<SEC-DOCUMENT>0001654954-25-011461.txt : 20251006
<SEC-HEADER>0001654954-25-011461.hdr.sgml : 20251006
<ACCEPTANCE-DATETIME>20251006071850
ACCESSION NUMBER:		0001654954-25-011461
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20251006
FILED AS OF DATE:		20251006
DATE AS OF CHANGE:		20251006

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				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:		251375606

	BUSINESS ADDRESS:	
		ADDRESS IS A NON US LOCATION: 	YES
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		PROVINCE COUNTRY:   	X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		ADDRESS IS A NON US LOCATION: 	YES
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		PROVINCE COUNTRY:   	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>a1092c.htm
<DESCRIPTION>DATROWAY IMPROVED OS AND PFS IN TROPION-BREAST02
<TEXT>
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AstraZeneca PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">INDEX
TO EXHIBITS</font></div>
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<font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
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">
Datroway improved OS and PFS in TROPION-Breast02</font></div>
</div>
</div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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&#xA0;</font></div>
<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>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
6 October 2025</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="font-weight: bold; font-family: Times New Roman; font-size: 16px">
<font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;demonstrated statistically significant and
clinically meaningful improvement in overall survival as 1st-line
therapy for patients with metastatic triple-negative breast cancer
for whom immunotherapy was not an option in
TROPION-Breast02</font></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>
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<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
AstraZeneca and Daiichi Sankyo's Datroway is the first and only
therapy to significantly improve overall survival vs. chemotherapy
in this patient population</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>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Datroway also demonstrated a highly statistically significant and
clinically meaningful</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">
improvement in the dual primary endpoint of progression-free
survival</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">
&#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">
Positive high-level results from the TROPION-Breast02 Phase III
trial showed&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;(datopotamab deruxtecan) demonstrated a
statistically significant and clinically meaningful improvement for
the dual primary endpoints of overall survival (OS) and
progression-free survival (PFS) compared to investigator's choice
of chemotherapy as 1st-line treatment for patients with locally
recurrent inoperable or metastatic triple-negative breast cancer
(TNBC) for whom immunotherapy was not an
option.</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 70% of patients with metastatic TNBC are not
candidates for immunotherapy, including all patients whose tumours
do not express PD-L1 as well as patients with PD-L1 expressing
tumours who cannot receive immunotherapy due to other
factors.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;Chemotherapy
remains the 1st-line standard of care for these
patients.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</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">
Susan Galbraith, Executive Vice President, Oncology Haematology
R&amp;D, AstraZeneca, said: "TROPION-Breast02 is the only trial
ever to show an overall survival benefit in the first-line
treatment of patients with metastatic triple-negative breast cancer
for whom immunotherapy is not an option. We expect today's results
will mark an inflection point in the treatment of these patients
who have the poorest prognosis of any type of breast cancer and
urgently need better options."</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 Takeshita, Global Head, R&amp;D, Daiichi Sankyo, said:
"</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;is the first antibody drug conjugate and the
only therapy to significantly improve overall survival compared to
chemotherapy in patients with metastatic triple-negative breast
cancer for whom immunotherapy is not an option. These landmark
results from TROPION-Breast02 strengthen our confidence in our
ongoing clinical development programme for&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;in triple-negative breast cancer and other
tumour types. We look forward to discussing these data with global
regulatory authorities and to bringing&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;to patients with triple-negative breast
cancer as soon as possible."</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 safety profile of&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;was consistent with previous clinical trials
of&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;in breast cancer. These data will be
presented at an upcoming medical meeting and shared with regulatory
authorities.</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">
Datroway</font><font style="color: #000000">&#xA0;is a specifically
engineered TROP2-directed DXd antibody drug conjugate (ADC)
discovered by Daiichi Sankyo and 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">
AstraZeneca and Daiichi Sankyo are
evaluating&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;across stages and treatment settings of TNBC
in three additional Phase III trials.&#xA0;</font><font style="text-decoration: underline; color: #0000FF">TROPION-Breast03</font><font style="color: #000000">&#xA0;is
evaluating&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;with or without&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;(durvalumab)&#xA0;in patients with Stage
I-III TNBC with residual invasive disease after neoadjuvant
systemic therapy.&#xA0;</font><font style="text-decoration: underline; color: #0000FF">TROPION-Breast04</font><font style="color: #000000">&#xA0;is
evaluating neoadjuvant&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;plus&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;in patients with Stage II-III
triple-negative or hormone receptor (HR)-low, HER2-low or -negative
breast cancer.&#xA0;</font><font style="text-decoration: underline; color: #0000FF">TROPION-Breast05</font><font style="color: #000000">&#xA0;is
evaluating 1st-line&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;with or without&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;in patients with metastatic TNBC whose
tumours express PD-L1.</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">
Triple-negative breast 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">
TNBC accounts for approximately 15% of all breast cancer cases,
with an estimated 345,000 diagnoses globally each
year.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3,4</font><font style="color: #000000">&#xA0;TNBC
is diagnosed more frequently in younger and premenopausal women,
and is more prevalent in Black and Hispanic
women.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5-7</font><font style="color: #000000">&#xA0;Metastatic
TNBC is the most aggressive type of breast cancer and has the worst
prognosis, with median overall survival of just 12 to 18 months and
only about 14% of patients living five years following
diagnosis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5,8,9</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">
While some breast cancers may test positive for oestrogen
receptors, progesterone receptors or overexpression of HER2, TNBC
tests negative for all three.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font><font style="color: #000000">&#xA0;Due
to its aggressive nature and absence of common breast cancer
receptors, TNBC is characteristically difficult to
treat.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font><font style="color: #000000">&#xA0;For
patients with metastatic disease with PD-L1 expressing tumours, the
addition of immunotherapy to chemotherapy has improved outcomes in
the 1st-line setting.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10,11</font><font style="color: #000000">&#xA0;However,
for the approximately 70% of patients with metastatic TNBC who are
not candidates for immunotherapy, chemotherapy remains the 1st-line
standard of care.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</font></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="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
TROP2 is a protein broadly expressed in several solid tumours
including TNBC.</font><font style="font-size: 70%; vertical-align: top; color: #000000">12</font><font style="color: #000000">&#xA0;TROP2
is associated with increased tumour progression and poor survival
in patients with breast cancer.</font><font style="font-size: 70%; vertical-align: top; color: #000000">13,14</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">
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
TROPION-Breast02</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">
TROPION-Breast02 is a global, multicentre, randomised, open-label
Phase III trial evaluating the efficacy and safety
of&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;versus investigator's choice of chemotherapy
(paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin)
in patients with previously untreated locally recurrent inoperable
or metastatic TNBC for whom immunotherapy was not an option. This
included patients whose tumours did not express PD-L1 as well as
patients with PD-L1 expressing tumours who could not receive
immunotherapy due to prior exposure in early-stage disease,
comorbidities or immunotherapy not being accessible in their
geography. Enrolment included patients with de novo or recurrent
disease, regardless of disease-free interval, and those with poor
prognostic factors such as brain metastases.</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">
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
The dual primary endpoints of TROPION-Breast02 are PFS as assessed
by blinded independent central review and OS. Key secondary
endpoints include PFS as assessed by investigator, objective
response rate, duration of response, disease control rate,
pharmacokinetics 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">
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia,
Europe, North America and South America. For more information,
visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">ClinicalTrials.gov</font><font style="color: #000000">.</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">
Datroway</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">
Datroway</font><font style="color: #000000">&#xA0;(datopotamab
deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a
TROP2-directed ADC. Designed using Daiichi Sankyo's proprietary DXd
ADC Technology,&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;is one of six DXd ADCs in the oncology
pipeline of Daiichi Sankyo, and one of the most advanced programmes
in AstraZeneca's ADC scientific platform.&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;is comprised of a humanised anti-TROP2 IgG1
monoclonal antibody, developed in collaboration with Sapporo
Medical University, attached to a number of topoisomerase I
inhibitor payloads (an exatecan derivative, DXd) via
tetrapeptide-based cleavable linkers.</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">
Datroway</font><font style="color: #000000">&#xA0;is approved in
more than 35 countries/regions worldwide for the treatment of adult
patients with unresectable or metastatic HR-positive, HER2-negative
(IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received
prior endocrine-based therapy and chemotherapy for unresectable or
metastatic disease based on results from
the&#xA0;</font><font style="text-decoration: underline; color: #0000FF">TROPION-Breast01</font><font style="color: #000000">&#xA0;trial.</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">
Datroway</font><font style="color: #000000">&#xA0;is available in
the US under accelerated approval for the treatment of adult
patients with locally advanced or
metastatic&#xA0;</font><font style="font-style: italic; color: #000000">EGFR</font><font style="color: #000000">-mutated non-small cell lung cancer (NSCLC) who
have received prior&#xA0;</font><font style="font-style: italic; color: #000000">EGFR</font><font style="color: #000000">-directed therapy and platinum-based chemotherapy
based on results from the&#xA0;</font><font style="text-decoration: underline; color: #0000FF">TROPION-Lung05</font><font style="color: #000000">&#xA0;and&#xA0;</font><font style="text-decoration: underline; color: #0000FF">TROPION-Lung01</font><font style="color: #000000">&#xA0;trials.
Continued approval for this indication in the US may be contingent
upon verification and description of clinical benefit in a
confirmatory trial.&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;is approved in Russia for the same
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="font-weight: bold; font-style: italic; color: #000000">
Datroway</font><font style="color: #000000">&#xA0;</font><font style="font-weight: bold; color: #000000">clinical 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 global clinical development programme&#xA0;is
underway with more than 20 trials evaluating the efficacy and
safety of&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;across multiple cancers, including NSCLC,
TNBC and urothelial cancer.&#xA0;The programme includes eight Phase
III trials in lung cancer and five Phase III trials in breast
cancer evaluating&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;as a monotherapy and in combination with
other anticancer treatments in various
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">
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<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">
AstraZeneca and Daiichi Sankyo 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;in&#xA0;</font><font style="text-decoration: underline; color: #0000FF">March
2019</font><font style="color: #000000">&#xA0;and&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#xA0;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 for each ADC. 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&#xA0;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="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; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca in breast cancer&#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">
Driven by a growing understanding of breast cancer biology,
AstraZeneca is challenging, and redefining, the current clinical
paradigm for how breast cancer is classified and treated to deliver
even more effective treatments to patients in need - with the bold
ambition to one day eliminate breast cancer as a cause of
death.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca has a comprehensive portfolio of approved and promising
compounds in development that leverage different mechanisms of
action to address the biologically diverse breast cancer tumour
environment.</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">
With&#x202F;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">, AstraZeneca and Daiichi Sankyo are aiming to
improve outcomes in previously treated HER2-positive, HER2-low and
HER2-ultralow metastatic breast cancer, and are exploring its
potential in earlier lines of treatment and in new breast cancer
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="color: #000000">
In HR-positive breast cancer, AstraZeneca continues to improve
outcomes with foundational medicines&#x202F;</font><font style="font-style: italic; color: #000000">Faslodex</font><font style="color: #000000">&#x202F;(fulvestrant) and&#x202F;</font><font style="font-style: italic; color: #000000">Zoladex</font><font style="color: #000000">&#x202F;(goserelin) and aims to reshape the
HR-positive space with first-in-class AKT
inhibitor,&#x202F;</font><font style="font-style: italic; color: #000000">Truqap</font><font style="color: #000000">&#x202F;(capivasertib), the TROP2-directed
ADC,&#x202F;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">, and next-generation oral SERD and potential new
medicine camizestrant.</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">
PARP inhibitor&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;(olaparib) is a targeted treatment option
that has been studied in early and metastatic breast cancer
patients with an inherited BRCA mutation. AstraZeneca with MSD
(Merck &amp; Co., Inc. in the US and Canada) continue to
research&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;in these settings. AstraZeneca is also
exploring the potential of saruparib, a potent and selective
inhibitor of PARP1, in combination with camizestrant in
BRCA-mutated, HR-positive, HER2-negative advanced breast
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">
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
To bring much-needed treatment options to patients with
triple-negative breast cancer, an aggressive form of breast cancer,
AstraZeneca is collaborating with Daiichi Sankyo to evaluate the
potential of&#x202F;</font><font style="font-style: italic; color: #000000">Datroway</font><font style="color: #000000">&#x202F;alone and in combination with
immunotherapy&#x202F;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">.&#x202F;</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca in oncology</font></div>
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<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>
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<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>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca has the vision to redefine cancer care 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>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal &amp; Metabolism, and Respiratory &amp;
Immunology. Based in Cambridge, UK, AstraZeneca's innovative
medicines are sold in more than 125 countries and used by millions
of patients worldwide. Please visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000">&#xA0;and
follow the Company on social media&#xA0;</font><font style="text-decoration: underline; color: #0000FF">@AstraZeneca</font><font style="color: #000000">.</font></font></div>
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For details on how to contact the Investor Relations Team, please
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References</font></div>
<div style="text-align: left; margin-left: 36px; margin-right: 0px; text-indent: -24px;">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">1.&#xA0;&#xA0;
Punie, et al. Unmet Need for Previously Untreated Metastatic
Triple-Negative Breast Cancer: a Real-World Study of Patients
Diagnosed from 2011 to 2022 in the United States. The Oncologist.
2025; 30(3): oyaf034.</font></div>
<div style="text-align: left; margin-left: 36px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">2.&#xA0;&#xA0; National
Comprehensive Cancer Network. Breast Cancer. (Version
3.2025).</font><font style="color: #000000">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.nccn.org/login?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">Accessed
October 2025.</font></font></div>
<div style="text-align: left; margin-left: 36px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">3.&#xA0;&#xA0;</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">O'Reilly D, et al. Overview of
Recent Advances in Metastatic Triple Negative Breast
Cancer.&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">World J Clin
Oncol</font><font style="color: #000000; font-size: 13px">.
2021;12(3):164-182.</font></font></div>
<div style="text-align: left; margin-left: 36px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">4.&#xA0;&#xA0;</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">World Health Organization. Breast
Cancer. Available at:</font><font style="color: #000000">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.who.int/news-room/fact-sheets/detail/breast-cancer</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">Accessed
October 2025.</font></font></div>
<div style="text-align: left; margin-left: 36px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">5.&#xA0;&#xA0;</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">American Cancer Society.
Triple-Negative Breast Cancer. Available at:</font><font style="color: #000000">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.cancer.org/cancer/types/breast-cancer/about/types-of-breast-cancer/triple-negative.html</font><font style="color: #000000; font-size: 13px">.</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">Accessed
October 2025.</font></font></div>
<div style="text-align: left; margin-left: 36px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">6.&#xA0;&#xA0; Martinez et al. Contribution of
Clinical and Socioeconomic Factors to Differences in Breast Cancer
Subtype and Mortality Between Hispanic and Non-Hispanic White
Women.&#xA0;</font><font style="font-style: italic; color: #000000">Breast Cancer Res
Treat</font><font style="color: #000000">. 2017;
166(1):185-193</font></font></div>
<div style="text-align: left; margin-left: 36px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">7.&#xA0;&#xA0;</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">Vargas et al. Risk Factors for
Triple-Negative Breast Cancer Among Latina
Women.&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Cancer
Epidemiol Biomarkers Prev</font><font style="color: #000000; font-size: 13px">&#xA0;(2019) 28 (11):
1771-1783.</font></font></div>
<div style="text-align: left; margin-left: 36px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">8.&#xA0;&#xA0;</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">National Cancer Institute. SEER
Cancer Stat Facts: Female Breast Cancer Subtypes. Available
at:</font><font style="color: #000000">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://seer.cancer.gov/statfacts/html/breast-subtypes.html</font><font style="color: #000000; font-size: 13px">.</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">Accessed
October 2025.</font></font></div>
<div style="text-align: left; margin-left: 36px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">9.&#xA0;&#xA0;</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">Sharma P, et al. Biology and
Management of Patients with Triple-Negative Breast
Cancer.&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Oncologist</font><font style="color: #000000; font-size: 13px">.
2016; 21(9): 1050-62.
10.1634/theoncologist.2016.0067.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">10.&#xA0; Cortes J, et al. Pembrolizumab Plus
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2022;387:217-226.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">11.&#xA0; Geurts V, et al. Immunotherapy for
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">12.&#xA0; Rossi V, et
al.</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">Sacituzumab Govitecan in
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Aug;15: 1447280.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">13.&#xA0; Lin H, et al. Significantly upregulated
TACSTD2 and Cyclin D1 Correlate with Poor Prognosis of Invasive
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73-78.</font></font></div>
<div style="text-align: left; margin-left: 36px; margin-right: 0px; text-indent: -24px;">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">14.&#xA0;</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">Goldenberg D, et al. The
Emergence of Trophoblast Cell-Surface Antigen 2 (TROP-2) as a Novel
Cancer Target.</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px; background-color: #FFFFFF">Oncotarget.</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; font-size: 13px">2018;9(48):
28989-29006.</font></font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Matthew Bowden</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Company Secretary</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca PLC</font></div>
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SIGNATURES</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-size: 13px">
Date:</font> 06 October 2025</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Matthew Bowden</font></div>
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Name:
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<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Title:
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