<SEC-DOCUMENT>0001654954-19-013828.txt : 20191212
<SEC-HEADER>0001654954-19-013828.hdr.sgml : 20191212
<ACCEPTANCE-DATETIME>20191212063058
ACCESSION NUMBER:		0001654954-19-013828
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20191212
FILED AS OF DATE:		20191212
DATE AS OF CHANGE:		20191212

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:		191281007

	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>a6397w.htm
<DESCRIPTION>IMFINZI APPROVED IN CHINA FOR THE TREATMENT OF UNRESECTABLE, STAGE III NON-SMALL CELL LUNG CANCER BASED ON THE PHASE III PACIFIC TRIAL
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AstraZeneca PLC</font></div>
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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="font-weight: bold; font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Imfinzi</font><font style="color: #000000">&#xA0;approved in China
for the treatment of unresectable, Stage III <font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
non-small cell lung cancer based on the Phase III PACIFIC
trial</font></font></font></div>
</div>
</div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;&#xA0;&#xA0; &#xA0;&#xA0;&#xA0; &#xA0;&#xA0;&#xA0;
&#xA0;<br></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
12 December 2019 07:00 GMT</font></div>
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<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">Imfinzi</font><font style="color: #000000">&#xA0;approved in China for the treatment of
unresectable, Stage III</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">
non-small cell lung cancer based on the Phase III PACIFIC
trial</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">
Imfinzi is the only immunotherapy approved in China to treat
patients</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">
in the curative-intent Stage III setting following chemoradiation
treatment</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">
AstraZeneca today announced that it has received marketing
authorisation from China's National Medical Products Administration
(NMPA) for&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;(durvalumab) for the treatment of patients
with unresectable, Stage III non-small cell lung cancer (NSCLC)
whose disease has not progressed following concurrent
platinum-based chemotherapy and radiation therapy
(CRT).</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">The
approval of&#xA0;<font style="font-style: italic">Imfinzi</font>&#xA0;is based on results from
the&#xA0;<font style="text-decoration: underline; color: #0000FF">primary
analysis</font>&#xA0;of progression-free survival (PFS) and
supported by&#xA0;<font style="text-decoration: underline; color: #0000FF">overall survival
(OS)</font><font style="text-decoration: underline; color: #0000FF">&#xA0;</font>from the
Phase III PACIFIC trial, both published in&#xA0;<font style="font-style: italic; color: #000000">The New England Journal of
Medicine</font>. A post-hoc analysis of&#xA0;<font style="text-decoration: underline; color: #0000FF">three-year
OS</font>&#xA0;results has since shown that consistent efficacy was
maintained for treatment with&#xA0;<font style="font-style: italic">Imfinzi</font>&#xA0;after additional follow
up.<font style="font-size: 70%; vertical-align: top">1</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">Dave
Fredrickson, Executive Vice President, Oncology Business Unit
said:&#xA0;<font style="color: #000000">"</font>This approval
illustrates our long-standing commitment to improving health
outcomes in China, where more than one-third of the world's lung
cancer&#xA0;diagnoses&#xA0;and deaths occur. As the global standard
of care in this curative-intent setting,&#xA0;<font style="font-style: italic">Imfinzi</font>&#xA0;is an important new option
for patients in China."</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">Results
demonstrated a statistically significant and clinically meaningful
OS and PFS benefit for treatment with&#xA0;<font style="font-style: italic">Imfinzi</font>&#xA0;vs. placebo after
concurrent CRT.&#xA0;<font style="font-style: italic">Imfinzi</font>&#xA0;reduced the risk of death
by 32% (equal to a hazard ratio of 0.68) and prolonged the time
patients lived without disease progression or death by more than 11
months (median PFS: 16.8 vs. 5.6 months; hazard ratio of
0.52).</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-weight: bold; font-family: Times New Roman; font-size: 13px">
Phase III PACIFIC trial primary endpoints</font></div>
<div>
<table cellpadding="0" cellspacing="0" style="width: 100%; font-family: Times New Roman; font-size: 13px">
<tr>
<td style="vertical-align: middle; width: 37%; border-left: 0.5pt solid #000000; border-top: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: middle; width: 32%; border-left: 0.5pt solid #000000; border-top: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Imfinzi</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">
(n=476)</font></div>
</td>
<td colspan="2" style="vertical-align: middle; width: 32%; border-left: 0.5pt solid #000000; border-right: 0.5pt solid #000000; border-top: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<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">
Placebo</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">
(n=237)</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 37%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<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">
OS (primary endpoint)<font style="font-size: 70%; vertical-align: top">i</font></font></div>
</td>
<td colspan="3" style="vertical-align: middle; width: 63%; border-left: 0.5pt solid #000000; border-right: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 37%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Number
of deaths (%)</font></div>
</td>
<td style="vertical-align: middle; width: 32%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">183
(38.4%)</font></div>
</td>
<td colspan="2" style="vertical-align: middle; width: 32%; border-left: 0.5pt solid #000000; border-right: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">116
(48.9%)</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 37%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Hazard
ratio (95% CI)<font style="font-size: 70%; vertical-align: top">ii</font></font></div>
</td>
<td colspan="3" style="vertical-align: middle; width: 63%; border-left: 0.5pt solid #000000; border-right: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0.68
(0.53, 0.87)</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 37%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">p-value<font style="font-size: 70%; vertical-align: top">ii,iii</font></font></div>
</td>
<td colspan="3" style="vertical-align: middle; width: 63%; border-left: 0.5pt solid #000000; border-right: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0.0025</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 37%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Median
in months (95% CI)</font></div>
</td>
<td style="vertical-align: middle; width: 32%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">NR<font style="font-size: 70%; vertical-align: top">4</font></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">(34.7,
NR)<font style="font-size: 70%; vertical-align: top">iv</font></font></div>
</td>
<td colspan="2" style="vertical-align: middle; width: 32%; border-left: 0.5pt solid #000000; border-right: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">28.7</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">(22.9,
NR)<font style="font-size: 70%; vertical-align: top">iv</font></font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 37%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<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-weight: bold">
PFS (primary endpoint)</font><font style="font-size: 70%; vertical-align: top">v</font></font></div>
</td>
<td colspan="3" style="vertical-align: middle; width: 63%; border-left: 0.5pt solid #000000; border-right: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 37%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Number
of events (%)</font></div>
</td>
<td style="vertical-align: middle; width: 32%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">214
(45%)</font></div>
</td>
<td colspan="2" style="vertical-align: middle; width: 32%; border-left: 0.5pt solid #000000; border-right: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">157
(66%)</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 37%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Hazard
ratio (95% CI)<font style="font-size: 70%; vertical-align: top">ii,vi</font></font></div>
</td>
<td colspan="3" style="vertical-align: middle; width: 63%; border-left: 0.5pt solid #000000; border-right: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0.52
(0.42, 0.65)</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 37%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">p-value<font style="font-size: 70%; vertical-align: top">ii,vii</font></font></div>
</td>
<td colspan="3" style="vertical-align: middle; width: 63%; border-left: 0.5pt solid #000000; border-right: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&lt;0.0001</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 37%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Median
in months (95% CI)</font></div>
</td>
<td style="vertical-align: middle; width: 32%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">16.8</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">(13.0,
18.1)</font></div>
</td>
<td colspan="2" style="vertical-align: middle; width: 32%; border-left: 0.5pt solid #000000; border-right: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">5.6</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">(4.6,
7.8)</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 37%; border-left: 1pt solid #000000; border-bottom: 2px solid #000000">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: middle; width: 32%; border-bottom: 2px solid #000000">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: middle; width: 0%; border-bottom: 2px solid #000000">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: middle; width: 31%; border-right: 1pt solid #000000; border-bottom: 2px solid #000000">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</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"><font style="font-size: 70%; vertical-align: top; color: #000000">
i</font><font style="color: #000000">OS results are based on the
interim OS analysis with a data cut-off date of 22 March
2018.</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-size: 70%; vertical-align: top; color: #000000">
ii</font><font style="color: #000000">Stratified by sex, age, and
smoking history.</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-size: 70%; vertical-align: top; color: #000000">
iii</font><font style="color: #000000">Criteria for statistical
significance at the interim analysis of OS was a
p-value&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#x2264;</font><font style="color: #000000">&#xA0;0.00274
(using Lan DeMets spending function approximating O'Brien Fleming
boundary).</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-size: 70%; vertical-align: top; color: #000000">
iv</font><font style="color: #000000">Not reached
(NR).</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-size: 70%; vertical-align: top; color: #000000">
v</font><font style="color: #000000">Assessed by blinded
independent central review (BICR) according to RECIST
v1.1.</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-size: 70%; vertical-align: top; color: #000000">
vi</font><font style="color: #000000">PFS results are based on the
interim PFS analysis with a data cut-off date of 13 February
2017.</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-size: 70%; vertical-align: top; color: #000000">
vii</font><font style="color: #000000">Criteria for statistical
significance at the interim analysis of PFS was a
p-value&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#x2264;</font><font style="color: #000000">&#xA0;0.011035
(using Lan DeMets spending function approximating O'Brien Fleming
boundary).</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>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Among
patients treated with&#xA0;<font style="font-style: italic">Imfinzi</font>, the most common adverse
reactions (greater than or equal to 20% of patients) were cough,
fatigue, pneumonitis or radiation pneumonitis, upper respiratory
tract infections, dyspnoea, and rash. Serious adverse reactions
occurred in 29% of patients treated with&#xA0;<font style="font-style: italic">Imfinzi</font>, and 15% of patients
discontinued treatment due to adverse reactions.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-style: italic; 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">
Imfinzi&#xA0;</font>is approved in the curative-intent setting of
unresectable, Stage III NSCLC after CRT in 54 countries and
regions, including the US, Japan and across the EU, based on the
Phase III PACIFIC trial.&#xA0;<font style="color: #000000">The
PACIFIC regimen, CRT followed by&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">, is the global standard of care for the treatment
of unresectable Stage III NSCLC.</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-weight: bold; font-family: Times New Roman; font-size: 13px">
About PACIFIC</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">The
PACIFIC trial was a Phase III, randomised, double-blinded,
placebo-controlled, multi-centre trial of&#xA0;<font style="font-style: italic">Imfinzi</font>&#xA0;as treatment in
'all-comer' patients (i.e. regardless of PD-L1 status) with
unresectable, Stage III (locally advanced) NSCLC whose disease had
not progressed following concurrent platinum-based
CRT.</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">The
trial was conducted at 235 centres across 26 countries involving
713 patients. The primary endpoints of the trial were PFS and OS,
and secondary endpoints included landmark PFS and OS, objective
response rate, and duration of response.</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About Stage III 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">
Stage III (locally advanced) NSCLC is commonly divided into three
sub-categories (IIIA, IIIB and IIIC), defined by how much the
cancer has spread locally and the possibility of
surgery.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;Stage
III disease is different from Stage IV disease, when the cancer has
spread throughout the body (metastasised), as the majority of Stage
III patients are currently treated with curative
intent.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,3</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">
Stage III NSCLC represents approximately one-third of NSCLC
incidence and in 2015 was estimated to affect nearly 200,000
patients in the following eight key countries: China, France,
Germany, Italy, Japan, Spain, UK, US.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4,5</font><font style="color: #000000">&#xA0;The
majority of Stage III NSCLC patients are diagnosed with
unresectable tumours.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font><font style="color: #000000">&#xA0;Prior
to approval of&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;in this setting</font>, no new treatments
beyond CRT had been available to patients for decades.<font style="font-size: 70%; vertical-align: top">7-10</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-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="color: #000000">About&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</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">
Imfinzi</font><font style="color: #000000">&#xA0;(durvalumab) is a
human monoclonal antibody that binds to PD-L1 and blocks the
interaction of PD-L1 with PD-1 and CD80, countering the tumour's
immune-evading tactics and releasing the inhibition of immune
responses.</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">
Imfinzi</font><font style="color: #000000">&#xA0;is also approved
for previously treated patients with advanced bladder cancer in 11
countries, including 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">
As part of a broad development programme,&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is also being tested as a monotherapy and in
combination with tremelimumab, an anti-CTLA4 monoclonal antibody
and potential new medicine, as a treatment for patients with NSCLC,
small cell lung cancer, bladder cancer, head and neck cancer, liver
cancer, biliary tract cancer, cervical cancer and other solid
tumours.</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About 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 clinical development for the treatment
of different forms of lung cancer spanning 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 our 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 ongoing Phase III trials
ADAURA, LAURA, and FLAURA2 as well as the Phase II combination
trials SAVANNAH and ORCHARD.</font><font style="font-size: 70%; vertical-align: top; color: #000000">11-13</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">
Our extensive late-stage Immuno-Oncology programme focuses on lung
cancer patients without a targetable genetic mutation which
represents approximately three-quarters of all patients with lung
cancer.</font><font style="font-size: 70%; vertical-align: top; color: #000000">14</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, PEARL, and CASPIAN) 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.</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">
About AstraZeneca's approach to Immuno-Oncology (IO)</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">
Immuno-oncology (IO) is a therapeutic approach designed to
stimulate the body's immune system to attack tumours. The Company's
IO portfolio is anchored by immunotherapies that have been designed
to overcome anti-tumour immune suppression. AstraZeneca believes
that IO-based therapies offer the potential for life-changing
cancer treatments for the clear majority of patients.</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 Company is pursuing a comprehensive clinical-trial programme
that includes&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;as a monotherapy and in combination with
tremelimumab in multiple tumour types, stages of disease, and lines
of therapy, using the PD-L1 biomarker as a decision-making tool to
define the best potential treatment path for a patient. In
addition, the ability to combine our IO portfolio with radiation,
chemotherapy, small targeted molecules from across AstraZeneca's
Oncology pipeline, and from research partners, may provide new
treatment options across a broad range of
tumours.</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About AstraZeneca in Oncology</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With at
least six new medicines to be launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in development, 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 investments that
accelerate the delivery of our strategy, as illustrated by the
investment in Acerta Pharma in haematology.</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 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="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About 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&#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 and Metabolism, and Respiratory.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide.&#xA0;Please
visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000">&#xA0;and
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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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Company Secretary</font></div>
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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
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<font style="font-family: Times New Roman; font-size: 13px">Date:
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
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