazil.&#xA0;</font><font style="font-style: italic; color: #000000">Breast</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000">Cancer Res
Treat</font><font style="color: #000000">. 2007
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
4. Hernandez J.E,&#xA0;</font><font style="font-style: italic; color: #000000">et al</font><font style="color: #000000">. Prevalence of BRCA1 and BRCA2 Mutations in
Unselected Breast Cancer Patients from Medell&#xED;n,
Colombia.&#xA0;</font><font style="font-style: italic; color: #000000">Hered Cancer in Clin
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<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">
5. Bu R,&#xA0;</font><font style="font-style: italic; color: #000000">et al</font><font style="color: #000000">. Identification of Novel BRCA Founder Mutations
in Middle Eastern Breast Cancer Patients Using Capture and Sanger
Sequencing Analysis.&#xA0;</font><font style="font-style: italic; color: #000000">Int J
Cancer</font><font style="color: #000000">.
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
6. Abugattas J,&#xA0;</font><font style="font-style: italic; color: #000000">et al</font><font style="color: #000000">. Prevalence of BRCA1 and BRCA2 Mutations in
Unselected Breast Cancer Patients From
Peru.&#xA0;</font><font style="font-style: italic; color: #000000">Clin Genet</font><font style="color: #000000">. 2015 October;88(4):371-375.</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="color: #000000">
7. Kast K,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;Prevalence of BRCA1/2 Germline Mutations in
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Adrian Kemp</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Company Secretary</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca PLC</font></div>
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SIGNATURES</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">17 February
2021</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
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<font style="font-family: Times New Roman; font-size: 13px">Name:
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<td style="vertical-align: top; width: 85%;">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
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