<SEC-DOCUMENT>0001654954-18-008125.txt : 20180727
<SEC-HEADER>0001654954-18-008125.hdr.sgml : 20180727
<ACCEPTANCE-DATETIME>20180727113934
ACCESSION NUMBER:		0001654954-18-008125
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20180727
FILED AS OF DATE:		20180727
DATE AS OF CHANGE:		20180727

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:		18973911

	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>a0432w.htm
<DESCRIPTION>CHMP RECOMMENDS IMFINZI FOR STAGE III NSCLC
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AstraZeneca PLC</font></div>
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AstraZeneca PLC</font></div>
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TO EXHIBITS</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 13px">
1. CHMP recommends Imfnizi for Stage III nsclc</font><font style="font-style: italic; color: #000000; font-family: Times New Roman">&#xA0;</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
This announcement contains inside information</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">
27 July 2018 14:00 BST</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 16px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="font-style: italic">Imfinzi</font> receives positive
EU CHMP opinion for locally-</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">
advanced, unresectable non-small cell lung cancer</font></div>
<div style="text-align: justify; 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">
&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Recommended marketing authorisation for 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; font-family: Times New Roman; font-size: 13px">
whose tumours express PD-L1 on &#x2265;1% of tumour
cells</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: 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 is the first immunotherapy recommended for
approval</font></div>
<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">
for the treatment of locally-advanced, unresectable
NSCLC</font></div>
<div style="text-align: justify; 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">
&#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">AstraZeneca
and MedImmune, its global biologics research and development arm,
today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency has adopted a positive
opinion, recommending a marketing authorisation
of&#xA0;<font style="font-style: italic">Imfinzi</font>&#xA0;(durvalumab)
for the treatment of locally-advanced, unresectable non-small cell
lung cancer (NSCLC) in adults whose tumours express PD-L1 on
&#x2265;1% of tumour cells and whose disease has not progressed
following platinum-based chemotherapy and radiation therapy (CRT).
The recommendation is based on the progression-free survival (PFS)
and overall survival (OS) primary endpoints of the Phase III
PACIFIC trial, and post-hoc subgroup analyses by PD-L1 expression
requested by the CHMP.</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">Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said:&#xA0;"The CHMP positive
opinion brings European patients closer to having a treatment
following chemoradiation therapy. There have been no new treatments
in this setting for decades. With approximately a third of European
non-small cell lung cancer patients presenting with this stage of
disease, we are excited by this potential new standard of care in
this curative-intent setting."</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">In the
PACIFIC trial, <font style="font-style: italic">Imfinzi</font>
demonstrated a statistically-significant and clinically-meaningful
improvement in PFS and OS in "all-comer" patients. The recommended
label reflects most of the patients in the trial with a known PD-L1
status.</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">Overall
survival results from the PACIFIC trial will be presented at a
forthcoming medical meeting.</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
positive opinion from the CHMP will now be reviewed by the European
Commission, which has the authority to approve medicines for the 28
European Union member countries plus Iceland, Norway and
Liechtenstein. Earlier this year,&#xA0;<font style="font-style: italic">Imfinzi</font>&#xA0;was approved for
unresectable, Stage III NSCLC in the US, Canada, Switzerland,
India, Japan and Brazil based on the Phase III PACIFIC trial. In
addition to the EU,&#xA0;other global health authority reviews and
submissions are ongoing.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; 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">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. Stage III
disease is different from Stage IV disease, when the cancer has
spread (metastasised) to distant organs, as Stage III is currently
treated with curative intent.</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">Stage
III NSCLC represents approximately one-third of NSCLC incidence and
was estimated to affect around 105,000 patients in the top-eight
countries (China, France, Germany, Italy, Japan, Spain, UK, US) in
2017. The majority of Stage III NSCLC patients are diagnosed with
unresectable tumours. No new treatments beyond chemoradiation
therapy, followed by active surveillance to monitor for
progression, have been available to patients for
decades.</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 is a randomised, double-blinded, placebo-controlled,
multi-centre trial of <font style="font-style: italic">Imfinzi</font> as treatment in 'all-comer'
patients (i.e. regardless of PD-L1 status) with unresectable, Stage
III NSCLC whose disease has not progressed following platinum-based
chemotherapy and radiation therapy (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 is being conducted in 235 centres across 26 countries
involving 713 patients. The primary endpoints of the trial are PFS
and OS, and secondary endpoints include 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-weight: bold; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
About <font style="font-style: italic">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">
Imfinzi</font> (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></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="font-style: italic">
Imfinzi</font> is approved for unresectable, Stage III NSCLC in the
US, Canada, Switzerland, India, and Japan 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-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">As part
of a broad development programme, <font style="font-style: italic">Imfinzi</font> is also being tested as a
monotherapy and in combination with chemotherapy, radiation
therapy, small molecules, and tremelimumab, an anti-CTLA4
monoclonal antibody, as a first or second-line treatment for
patients with NSCLC, small cell lung cancer, locally-advanced or
metastatic urothelial carcinoma, head and neck cancer and other
solid tumours.</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 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">Lung
cancer is the leading cause of cancer death among both men and
women, accounting for about one-third of all cancer
deaths.</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">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 across all stages of disease and
lines of therapy. 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 <font style="font-style: italic">Iressa</font> and <font style="font-style: italic">Tagrisso</font> and ongoing FLAURA, ADAURA and
LAURA Phase III trials. Our extensive late-stage immuno-oncology
programme focuses on 75-80% of patients with lung cancer without a
known genetic mutation. The portfolio includes <font style="font-style: italic">Imfinzi</font>, an anti-PDL1 antibody, which
is in development as monotherapy (ADJUVANT BR.31, PACIFIC2, MYSTIC
and PEARL Phase III trials) and in combination with tremelimumab
and/or chemotherapy (MYSTIC, NEPTUNE, POSEIDON and CASPIAN Phase
III trials).</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 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="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. At AstraZeneca and MedImmune, our
biologics research and development arm, our IO portfolio is
anchored by immunotherapies that have been designed to overcome
anti-tumour immune suppression. We believe that IO-based therapies
will 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="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">We are
pursuing a comprehensive clinical trial programme that includes
<font style="font-style: italic">Imfinzi</font> (anti-PDL1) as
monotherapy and in combination with tremelimumab (anti-CTLA4) 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 small, targeted molecules
from across our Oncology pipeline, and with those of our research
partners, may provide new treatment options across a broad range of
tumours.</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 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">AstraZeneca
has a deep-rooted heritage in Oncology and offers a quickly-growing
portfolio of new medicines that has the potential to transform
patients' lives and the Company's future. With at least six new
medicines to be launched between 2014 and 2020, and a broad
pipeline of small molecules and biologics in development, we are
committed to advancing Oncology as a growth driver for AstraZeneca,
focused on lung, ovarian, breast and blood cancers. In addition to
our core capabilities, we actively pursue innovative partnerships
and investments that accelerate the delivery of our strategy as
illustrated by our investment in Acerta Pharma in
haematology.</font></div>
<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">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; 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 MedImmune</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">MedImmune
is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
small-molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology; Respiratory; Cardiovascular, Renal &amp; Metabolic
Diseases; and Infection and Vaccines. The MedImmune headquarters is
located in Gaithersburg, MD, one of AstraZeneca's three global
R&amp;D centres, with additional sites in Cambridge, UK, and
Mountain View, CA. For more information, please visit <font style="text-decoration: underline; color: #0000FF">www.medimmune.com</font>.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; 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="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &amp;
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide.</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
For more information, please visit</font> <font style="text-decoration: underline; color: #0000FF">www.astrazeneca.com</font>
<font style="color: #000000">and follow us on Twitter
@AstraZeneca.</font></font></div>
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Meixell</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">US</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">Date:
<font style="font-weight: bold; font-size: 13px">27 July
2018</font></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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