<SEC-DOCUMENT>0001654954-20-005690.txt : 20200518
<SEC-HEADER>0001654954-20-005690.hdr.sgml : 20200518
<ACCEPTANCE-DATETIME>20200518062507
ACCESSION NUMBER:		0001654954-20-005690
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20200518
FILED AS OF DATE:		20200518
DATE AS OF CHANGE:		20200518

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:		20888011

	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>a1713n.htm
<DESCRIPTION>ENHERTU US BREAKTHROUGH STATUS FOR LUNG CANCER
<TEXT>
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AstraZeneca PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">INDEX
TO EXHIBITS</font></div>
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<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">Enhertu US
Breakthrough status for lung cancer</font></div>
</div>
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&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
18 May 2020 07:00 BST</font></div>
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<font style="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-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; font-style: italic; color: #000000">
Enhertu&#xA0;</font><font style="font-weight: bold; color: #000000">granted&#xA0;Breakthrough
Therapy Designation in the US&#xA0;for</font><font style="color: #000000">&#xA0;</font><font style="font-weight: bold; color: #000000">HER2-mutant metastatic
non-small cell lung 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="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Third Breakthrough Therapy Designation for Enhertu</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">
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi
Sankyo)'s&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;(trastuzumab deruxtecan) has been granted
Breakthrough Therapy Designation (BTD) in the US for the treatment
of patients with metastatic non-small cell lung cancer (NSCLC)
whose tumours have a HER2 mutation and with disease progression on
or after platinum-based therapy.</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">
NSCLC is the most common type of lung cancer, and prognosis is
particularly poor for patients with metastatic disease as only
about 6-10% will be alive five years after
diagnosis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</font><font style="color: #000000">&#xA0;Approximately
2-4% of patients with NSCLC have a HER2
mutation.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3,4</font><font style="color: #FF0000">&#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="color: #000000; font-family: Times New Roman; font-size: 13px">
The Food and Drug Administration (FDA)'s BTD is designed to
accelerate the development and regulatory review of potential new
medicines that are intended to treat a serious condition and
address a significant unmet medical need. The new medicine needs to
have shown encouraging early clinical results that demonstrate
substantial improvement on a clinically significant endpoint over
available medicines.</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, R&amp;D Oncology,
said: "Today's news is very welcome as we continue to evaluate the
potential of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;to help patients with this devastating type
of lung cancer. Targeted treatments and immunotherapies are
demonstrating tremendous advancements, but there remains an unmet
medical need for patients with HER2 mutations who are not
benefiting from such therapies or for those whose cancer continues
to progress."</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">
Gilles Gallant, Senior Vice President, Global Head, Oncology
Development, Oncology R&amp;D, Daiichi Sankyo, said: "We are
encouraged by the promising evidence of activity seen
with&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;in patients with advanced lung cancer and a
HER2 mutation. We look forward to working closely with the FDA on
the potential for&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;to become the first HER2-directed therapy
approved for non-small cell lung 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 FDA granted BTD based on data from the ongoing Phase II
DESTINY-Lung01 trial currently testing&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu,</font><font style="color: #000000">&#xA0;a HER2-directed antibody drug conjugate
(ADC), in patients with HER2-mutant (HER2m) metastatic NSCLC, and
data from the Phase I trial published in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">Cancer
Discovery</font><font style="color: #000000">.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #00B050; 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">
An interim analysis from DESTINY-Lung01 will be presented during
the 2020 American Society of Clinical Oncology ASCO20 Virtual
Scientific Program, 29 to 31 May 2020.</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 overall safety and tolerability profile
of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;in the ongoing DESTINY-Lung01 trial is
consistent with that seen in the Phase I trial. The most common
adverse events to date (n=42) are gastrointestinal and
haematological including nausea, alopecia, anaemia, decreased
appetite and decreased neutrophil count. There have been five cases
of drug-related interstitial lung disease (ILD) and pneumonitis in
patients with HER2m NSCLC, all of which were Grade 2. There have
been no ILD-related deaths.</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">
This&#xA0;is the third&#xA0;BTD granted
for&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;in
the US. Last week,&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;received&#xA0;</font><font style="text-decoration: underline; color: #0000FF">BTD</font><font style="color: #000000">&#xA0;in patients with HER2-positive unresectable
or metastatic gastric or gastroesophageal junction adenocarcinoma
who have received two or more prior regimens including
trastuzumab.&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu&#xA0;</font><font style="color: #000000">received
BTD in 2017 for HER2-positive metastatic breast cancer and
received&#xA0;</font><font style="text-decoration: underline; color: #0000FF">approval</font><font style="color: #000000">&#xA0;in
December 2019.</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">
HER2</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">
HER2 is a tyrosine kinase receptor growth-promoting protein
expressed on the surface of many types of tumours.&#xA0;In some
tumours, HER2 overexpression is associated with a specific HER2
gene alteration known as amplification and is often associated with
aggressive disease and poorer prognosis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</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">
Other HER2 gene alterations (called HER2 mutations) have been
identified in NSCLC, specifically adenocarcinomas, as distinct
molecular targets.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4,7</font><font style="color: #000000">&#xA0;Approximately
2-4% of patients with NSCLC have HER2 mutations, which have been
independently associated with cancer cell growth and poor
prognosis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3,4,7</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">
NSCLC</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">
Lung cancer is the leading cause of cancer death among both men and
women and accounts for about one-fifth of all cancer
deaths.</font><font style="font-size: 70%; vertical-align: top; color: #000000">8</font><font style="color: #000000">&#xA0;In
the US, it is estimated that 228,820 new cases of lung cancer will
be diagnosed in 2020 and more than 135,000 people will die from the
disease.</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-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Lung cancer is broadly split into NSCLC and small cell lung cancer,
with 80-85% classified as NSCLC. Within NSCLC, patients are
classified as squamous, representing 25-30% of patients, or
non-squamous, the most common type representing approximately
70-75% of NSCLC patients. Stage IV is the most advanced form of
lung cancer and is often referred to as metastatic
disease.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10</font><font style="color: #000000">&#xA0;For
these patients with metastatic disease, prognosis is particularly
poor, as only 6-10% will be alive five years after
diagnosis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</font><font style="color: #000000">&#xA0;The
introduction of targeted therapies and checkpoint inhibitors in
recent years has improved outcomes for patients with advanced
NSCLC; however, new approaches are needed for those who are not
eligible for available treatments, or whose cancer continues to
progress.</font><font style="font-size: 70%; vertical-align: top; color: #000000">11</font><font style="color: #000000">&#xA0;Currently,
no medicine is specifically approved for patients with HER2m
NSCLC.</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">
DESTINY-Lung01</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">
DESTINY-Lung01 is a global, Phase II, open-label, multicentre,
two-cohort trial assessing the safety and efficacy
of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;in 170 patients with HER2m (n=90) or
HER2-overexpressing, defined as IHC 3+ or IHC 2+, (n=80)
unresectable and metastatic non-squamous NSCLC whose cancer has
progressed after one or more systemic therapies (including
chemotherapy, molecular targeted therapy or immunotherapy). The
primary endpoint is ORR. Key secondary endpoints include duration
of response, disease control rate, progression-free survival and
overall survival.</font><font style="font-size: 70%; vertical-align: top; color: #000000">12</font></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>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Enhertu</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">
Enhertu</font><font style="color: #000000">&#xA0;(trastuzumab
deruxtecan; fam-trastuzumab deruxtecan-nxki in the US) is a
HER2-directed ADC and is the lead ADC in the oncology portfolio of
Daiichi Sankyo and the most advanced programme in AstraZeneca's ADC
scientific platform. ADCs are targeted cancer medicines that
deliver cytotoxic chemotherapy ("payload") to cancer cells via a
linker attached to a monoclonal antibody that binds to a specific
target expressed on 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-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Enhertu&#xA0;</font><font style="color: #000000">is approved in the
US and Japan for the treatment of adult patients with unresectable
or metastatic HER2-positive breast cancer who have received two or
more prior anti-HER2-based regimens based on the DESTINY-Breast01
trial.</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">Enhertu&#xA0;</font><font style="color: #000000">clinical
development</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">
A comprehensive development programme is underway globally with six
registrational trials evaluating the efficacy and safety
of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;monotherapy across multiple HER2-driven
cancers including breast, gastric and lung cancers. Trials in
combination with other anticancer treatments, such as
immunotherapy, are also underway.</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>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Collaboration between AstraZeneca and Daiichi Sankyo</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 March 2019, AstraZeneca and Daiichi Sankyo entered into a global
collaboration to jointly develop and
commercialise&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;worldwide, except in Japan where Daiichi
Sankyo maintains exclusive rights. Daiichi Sankyo is solely
responsible for manufacturing and supply.</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>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca in lung 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">
AstraZeneca has a comprehensive portfolio of approved and potential
new medicines in late-stage development for the treatment of
different forms of lung cancer spanning different histology,
several stages of disease, lines of therapy and modes of action. We
aim to address the unmet needs of patients with EGFR-mutated
tumours as a genetic driver of disease, which occur in 10-15% of
NSCLC patients in the US and EU and 30-40% of NSCLC patients in
Asia, with the approved medicines&#xA0;</font><font style="font-style: italic; color: #000000">Iressa</font><font style="color: #000000">&#xA0;(gefitinib) and&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;(osimertinib), and its ongoing Phase III
trials ADAURA, LAURA, and FLAURA2.</font><font style="font-size: 70%; vertical-align: top; color: #000000">13-15</font><font style="color: #000000">&#xA0;We
are also committed to addressing tumour mechanisms of resistance
through the ongoing Phase II trials SAVANNAH and ORCHARD which
test&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;in combination with savolitinib, a selective
inhibitor of c-MET receptor tyrosine kinase, along with other
potential new medicines.&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;(trastuzumab&#xA0;deruxtecan), a
HER2-directed ADC is in development for HER2m metastatic
non-squamous NSCLC including trials in combination with other
anticancer medicines.</font><font style="font-size: 70%; vertical-align: top; color: #000000">12</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 extensive late-stage Immuno-Oncology programme focuses on lung
cancer patients without a targetable genetic mutation which
represents up to three-quarters of all patients with lung
cancer.</font><font style="font-size: 70%; vertical-align: top; color: #000000">16</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">,
an anti-PDL1 antibody, is in development for patients with advanced
disease (Phase III trials POSEIDON and PEARL) and for patients in
earlier stages of disease including potentially-curative settings
(Phase III trials AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4,
PACIFIC-5, and ADRIATIC) both as monotherapy and in combination
with tremelimumab and/or chemotherapy.&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is also in development in the Phase II
combination trials NeoCOAST, COAST and HUDSON in combination with
potential new medicines from the early-stage
pipeline.</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca in oncology</font></div>
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<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 six new
medicines launched between 2014 and 2020, and a broad pipeline 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. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investment that
accelerate the delivery of our strategy, as illustrated by the
investment in Acerta Pharma in haematology.</font></div>
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<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">
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and ADCs - 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>
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AstraZeneca</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca&#xA0;(LSE/STO/NYSE: AZN)&#xA0;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
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References</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">1.&#xA0;&#xA0; Goldstraw P, et al. The IASLC Lung
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">5.&#xA0;&#xA0; Tsurutani, J et al. Targeting HER2
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">6.&#xA0;&#xA0; Iqbal N, Iqbal N. Human Epidermal
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">10. American Cancer Society. Lung
Cancer: Non-Small Cell Lung Cancer Stages. Accessed
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">11.&#xA0; Economopoulou P, et al. The emerging
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">12.&#xA0; ClinicalTrials.gov.
NCT03505710. Available at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.clinicaltrials.gov/ct2/show/NCT03505710?term=ds-8201&amp;cond=Nsclc&amp;draw=1&amp;rank=1</font><font style="color: #000000; font-size: 13px">&#xA0;</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">13. Szumera-Cie&#x107;kiewicz A, et al. EGFR
Mutation Testing on Cytological and Histological Samples in
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">14.&#xA0; Keedy VL, et al. American Society of
Clinical Oncology Provisional Clinical Opinion: Epidermal Growth
Factor Receptor (EGFR) Mutation Testing for Patients with Advanced
Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine
Kinase Inhibitor Therapy.&#xA0;</font><font style="font-style: italic; color: #000000">J Clin
Oncol.</font><font style="color: #000000">&#xA0;2011:29;2121-27.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">15.&#xA0; Ellison G, et al. EGFR Mutation Testing
in Lung Cancer: A Review of Available Methods and Their Use for
Analysis of Tumour Tissue and Cytology
Samples.&#xA0;</font><font style="font-style: italic; color: #000000">J Clin
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<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">16.&#xA0; Pakkala, S, et al. Personalized Therapy
for Lung Cancer: Striking a Moving Target.&#xA0;</font><font style="font-style: italic; color: #000000">JCI
Insight.</font><font style="color: #000000">&#xA0;2018;3(15):e120858.</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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SIGNATURES</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Pursuant
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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:
18 May 2020</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
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:
Company Secretary</font></div>
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