<SEC-DOCUMENT>0001654954-19-011810.txt : 20191017
<SEC-HEADER>0001654954-19-011810.hdr.sgml : 20191017
<ACCEPTANCE-DATETIME>20191017065052
ACCESSION NUMBER:		0001654954-19-011810
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20191017
FILED AS OF DATE:		20191017
DATE AS OF CHANGE:		20191017

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:		191154003

	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>a1966q.htm
<DESCRIPTION>TRASTUZUMAB DERUXTECAN GRANTED FDA PRIORITY REVIEW FOR TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER
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<font style="font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Trastuzumab deruxtecan granted FDA Priority Review for</font>
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
treatment of patients with HER2-positive metastatic breast
cancer</font></div>
</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">
17 Oct 2019 07:00 BST</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 16px">
&#xA0;</font></div>
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<font style="color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Trastuzumab deruxtecan granted FDA Priority Review for</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">
treatment of patients with HER2-positive metastatic breast
cancer</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#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">
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)
today announced that the US Food and Drug Administration (FDA) has
accepted for review the Biologics License Application (BLA) for
[fam-] trastuzumab deruxtecan (DS-8201) and granted Priority
Review.</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 Prescription Drug User Fee Act (PDUFA) date
for&#xA0;trastuzumab deruxtecan, a HER2-targeting antibody drug
conjugate (ADC) and potential new medicine for the treatment of
HER2-positive metastatic breast cancer,&#xA0;is set for the second
quarter of 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">
Jos&#xE9; Baselga, Executive Vice President, Oncology R&amp;D,
said:&#xA0;"Trastuzumab deruxtecan has the potential to transform
the treatment landscape for patients with HER2-positive metastatic
breast cancer who have limited treatment options
today</font><font style="color: #000000; background-color: #FFFFFF">.&#xA0;</font><font style="color: #000000">This
Priority Review draws on the strength and the consistency of
results seen in the Phase I and Phase II trials and is a critical
step on the journey to deliver this potential new medicine to
patients."</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">
Antoine Yver, Executive Vice President and Global Head, Oncology
Research and Development, Daiichi Sankyo, said: "We are pleased
that the FDA has accepted the application and granted Priority
Review, as we believe trastuzumab deruxtecan has the potential to
redefine the treatment of patients with HER2-positive metastatic
breast cancer. Following the recent regulatory submission in Japan,
we look forward to working closely with regulatory authorities to
bring trastuzumab deruxtecan to patients in the US and Japan as
soon as possible."</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #373737; background-color: #FFFFFF; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Trastuzumab deruxtecan was previously granted US FDA Breakthrough
Therapy Designation and Fast Track designation.&#xA0;The BLA is
based on the combination of data from the Phase I trial published
in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
Lancet Oncology</font><font style="font-size: 70%; vertical-align: top; color: #000000">&#xA0;</font><font style="color: #000000">and
the pivotal Phase II DESTINY-Breast01 trial.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;The
response rate observed in DESTINY-Breast01, as assessed by an
independent review committee, validated the clinical activity
observed in the Phase I trial. Detailed data from DESTINY-Breast01
will be presented at the forthcoming San Antonio Breast Cancer
Symposium in December.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #FF0000; 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 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 found
on the surface of some cancer cells that is associated with
aggressive disease and poorer prognosis in breast cancer
patients.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;To
be considered HER2-positive, tumour cancer cells are usually tested
by one of two methods: immunohistochemistry (IHC) or fluorescent in
situ hybridisation (FISH). IHC test results are reported as: 0, IHC
1+, IHC 2+, or IHC 3+</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">.A
finding of IHC 3+ and/or FISH amplification is considered
positive</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">.&#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: 16px">
&#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-weight: bold; color: #000000">
About HER2-positive breast cancer</font><font style="color: #000000">&#xA0;</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Approximately one in five breast cancers are
HER2-positive.</font><font style="font-size: 70%; vertical-align: top; color: #000000; font-family: Times New Roman">3,4</font><font style="font-size: 70%; vertical-align: top; color: #000000">&#xA0;</font><font style="color: #000000">Despite
recent improvements and approvals of new medicines, there remains
significant clinical needs for patients with advanced HER2-positive
metastatic breast cancer.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5,6</font><font style="color: #000000">&#xA0;This
disease remains incurable with patients eventually progressing
after available treatments.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5,6</font><font style="color: #000000">&#xA0;Additionally,
there are currently no approved HER2-targeted medicines for HER2
FISH negative, IHC 2+ or IHC 1+ tumours.</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">
About DESTINY-Breast01</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">
DESTINY-Breast01 is a pivotal Phase II, open-label, global,
multicentre, two-part trial evaluating the safety and efficacy of
trastuzumab deruxtecan in patients with HER2-positive unresectable
and/or metastatic breast cancer previously treated with trastuzumab
emtansine. The primary endpoint of the trial is objective response
rate, as determined by independent central review. Secondary
objectives include duration of response, disease control rate,
clinical benefit rate, progression-free survival and overall
survival. Enrolment into DESTINY-Breast01 was completed in
September 2018 with 253 patients at more than 100 sites across
North America, Europe, Japan and other countries in
Asia.</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">
The safety and tolerability profile of trastuzumab deruxtecan in
DESTINY-Breast01 was consistent with the Phase I trial data
published in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
Lancet Oncology</font><font style="color: #000000">, in which the
most common adverse events (&#x2265;30 percent, any grade) included
nausea, decreased appetite, vomiting, alopecia, fatigue, anaemia,
diarrhoea and constipation. Cases of drug-related interstitial lung
disease and pneumonitis, including grade 5 events, have also been
reported in the clinical development programme.</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-weight: bold; font-family: Times New Roman; font-size: 13px">
About trastuzumab deruxtecan</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">
Trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in
US only; trastuzumab deruxtecan in other regions of world) is the
lead product in the investigational ADC Franchise of the Daiichi
Sankyo Cancer Enterprise 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></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
A comprehensive development programme is underway in North America,
Europe and Asia, including five pivotal trials in HER2-expressing
metastatic breast and gastric cancers, including a trial in
patients with metastatic breast cancer and low levels of HER2
expression. Phase II trials are underway for HER2-expressing
advanced colorectal cancer, as well as metastatic non-squamous
HER2-overexpressing or HER2-mutated non-small cell lung cancer.
Trials in combination with other anticancer treatments, such as
immunotherapy, are also underway.</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">
Regulatory submission of trastuzumab deruxtecan was recently made
to Japan's Ministry of Health, Labour and Welfare (MHLW) for the
treatment of patients with HER2-positive metastatic breast cancer.
It also received SAKIGAKE designation for the treatment of advanced
HER2-positive gastric or gastroesophageal junction cancer by
Japan's MHLW.</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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References</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
1. Tamura, K, et al. Trastuzuamb deruxtecan (DS-8201a) in patients
with advanced HER2-positive breast cancer previously treated with
trastuzumab emtansine: a dose-expansion, phase 1
study.&#xA0;</font><font style="font-style: italic; color: #000000">Lancet
Oncol</font><font style="color: #000000">.
2019;20(6):816-826.</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
2. American Cancer Society. Breast Cancer HER2 Status. Available
at&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html</font><font style="color: #000000">.
Accessed August 2019.</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
3.Tandon A,&#xA0;</font><font style="font-style: italic; color: #000000">et al</font><font style="color: #000000">. HER-2/neu Oncogene Protein and Prognosis in
Breast Cancer.&#xA0;</font><font style="font-style: italic; color: #000000">J Clin
Oncol</font><font style="color: #000000">.
1989;7(8):1120-8.</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
4. Sledge G,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;Past, Present, and Future Challenges in
Breast Cancer Treatment.&#xA0;</font><font style="font-style: italic; color: #000000">J Clin
Oncol</font><font style="color: #000000">.
2014;32(19):1979-1986.</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
5.de Melo Gagliato D,&#xA0;</font><font style="font-style: italic; color: #000000">et al</font><font style="color: #000000">. Mechanisms of Resistance and Sensitivity to
Anti-HER2 Therapies in HER2+ Breast
Cancer.&#xA0;</font><font style="font-style: italic; color: #000000">Oncotarget</font><font style="color: #000000">.
2016;7(39):64431-46.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">
6. National Comprehensive Cancer Network (NCCN). NCCN Guidelines.
Breast Cancer. Available at&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://nccn.org</font><font style="color: #000000; font-size: 13px">.
Accessed August 2019.</font></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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Pursuant
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<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date:
<font style="font-weight: bold; font-size: 13px">17 October
2019</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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