<SEC-DOCUMENT>0001654954-22-016664.txt : 20221219
<SEC-HEADER>0001654954-22-016664.hdr.sgml : 20221219
<ACCEPTANCE-DATETIME>20221219082306
ACCESSION NUMBER:		0001654954-22-016664
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20221219
FILED AS OF DATE:		20221219
DATE AS OF CHANGE:		20221219

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		221469662

	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>a0816k.htm
<DESCRIPTION>ENHERTU APPROVED IN THE EU FOR PATIENTS WITH PREVIOUSLY TREATED HER2-POSITIVE ADVANCED GASTRIC CANCER
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1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold">Enhertu approved in the EU for patients with
previously treated HER2-positive advanced gastric
cancer</font></div>
</div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
19 December 2022 07:15 GMT</font></div>
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&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; font-style: italic; color: #000000">
Enhertu</font><font style="color: #000000">&#xA0;</font><font style="font-weight: bold; color: #000000">approved
in the EU for patients with previously treated HER2-positive
advanced gastric cancer</font></font></div>
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<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">
First HER2-directed medicine to be approved for gastric cancer in
the EU in more than a decade</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">
&#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">
Based on DESTINY-Gastric02 and DESTINY-Gastric01 where AstraZeneca
and Daiichi Sankyo's Enhertu demonstrated clinically meaningful
efficacy</font></div>
<div style="text-align: left; 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"><font style="color: #000000">
AstraZeneca and Daiichi Sankyo's&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;(trastuzumab deruxtecan) has been approved
in the European Union (EU) as monotherapy for the treatment of
adult patients with advanced HER2-positive gastric or
gastroesophageal junction (GEJ) adenocarcinoma who have received a
prior trastuzumab-based regimen.</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</font><font style="color: #000000">&#xA0;is a specifically
engineered HER2-directed antibody drug conjugate (ADC) being
jointly developed and commercialised by AstraZeneca and Daiichi
Sankyo.</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 approval by the European Commission follows
the&#xA0;</font><font style="text-decoration: underline; color: #0000FF">positive
opinion</font><font style="color: #000000">&#xA0;of the Committee
for Medicinal Products for Human Use in November 2022 and is based
on results from the&#xA0;DESTINY-Gastric02 and DESTINY-Gastric01
Phase II trials.</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">
In DESTINY-Gastric02, which enrolled&#xA0;patients from North
America and Europe,&#xA0;treatment with&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;resulted in a confirmed objective response
rate (ORR) of 41.8% as&#xA0;assessed by independent central review
(ICR). Median duration of response (DoR) was 8.1
months.</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">
In DESTINY-Gastric01, which enrolled patients from Japan and South
Korea, treatment with&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;resulted in a confirmed ORR&#xA0;of 40.5%
versus 11.3% with chemotherapy (irinotecan or paclitaxel) as
assessed by ICR. The median DoR was 11.3 months
with&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;versus 3.9 months with chemotherapy.
Patients treated with&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;had a 41% reduction in the risk of death
versus patients treated with chemotherapy (based on a hazard ratio
of 0.59; 95% confidence interval: 0.39-0.88; p=0.0097) with a
median overall survival (OS) of 12.5 months versus 8.4
months.</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; background-color: #FEFEFE">
Approximately 136,000 cases of gastric cancer are diagnosed
annually in Europe, where it represents the sixth leading cause of
cancer death.</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FEFEFE">1,2</font><font style="color: #000000; background-color: #FEFEFE">&#xA0;Gastric
cancer is typically diagnosed in the advanced stage. Even when the
disease is diagnosed at earlier stages, the survival rate remains
modest.</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FEFEFE">3,4</font><font style="color: #000000; background-color: #FEFEFE">&#xA0;Approximately
one in five gastric cancers are HER2-positive.</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FEFEFE">5,6</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FEFEFE; 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; background-color: #FEFEFE">
Eric Van Cutsem, MD, PhD,</font><font style="color: #000000">&#xA0;Head of Department of Oncology at the
University of Leuven, Belgium and Founding Chair of the
ESMO-GI/World Congress of Gastrointestinal
Cancers</font><font style="color: #000000; background-color: #FEFEFE">,</font><font style="color: #000000">&#xA0;said: "To</font><font style="color: #000000; background-color: #FEFEFE">day's news is a welcome
advance for</font><font style="color: #000000">&#xA0;patients with
HER2-positive advanced gastric cancer. P</font><font style="color: #000000; background-color: #FEFEFE">atients with this
disease face poor outcomes following progression on initial
treatment with a HER2-directed medicine</font><font style="color: #000000">&#xA0;as many do not respond to further treatment,
and even those that do respond often do not have durable
responses</font><font style="color: #000000; background-color: #FEFEFE">. D</font><font style="color: #000000">ata from the&#xA0;</font><font style="color: #000000; background-color: #FEFEFE">DESTINY-Gastric0</font><font style="color: #000000">2
and DESTINY-Gastric01&#xA0;</font><font style="color: #000000; background-color: #FEFEFE">trials</font><font style="color: #000000">&#xA0;support&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FEFEFE">Enhertu</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; background-color: #FEFEFE">becoming
a new standard of care for patients</font><font style="color: #000000">&#xA0;in this setting</font><font style="color: #000000; background-color: #FEFEFE">."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FEFEFE; 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">
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
AstraZeneca, said:&#xA0;</font><font style="color: #000000; background-color: #FEFEFE">"Today's important
approval makes&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FEFEFE">Enhertu</font><font style="color: #000000">&#xA0;the
first HER2-directed medicine to be approved for gastric cancer in
the European Union in more than a decade. Patients across the EU
with advanced HER2-positive disease who have progressed following
treatment in the first-line setting, may now have the opportunity
to&#xA0;benefit from treatment with&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Ken Keller, Global Head of Oncology Business, and President and
CEO, Daiichi Sankyo, Inc., said</font><font style="color: #000000; background-color: #FEFEFE">: "</font><font style="font-style: italic; color: #000000; background-color: #FEFEFE">Enhertu</font><font style="color: #000000; background-color: #FEFEFE">&#xA0;is
the first antibody drug conjugate to be approved in Europe for
advanced gastric cancer, representing&#xA0;a major advance in
treating this difficult-to-treat cancer.</font><font style="color: #000000">&#xA0;With this&#xA0;</font><font style="color: #000000; background-color: #FEFEFE">approval, we can now
offer patients with previously treated HER2-positive gastric cancer
a treatment with clinically meaningful
efficacy."</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-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In both trials, the safety profiles observed in patients treated
with&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;were consistent with those seen in other
trials of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;with no new safety signals
identified.</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</font><font style="color: #000000">&#xA0;is also approved
in the US and several other countries for locally advanced or
metastatic HER2-positive gastric 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="text-decoration: underline; color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Notes</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">
Financial considerations</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">
Following EU approval, an amount of $35m is due from AstraZeneca to
Daiichi Sankyo as a milestone payment for the previously treated
HER2-positive gastric indication. The milestone payment will be
capitalised as an addition to the upfront payment made by
AstraZeneca to Daiichi Sankyo in 2019 and subsequent capitalised
milestones.</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">
Sales of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;in most EU territories are recognised by
Daiichi Sankyo. AstraZeneca reports its share of gross profit
margin from&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;sales in those territories as collaboration
revenue in the Company's financial statements. AstraZeneca will
record product sales in respect of sales made in territories where
AstraZeneca is the selling party.</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">
Further details on the financial arrangements were set out in
the&#xA0;</font><font style="text-decoration: underline; color: #0000FF">March 2019
announcement</font><font style="color: #000000">&#xA0;of the
collaboration.</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-positive gastric 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">
Gastric (stomach) cancer is the fifth most common cancer worldwide
and the fourth highest leading cause of cancer mortality, with a
five-year global survival rate of 5% to 10% for advanced or
metastatic disease.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3,7,8</font><font style="color: #000000">&#xA0;Approximately
one million new patients were diagnosed with gastric cancer in
2020, with 768,000 deaths reported globally.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;In
Europe, approximately 136,000 cases of gastric cancer are diagnosed
annually, and Eastern Europe has the second highest incidence of
gastric cancer worldwide after Eastern Asia.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,8</font><font style="color: #000000">&#xA0;Gastric
cancer is the sixth leading cause of cancer death in Europe and is
typically diagnosed in the advanced stage. Even when diagnosed in
earlier stages of the disease, the survival rate remains
modest.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,3,4</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">
Approximately one in five gastric cancers are
HER2-positive.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5,6</font><font style="color: #000000">&#xA0;HER2
is a tyrosine kinase receptor growth promoting protein expressed on
the surface of many types of tumours including breast, gastric,
lung and colorectal cancers.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font><font style="color: #000000">&#xA0;HER2
overexpression may be associated with a specific HER2 gene
alteration known as HER2 amplification.</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">
Recommended first-line treatment in the EU for HER2-positive
advanced or metastatic gastric cancer is combination chemotherapy
plus trastuzumab, an anti-HER2 medicine, which has been shown to
improve survival outcomes when added to
chemotherapy.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9,10</font><font style="color: #000000">&#xA0;For
patients with metastatic gastric cancer that progresses following
initial treatment with a trastuzumab-based regimen, there were
previously no other approved HER2-directed medicines in the EU
prior to the approval of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">.</font><font style="font-size: 70%; vertical-align: top; color: #000000">7,11,12</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
DESTINY-Gastric02</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-Gastric02 is an open-label, single-arm Phase II trial in
patients evaluating the efficacy and safety
of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;(6.4mg/kg) in patients with HER2-positive
metastatic and/or unresectable gastric or GEJ adenocarcinoma with
disease progression on or after a trastuzumab-containing
regimen.</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 primary endpoint of DESTINY-Gastric02 is confirmed ORR based on
ICR. Secondary endpoints include progression-free survival (PFS),
OS, DoR and safety.</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">
DESTINY-Gastric02 enrolled 79 patients at multiple sites in North
America and Europe.&#xA0;For more information about the trial,
visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">ClinicalTrials.gov</font><font style="font-style: italic; color: #000000">.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
DESTINY-Gastric01</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-Gastric01 is a randomised, open-label Phase II trial
evaluating the efficacy and safety of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;(6.4mg/kg) in patients with primarily
HER2-positive&#xA0;(defined as immunohistochemistry [IHC] 3+ or IHC
2+/in-situ hybridisation [ISH]+) advanced gastric cancer or GEJ
adenocarcinoma with disease progression following two or more prior
treatment regimens including fluoropyrimidine (5-FU), platinum
chemotherapy and trastuzumab. Patients were randomised 2:1 to
receive&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;or physician's choice of chemotherapy
(paclitaxel or irinotecan monotherapy).</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 primary endpoint of DESTINY-Gastric01 is ORR. Secondary
endpoints include OS, PFS, DoR, disease control rate and time to
treatment failure, as well as pharmacokinetic and safety
endpoints.</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">
DESTINY-Gastric01 enrolled 187 patients at multiple sites in Japan
and South Korea. For more information about the trial,
visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">ClinicalTrials.gov</font><font style="font-style: italic; color: #000000">.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="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-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&#xA0;</font><font style="color: #000000">is a HER2-directed
ADC. Designed using Daiichi Sankyo's proprietary DXd ADC
technology,&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu&#xA0;</font><font style="color: #000000">is
the lead ADC in the oncology portfolio of Daiichi Sankyo and the
most advanced programme in AstraZeneca's ADC scientific
platform.&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;consists of a HER2 monoclonal antibody
attached to a topoisomerase I inhibitor payload, an exatecan
derivative, via a stable tetrapeptide-based cleavable
linker.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Enhertu</font><font style="color: #000000">&#xA0;(5.4mg/kg) is
approved in more than 40 countries for the treatment of adult
patients with unresectable or metastatic HER2-positive breast
cancer who have received a (or one or more) prior anti-HER2-based
regimen either in the metastatic setting, or in the neoadjuvant or
adjuvant setting and have developed disease recurrence during or
within six months of completing therapy based on the results from
the DESTINY-Breast03 trial.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Enhertu</font><font style="color: #000000">&#xA0;(5.4mg/kg) is
approved in several countries 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 results from the DESTINY-Breast01 trial.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Enhertu</font><font style="color: #000000">&#xA0;(5.4mg/kg) is
approved in Brazil and the US for the treatment of adult patients
with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-)
breast cancer who have received a prior chemotherapy in the
metastatic setting or developed disease recurrence during or within
six months of completing adjuvant chemotherapy based on the results
from the DESTINY-Breast04 trial.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 16px"><font style="font-style: italic; color: #000000; font-size: 13px">
Enhertu</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">(5.4mg/kg)
is approved under accelerated approval in the US for the treatment
of adult patients with unresectable or metastatic non-small cell
lung cancer whose tumours have activating HER2 (ERBB2) mutations,
as detected by an FDA-approved test, and who have received a prior
systemic therapy, based on the results of the DESTINY-Lung02 trial.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Enhertu</font><font style="color: #000000">&#xA0;(6.4mg/kg) is
approved in several countries for the treatment of adult patients
with locally advanced or metastatic HER2-positive gastric or GEJ
who have received a prior trastuzumab-based regimen based on the
results from the DESTINY-Gastric01 and/or DESTINY-Gastric02
trial.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; font-style: italic; color: #000000">
Enhertu</font><font style="color: #000000">&#xA0;</font><font style="font-weight: bold; color: #000000">development
programme</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,
evaluating the efficacy and safety of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu&#xA0;</font><font style="color: #000000">monotherapy
across multiple HER2-targetable cancers, including breast, gastric,
lung and colorectal 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="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">
Regulatory applications for&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;in breast, non-small cell lung and gastric
cancer are currently under review in several
countries.</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">
Daiichi Sankyo collaboration</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as Daiichi
Sankyo] and AstraZeneca 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;(a HER2-directed ADC)
in&#xA0;</font><font style="text-decoration: underline; color: #0000FF">March
2019</font><font style="color: #000000">, and datopotamab
deruxtecan (DS-1062; a TROP2-directed ADC)
in&#xA0;</font><font style="text-decoration: underline; color: #0000FF">July
2020</font><font style="color: #000000">, except in Japan where
Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is
responsible for the manufacturing and supply
of&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;and datopotamab
deruxtecan.</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: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca in gastrointestinal cancers</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 broad development programme for the treatment of
gastrointestinal (GI) cancers across several medicines and a
variety of tumour types and stages of disease. In 2020, GI cancers
collectively represented approximately 5.1 million new cancer cases
leading to approximately 3.6 million deaths.</font><font style="font-size: 70%; vertical-align: top; color: #000000">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="color: #000000; font-family: Times New Roman; font-size: 13px">
Within this programme, the Company is committed to improving
outcomes in gastric, liver, biliary tract, oesophageal, pancreatic
and colorectal cancers.</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;(durvalumab)
is&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">approved in the US in
combination with chemotherapy (gemcitabine plus cisplatin) for
advanced biliary tract cancer and in combination
with&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Imjudo</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;in
unresectable</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">hepatocellular
carcinoma.</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000; background-color: #FFFFFF">&#x202F;is being
assessed in&#x202F;combinations, including
with&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Imjudo</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;in
liver, oesophageal&#x202F;and gastric cancers in an extensive
development programme spanning early to late-stage
disease&#x202F;across settings.</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</font><font style="color: #000000">, a HER2-directed
antibody drug conjugate, is approved in HER2-positive advanced
gastric cancer and is being assessed in colorectal
cancer.&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;is jointly developed and commercialised by
AstraZeneca and Daiichi Sankyo.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Lynparza</font><font style="color: #000000">&#xA0;(olaparib), a
first-in-class PARP inhibitor, is approved in BRCA-mutated
metastatic pancreatic cancer.&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;is developed and commercialised in
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References</font></div>
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PC, et al.&#xA0;Trastuzumab emtansine versus taxane use for
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">12.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Satoh
T, et al. Lapatinib plus paclitaxel versus paclitaxel alone in the
second-line treatment of HER2-amplified advanced gastric cancer in
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<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">13.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">WHO.
World Cancer Fact Sheet. Available at:</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf</font><font style="color: #000000; font-size: 13px">.
Accessed December 2022.</font></font></div>
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