<SEC-DOCUMENT>0001654954-22-012816.txt : 20220922
<SEC-HEADER>0001654954-22-012816.hdr.sgml : 20220922
<ACCEPTANCE-DATETIME>20220922064822
ACCESSION NUMBER:		0001654954-22-012816
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20220922
FILED AS OF DATE:		20220922
DATE AS OF CHANGE:		20220922

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:		221257806

	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>a2781a.htm
<DESCRIPTION>LYNPARZA APPROVED IN CHINA FOR OVARIAN CANCER
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1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Lynparza approved in China for ovarian cancer</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
22 September 2022 07:00 BST</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; font-size: 13px">
Lynparza</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; color: #000000; font-size: 13px">approved
in China as 1st-line maintenance treatment with bevacizumab for
HRD-positive advanced ovarian cancer</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
One in two women with advanced ovarian cancer has an HRD-positive
tumour</font></div>
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<font style="color: #000000; background-color: #FFFFFF; font-weight: bold; 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">
AstraZeneca and MSD's&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;(olaparib) has been approved in China
for</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">the
maintenance treatment of adult patients with advanced epithelial
ovarian, fallopian tube or primary peritoneal cancer who are in
complete or partial response to 1st-line platinum-based
chemotherapy in combination with bevacizumab, and whose cancer is
associated with homologous recombination deficiency (HRD)-positive
status.</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 China, ovarian cancer is the third most common gynaecologic
cancer, with a five-year survival rate of approximately
39%,</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">largely
because more than 70% of women are diagnosed with advanced disease
(Stage III or IV).</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</font><font style="color: #000000">&#xA0;In
2020, there were over 55,000 new cases of ovarian cancer in
China.</font><font style="font-size: 70%; vertical-align: top; color: #000000">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>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The approval by China's National Medical Products Administration
was based on an HRD-positive subgroup exploratory analysis of the
PAOLA-1 Phase III trial which showed&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;plus bevacizumab demonstrated a substantial
progression-free survival (PFS) improvement versus bevacizumab
alone for patients with HRD-positive advanced ovarian cancer.
During European Society for Medical Oncology Congress (ESMO)
2022,</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">the
final overall survival (OS) results</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">were
presented from the PAOLA-1 Phase III trial demonstrating
that&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;plus bevacizumab provided a clinically
meaningful improvement in overall survival in HRD-positive advanced
ovarian cancer.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Professor Ding Ma, Member of the Chinese Academy of Engineering,
said: "Ovarian cancer has the highest fatality rate among
gynaecologic cancers in China. The emergence of PARP inhibitors and
their application in the 1st-line treatment of ovarian cancer could
help patients delay disease progression and achieve long-term
remission. In the PAOLA-1 trial, the combination of olaparib and
bevacizumab</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">demonstrated</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">clinically
meaningful improvements in overall survival. This
approval</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">provides
HRD-positive patients with a new option for 1st-line maintenance
therapy."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Professor Beihua Kong, Chairman of the Gynaecological Oncology
Branch of the Chinese Medical Association, said: "Ovarian cancer
has entered the era of precision medicine, and HRD detection
(including BRCA1/2 mutations) has important clinical value for
newly diagnosed patients with advanced ovarian cancer, to help
guide first-line treatment decisions. The approval of the
combination of olaparib and bevacizumab brings a clinically
meaningful survival benefit to HRD-positive patients, and further
reflects the importance of a precision approach to help guide
treatment decisions in ovarian cancer."</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">
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
AstraZeneca, said: "The maintenance treatment
of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;in combination with bevacizumab has shown to
both improve progression-free survival and provide a clinically
meaningful improvement in overall survival in patients with
HRD-positive advanced ovarian cancer following response to
platinum-based chemotherapy. I am thrilled we can now bring this
targeted treatment option to these patients in
China."</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">
Dr Eliav Barr, Senior Vice President, Head of Global Clinical
Development and Chief Medical Officer, MSD Research Laboratories,
said:&#xA0;"This approval is an important milestone for patients
with newly diagnosed advanced ovarian cancer in China and
underscores the critical importance of HRD testing for all women
with advanced ovarian cancer at the point of
diagnosis."</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="text-decoration: underline; color: #0000FF">
The initial results</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">from
the PAOLA-1 Phase III trial</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">showed
that&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;plus bevacizumab reduced the risk of disease
progression or death by 67% in the subgroup of patients with
HRD-positive advanced ovarian cancer (based on a hazard ratio [HR]
of 0.33; 95% confidence interval [CI] 0.25-0.45 from the
pre-specified exploratory analysis).&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;plus bevacizumab also improved PFS to a
median of 46.8 versus 17.6 months with bevacizumab alone in this
patient population. The primary endpoint in the intent-to-treat
population was a statistically significant and clinically
meaningful improvement in PFS. The data from the PAOLA-1 trial was
published in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
New England Journal of Medicine</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">in
2019.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="text-decoration: underline; color: #0000FF">
Further results</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">from
the five-year analysis of the PAOLA-1 trial recently presented at
the ESMO 2022 showed&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;plus bevacizumab increased median overall
survival to 56.5 months versus 51.6 months with bevacizumab alone,
in patients with newly diagnosed advanced ovarian cancer
irrespective of HRD status. This increase was not statistically
significant. In HRD-positive patients,&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;plus bevacizumab provided a clinically
meaningful improvement in overall survival, reducing the risk of
death by 38% versus bevacizumab (based on a HR of 0.62; 95% CI
0.45-0.85 from the pre-specified exploratory sub-group analysis)
despite PAOLA-1 having 30% Stage IV patients.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">The
safety and tolerability profile of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;in this trial was in line with that observed
in prior clinical trials, with no new safety
signals.</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="font-style: italic; color: #000000">
Lynparza</font><font style="color: #000000">&#xA0;in combination
with bevacizumab is&#xA0;</font><font style="text-decoration: underline; color: #0000FF">approved in the
US</font><font style="color: #000000">,&#xA0; and several other
countries as a 1st-line maintenance treatment for patients with
HRD-positive advanced ovarian cancer and is currently under
regulatory review in other countries around the world. In
China,&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;is</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">approved</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">for
the treatment of BRCA-mutated metastatic castration-resistant
prostate cancer as well as a 1st-line maintenance therapy
in</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">BRCA-mutated
advanced ovarian cancer</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="font-weight: bold; text-decoration: underline; color: #000000">
Notes</font><font style="color: #A4262C">&#xA0;</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Ovarian 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">
Ovarian cancer is the eighth most common cancer in women
worldwide.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4</font><font style="color: #000000">&#xA0;There
were more than 313,000 new cases of ovarian cancer in 2020, and
over 207,000 deaths.&#xA0;The 5-year survival rate of newly
diagnosed advanced ovarian cancer patients has typically been
30-50%.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5,6</font><font style="color: #000000">&#xA0;Roughly
half of women with advanced ovarian cancer have homologous
recombination deficiency (HRD)-positive tumours including those
with a BRCA mutation and up to one in five women have a BRCA
mutation.</font><font style="font-size: 70%; vertical-align: top; color: #000000">7-9</font><font style="color: #000000">&#xA0;The
primary aim of 1st-line treatment is to delay disease progression
for as long as possible with the intent to achieve long-term
remission.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10-12</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">
PAOLA-1</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">
PAOLA-1 is a double-blinded Phase III trial testing the efficacy
and safety of&#x202F;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#x202F;added to standard of care bevacizumab
versus bevacizumab alone, as a 1st-line maintenance treatment for
newly diagnosed advanced FIGO Stage III-IV high-grade serous or
endometroid ovarian, fallopian tube, or peritoneal cancer patients
who had a complete or partial response to 1st-line treatment with
platinum-based chemotherapy and bevacizumab. AstraZeneca and
MSD</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">announced
in August 2019</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">that
the trial met its primary endpoint of PFS in the overall trial
population.</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 primary analysis of the PAOLA-1 Phase III trial showed
that&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">, in combination with bevacizumab maintenance
treatment, reduced the risk of disease progression or death by 67%
(based on a HR of 0.33; 95% CI 0.25-0.45) in the subgroup of
patients with HRD-positive advanced ovarian cancer. The addition
of&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;improved PFS to a median of 46.8 months
versus 17.6 with bevacizumab alone in this patient
population.</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">
Updated results from the five-year analysis of the PAOLA-1 Phase
III trial demonstrate that in a pre-specified exploratory subgroup
analysis of HRD-positive patients,&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;plus bevacizumab provided a clinically
meaningful improvement in overall survival, reducing the risk of
death by 38% versus bevacizumab (based on a HR of 0.62; 95% CI
0.45-0.85). In addition, 65.5% of patients treated
with&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;plus bevacizumab were still alive at five
years versus 48.4% of those treated with bevacizumab
alone.&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;plus bevacizumab also improved median PFS to
almost four years (46.8 months) versus 17.6 months with bevacizumab
plus placebo, and 46.1% of patients treated
with&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;plus bevacizumab remain progression free at
five years versus 19.2% of patients treated with bevacizumab
alone.</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">
PAOLA-1 is an ENGOT (European Network of Gynaecological Oncological
Trial groups) trial, sponsored by ARCAGY Research (Association de
Recherche sur les CAncers dont GYn&#xE9;cologiques) on behalf of
GINECO (Groupe d'Investigateurs National des Etudes des Cancers
Ovariens et du sein), lead group&#xA0;for the PAOLA-1 trial.
ARCAGY-GINECO is an academic group specialising in clinical and
translational research in patients' gynaecological cancers,
labelled by the French National Cancer Institute (INCa), and a
member of the GCIG (Gynecologic Cancer InterGroup).</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Homologous recombination deficiency</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">
HRD, which defines a subgroup of ovarian cancer, encompasses a wide
range of genetic abnormalities, including BRCA mutations and
beyond. As with BRCA gene mutations, HRD interferes with normal
cell DNA repair mechanisms and confers sensitivity to PARP
inhibitors including&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">.</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="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-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Lynparza</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; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">(olaparib)
is a 1st-in-class PARP inhibitor and the first targeted treatment
to block DNA damage response (DDR) in cells/tumours harbouring a
deficiency in homologous recombination repair (HRR), such as
mutations in BRCA1 and/or BRCA2. Inhibition of PARP
with&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;leads to the trapping of PARP bound to DNA
single-strand breaks, stalling of replication forks, their collapse
and the generation of DNA double-strand breaks and cancer cell
death.&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;is being tested in a range of PARP-dependent
tumour types with defects and dependencies in the DDR
pathway.</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; background-color: #FFFFFF">
Lynparza</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">is
currently approved in a number of countries across multiple tumour
types including maintenance treatment of platinum-sensitive
relapsed ovarian cancer and as both monotherapy and in combination
with bevacizumab for the 1st-line maintenance treatment of
BRCA-mutated (BRCAm) and HRD-positive advanced ovarian cancer,
respectively; for gBRCAm, HER2-negative metastatic breast cancer
(in the EU and Japan this includes locally advanced breast cancer);
for gBRCAm, HER2-negative high-risk early breast cancer (in Japan
this includes all BRCAm HER2-negative high-risk early breast
cancer); for gBRCAm metastatic pancreatic cancer; and HRR
gene-mutated metastatic castration-resistant prostate cancer (BRCAm
only in the EU and Japan).</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">In
China,&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;is</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">approved</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">for
the treatment of BRCA-mutated metastatic castration-resistant
prostate cancer as well as a 1</font><font style="font-size: 70%; vertical-align: top; color: #000000">st</font><font style="color: #000000">-line
maintenance therapy in</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">BRCA-mutated
advanced ovarian cancer</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="font-style: italic; color: #000000">
Lynparza,</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">which
is being jointly developed and commercialised by AstraZeneca and
MSD, has been used to treat over 75,000 patients
worldwide.&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;has a broad clinical trial development
programme, and AstraZeneca and MSD are working together to
understand how it may affect multiple PARP-dependent tumours as a
monotherapy and in combination across multiple cancer
types.&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;is the foundation of AstraZeneca's
industry-leading portfolio of potential new medicines targeting DDR
mechanisms in cancer cells.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
The AstraZeneca and MSD strategic oncology
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">
In July 2017, AstraZeneca and Merck &amp; Co., Inc., Kenilworth,
NJ, US, known as MSD outside the US and Canada, announced a global
strategic oncology collaboration to co-develop and
co-commercialise&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">, the world's first PARP inhibitor,
and&#xA0;</font><font style="font-style: italic; color: #000000">Koselugo</font><font style="color: #000000">&#xA0;(selumetinib), a MEK inhibitor, for multiple
cancer types. Working together, the companies will
develop&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;and&#xA0;</font><font style="font-style: italic; color: #000000">Koselugo</font><font style="color: #000000">&#xA0;in combination with other potential new
medicines and as monotherapies. Independently, the companies will
develop&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;and&#xA0;</font><font style="font-style: italic; color: #000000">Koselugo</font><font style="color: #000000">&#xA0;in combination with their respective PD-L1
and PD-1 medicines.</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">
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 is leading a revolution in oncology with the ambition
to provide cures for cancer in every form, following the science to
understand cancer and all its complexities to discover, develop and
deliver life-changing medicines to 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="color: #000000; font-family: Times New Roman; font-size: 13px">
The Company's focus is on some of the most challenging cancers. It
is through persistent innovation that AstraZeneca has built one of
the most diverse portfolios and pipelines in the industry, with the
potential to catalyse changes in the practice of medicine and
transform the patient experience.</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">
By harnessing the power of six scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies
- and by championing the development of personalised combinations,
AstraZeneca has the vision to redefine cancer treatment and, one
day, eliminate cancer as a cause of death.</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
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</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">(LSE/STO/Nasdaq:
AZN)</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">is
a global, science-led biopharmaceutical company that focuses on the
discovery, development and commercialisation of prescription
medicines, primarily for the treatment of diseases in three therapy
areas - Oncology, Cardiovascular, Renal &amp; Metabolism, and
Respiratory &amp; Immunology. Based in Cambridge, UK, AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. Please
visit</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">and
follow the Company on Twitter</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">@</font><font style="text-decoration: underline; color: #0000FF">AstraZeneca</font><font style="color: #0000FF">.</font></font></div>
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References</font></div>
<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">1.&#xA0;&#xA0; Jiang X,&#xA0;</font><font style="font-style: italic; color: #000000">et al</font><font style="color: #000000">. Epidemiology of gynecologic cancers in
China.&#xA0;</font><font style="font-style: italic; color: #000000">J Gynecol
Oncol</font><font style="color: #000000">. 2018 Jan; 29(1):
e7.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px;">&#xA0;</font></div>
<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">2.&#xA0;&#xA0; Bu H,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;BRCA mutation frequency and clinical
features of ovarian cancer patients: A report from a Chinese study
group.&#xA0;</font><font style="font-style: italic; color: #000000">J Obstet Gynaecol
Res</font><font style="color: #000000">. 2019
Nov;45(11):2267-2274.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px;">&#xA0;</font></div>
<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">3.&#xA0;&#xA0; Globocan. China Globocan 2020.
Available at</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf</font><font style="color: #000000">.
Accessed September 2022.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px;">&#xA0;</font></div>
<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">4.&#xA0;&#xA0;&#xA0;Momenimovahed
Z,&#xA0;</font><font style="font-style: italic; color: #000000">et
al.&#xA0;</font><font style="color: #000000">Ovarian Cancer in The
World: Epidemiology And Risk Factors</font><font style="font-style: italic; color: #000000">. Int J Womens
Health</font><font style="color: #000000">. 2019 Apr
30;11:287-299.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">5.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Torre
A,&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">et
al</font><font style="color: #000000; font-size: 13px">. Ovarian
Cancer Statistics.&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">CA Cancer J
Clin</font><font style="color: #000000; font-size: 13px">. 2018
Jul; 68(4):284-296.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">6.&#xA0;&#xA0; National Cancer
Institute. Cancer Stat Facts: Ovarian Cancer.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Available
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September 2022.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">9.&#xA0;&#xA0; Bonadio R,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;Homologous recombination deficiency in
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">10.&#xA0; Raja F,&#xA0;</font><font style="font-style: italic; color: #000000">et al</font><font style="color: #000000">. Optimal first-line treatment in ovarian
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">12.&#xA0; Ledermann J,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;Newly diagnosed and relapsed epithelial
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<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">13.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Moore
K,&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">et
al.</font><font style="color: #000000; font-size: 13px">&#xA0;Maintenance Olaparib in
Patients with Newly Diagnosed Advanced Ovarian
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Journal of Medicine</font><font style="color: #000000; font-size: 13px">. 2019;379(26),
pp.2495-2505.</font></font></div>
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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
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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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