<SEC-DOCUMENT>0001654954-20-010257.txt : 20200921
<SEC-HEADER>0001654954-20-010257.hdr.sgml : 20200921
<ACCEPTANCE-DATETIME>20200921065544
ACCESSION NUMBER:		0001654954-20-010257
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20200921
FILED AS OF DATE:		20200921
DATE AS OF CHANGE:		20200921

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:		201185155

	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>a5530z.htm
<DESCRIPTION>LYNPARZARECOMMENDED FOR APPROVAL IN EU BY CHMP AS 1ST-LINE MAINTENANCE TREATMENT WITH BEVACIZUMAB FOR HRD-POSITIVE ADVANCED OVARIAN CANCER
<TEXT>
<html>
<head>
<!-- Document created using Blueprint(R) - powered by Issuer Direct - www.issuerdirect.com -->
<!-- Copyright 2020 Issuer Direct Corporation -->
<title>a5530z</title>
</head>
<body style="font-family: Times New Roman; font-size: 13px;">
<div id="pgbrk" style="width: 100%; margin-left: 0px; text-indent: 0px; margin-right: 0px">
<div id="hdr">
<div style="text-align: left; width: 100%; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</div>
</div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
FORM 6-K</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">SECURITIES
AND EXCHANGE COMMISSION</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Washington,
D.C. 20549</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>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Report
of Foreign Issuer</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Pursuant
to Rule 13a-16 or 15d-16 of</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">the
Securities Exchange Act of 1934</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>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">For the
month of September 2020</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>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Commission
File Number: 001-11960</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>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
AstraZeneca PLC</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>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">1
Francis Crick Avenue</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Cambridge
Biomedical Campus</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Cambridge
CB2 0AA</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">United
Kingdom</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>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Form
20-F X Form 40-F __</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Yes __
No X</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">If
&#x201C;Yes&#x201D; is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#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>
<div><font style="font-family: Times New Roman; font-size: 10">&#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>
<div><font style="font-family: Times New Roman; font-size: 10">&#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>
<div><font style="font-family: Times New Roman; font-size: 10">&#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>
<div><font style="font-family: Times New Roman; font-size: 10">&#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>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
AstraZeneca PLC</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>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">INDEX
TO EXHIBITS</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>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: justify; display: table-cell"><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;recommended for
approval in EU by CHMP as 1st-line maintenance treatment with
bevacizumab for HRD-positive advanced ovarian
cancer</font></font></div>
</div>
</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>
<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">
21 September 2020 07:00 BST</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-family: Times New Roman; font-size: 13px">
<font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;recommended for approval in EU by CHMP as
1st-line maintenance treatment with bevacizumab for HRD-positive
advanced ovarian 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">
Patients treated with Lynparza and bevacizumab lived without
disease</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">
progression for a median of 37.2 months vs. 17.7 months for
bevacizumab alone</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">
&#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">
One in two women with advanced ovarian cancer has an HRD-positive
tumour</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 and MSD's&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;(olaparib) has been recommended for
marketing authorisation in the European Union (EU) for the 1st-line
maintenance treatment with bevacizumab of patients with homologous
recombination deficient (HRD)-positive advanced ovarian
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="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion on a biomarker
subgroup analysis of the</font><font style="text-decoration: underline; color: #0000FF">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">PAOLA-1
Phase III trial</font><font style="color: #000000">, which was
published in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
New England Journal of Medicine</font><font style="font-style: italic; color: #000000">.</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 trial showed that&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;in combination with bevacizumab maintenance
treatment reduced the risk of disease progression or death by 67%
(based on a hazard ratio of 0.33; 95% confidence interval
0.25-0.45). The addition of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;improved progression-free survival (PFS) to
a median of 37.2 months versus 17.7 months with bevacizumab alone
in patients with HRD-positive advanced ovarian
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="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
For patients with advanced ovarian cancer, the primary aim of
1st-line treatment is to delay disease progression for as long as
possible with the intent to achieve long-term
remission.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1-3</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">
Ovarian cancer is the fifth most common cause of cancer death in
Europe and the five-year survival rate is approximately 45%, due in
part because women are often diagnosed with advanced disease (Stage
III or IV).</font><font style="font-size: 70%; vertical-align: top; color: #000000">4,5</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">
Jos&#xE9; Baselga, Executive Vice President, Oncology R&amp;D,
said: "Half of all newly diagnosed patients with advanced ovarian
cancer have HRD-positive tumours.&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;together with bevacizumab has demonstrated a
median progression-free survival benefit of more than three years,
offering new hope for women in this setting. This recommendation is
a vital step toward addressing a significant unmet need and could
bring a new treatment option that delays relapse in this
devastating disease."</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">
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "HRD is an important biomarker of advanced ovarian cancer
that can inform how physicians in the EU treat this aggressive type
of cancer.&#xA0;This recommendation and the results from the
PAOLA-1 trial underscore the importance of HRD testing at diagnosis
to determine the best course of treatment for women with advanced
ovarian 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">
&#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 CHMP recommendation is for&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;in combination with bevacizumab for the
maintenance treatment of adult patients with advanced (FIGO stages
III and IV) high-grade epithelial ovarian, fallopian tube or
primary peritoneal cancer who are in response (complete or partial)
following completion of 1st-line platinum-based chemotherapy in
combination with bevacizumab and whose cancer is associated with
HRD positive status defined by either a breast cancer
susceptibility gene 1/2 (BRCA1/2) mutation and/or genomic
instability.</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">&#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">
Further results from the PAOLA-1 trial&#xA0;recently presented
during the 2020 European Society for Medical Oncology virtual
congress showed that&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;in combination with bevacizumab maintenance
treatment demonstrated a statistically significant improvement in
the time to second disease progression (PFS2) versus bevacizumab
alone in patients with HRD-positive advanced ovarian cancer, a key
secondary endpoint. The results showed&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;with bevacizumab provided benefit beyond
first disease progression, improving PFS2 to a median of 50.3
months versus 35.3 months with bevacizumab
alone.</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;in combination
with bevacizumab is&#xA0;</font><font style="text-decoration: underline; color: #0000FF">approved in the
US</font><font style="color: #000000">&#xA0;and several other
countries as a 1st-line maintenance treatment for patients with
HRD-positive advanced ovarian cancer and is currently under
regulatory review in other countries around the
world.</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">
Ovarian 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">
In 2018, there were nearly 68,000 new cases of ovarian cancer
diagnosed in Europe and around 45,000 deaths.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4</font><font style="color: #000000">&#xA0;Approximately
50% of ovarian cancers are HRD-positive including BRCA1/2
mutation.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6,7&#xA0;</font><font style="color: #000000">Approximately
22% of ovarian cancers have a BRCA1/2 mutation.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6-8</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">
Homologous recombination deficiency</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">
HRD, which defines a subgroup of ovarian cancer, encompasses a wide
range of genetic abnormalities, including BRCA mutations and
beyond. As with BRCA gene mutations, HRD interferes with normal
cell DNA repair mechanisms and confers sensitivity to PARP
inhibitors including&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9</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">
PAOLA-1</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">
PAOLA-1 is a double-blind Phase III trial testing the efficacy and
safety of&#x202F;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#x202F;added to standard-of-care bevacizumab
versus bevacizumab alone, as a 1st-line maintenance treatment for
newly diagnosed advanced FIGO Stage III-IV high-grade serous or
endometroid ovarian, fallopian tube, or peritoneal cancer patients
who had a complete or partial response to 1st-line treatment with
platinum-based chemotherapy and bevacizumab.&#xA0;AstraZeneca and
MSD&#xA0;</font><font style="text-decoration: underline; color: #0000FF">announced in August
2019</font><font style="color: #000000">&#xA0;that the trial met
its primary endpoint of PFS in the overall trial
population.</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; 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 as a 1st-line
maintenance treatment with bevacizumab for patients with
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 and several other countries for the treatment of
germline BRCAm 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
mCRPC (BRCAm and other HRR gene mutations). 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">&#xA0;which is being
jointly developed and commercialised by AstraZeneca and MSD, has
been used to treat over 30,000 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="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">
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">Lynparza</font><font style="color: #000000">, the world's first PARP inhibitor,
and&#xA0;</font><font style="font-style: italic; color: #000000">Koselugo</font><font style="color: #000000">&#xA0;(selumetinib), a mitogen-activated protein
kinase (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&#xA0;</font><font style="font-style: italic; color: #000000">Koselugo</font><font style="color: #000000">&#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">Lynparza</font><font style="color: #000000">&#xA0;and&#xA0;</font><font style="font-style: italic; color: #000000">Koselugo</font><font style="color: #000000">&#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 oncology</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 deep-rooted heritage in oncology and offers a
quickly growing portfolio of</font><font style="font-weight: bold; color: #000000">&#xA0;</font><font style="color: #000000">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</font><font style="font-weight: bold; color: #000000">&#xA0;</font><font style="color: #000000">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></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="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>
<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</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/NYSE: 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">@</font><font style="text-decoration: underline; color: #0000FF">AstraZeneca</font><font style="color: #000000">.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #0000FF; 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">
Contacts</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">
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>
<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">
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">
1. Raja et al. (2012). Optimal first-line treatment in ovarian
cancer.&#xA0;</font><font style="font-style: italic; color: #000000">Annals on
Oncology</font><font style="color: #000000">. 23 Suppl 10,
x118-127.</font><font style="font-weight: bold; color: #000000">&#xA0;</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. NHS Choices, Ovarian Cancer Available
at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.nhs.uk/conditions/ovarian-cancer/treatment/</font><font style="color: #000000; font-size: 13px">&#xA0;[Accessed&#xA0;September&#xA0;2020].</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. Ledermann et al. (2013). Newly diagnosed and relapsed epithelial
ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis,
treatment and follow-up.&#xA0;</font><font style="font-style: italic; color: #000000">Annals of
Oncology</font><font style="color: #000000">, 24,
pp.vi24-vi32.</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">
4. The World Health Organization. IARC. Globocan. (2018). Available
at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">http://gco.iarc.fr/</font><font style="color: #000000; font-size: 13px">&#xA0;[Accessed
September 2020].</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">
5. EuroHealth. (2018). Ovarian Cancer: The Silent Killer. Available
at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://eurohealth.ie/policy-brief-women-and-ovarian-cancer-in-the-eu-2018/</font><font style="color: #000000; font-size: 13px">&#xA0;[Accessed&#xA0;September&#xA0;2020].</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">
6. Moschetta et al. (2016). BRCA somatic mutations and epigenetic
BRCA modifications in serous ovarian
cancer.&#xA0;</font><font style="font-style: italic; color: #000000">Annals of
Oncology</font><font style="color: #000000">, 27(8),
pp.1449-1455.</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. Bonadio et al. (2018). Homologous recombination deficiency in
ovarian cancer: a review of its epidemiology and
management.&#xA0;</font><font style="font-style: italic; color: #000000">Clinics</font><font style="color: #000000">, 73(Suppl 1): e450s.</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">
8. Pothuri. (2013). BRCA1- and BRCA2-related mutations: therapeutic
implications in ovarian cancer.&#xA0;</font><font style="font-style: italic; color: #000000">Annals of
Oncology</font><font style="color: #000000">,
24.</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">
9. Moore, K. (2018). Maintenance Olaparib in Patients with Newly
Diagnosed Advanced Ovarian Cancer.&#xA0;</font><font style="font-style: italic; color: #000000">New England Journal of
Medicine</font><font style="color: #000000">, 379(26),
pp.2495-2505.</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">
Adrian Kemp</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">
Company Secretary</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 PLC</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">
&#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>
<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>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-style: italic; 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="text-decoration: underline; font-family: Times New Roman; font-size: 13px">
SIGNATURES</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</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">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>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div>
<table cellpadding="0" cellspacing="0" style="width: 100%; font-family: Times New Roman; font-size: 13px">
<tr>
<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</font></div>
</td>
</tr></table>
</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>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</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">Date:
<font style="font-weight: bold; font-size: 13px">21
Septemb</font><font style="font-weight: bold; font-size: 13px">er
2020</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div>
<table cellpadding="0" cellspacing="0" style="width: 100%; font-family: Times New Roman; font-size: 13px">
<tr>
<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Adrian Kemp</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Name:
Adrian Kemp</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
</td>
</tr></table>
</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>
<div><font style="font-family: Times New Roman; font-size: 10">&#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>
<div><font style="font-family: Times New Roman; font-size: 10">&#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>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div id="pgbrk" style="width: 100%; margin-left: 0px; text-indent: 0px; margin-right: 0px">
<div id="ftr">
<div style="text-align: left; width: 100%; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</div>
<div id="pb" style="text-align: center; margin-left: 0px; margin-right: 0px; margin-bottom: 6px; width: 100%; height: 1px; background-color: rgb(255, 255, 255);">
<!--page break--></div>
</div>
</body>
</html>
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
