<SEC-DOCUMENT>0001654954-26-004226.txt : 20260501
<SEC-HEADER>0001654954-26-004226.hdr.sgml : 20260501
<ACCEPTANCE-DATETIME>20260501084026
ACCESSION NUMBER:		0001654954-26-004226
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20260501
FILED AS OF DATE:		20260501
DATE AS OF CHANGE:		20260501

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:		26929135

	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>a7026c.htm
<DESCRIPTION>FDA ODAC RECOMMENDS TRUQAP IN PROSTATE CANCER
<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-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div><font style="font-family: Times New Roman; font-size: 13px">1.
FDA ODAC recommends Truqap in prostate cancer</font></div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row"></div>
</div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="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">
01 May 2026</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="font-style: italic; color: #000000">Truqap</font><font style="color: #000000">&#xA0;recommended by FDA Advisory Committee for
PTEN-deficient metastatic hormone-sensitive prostate
cancer</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center"><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font><font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">ODAC
overwhelming majority voted that Truqap plus abiraterone and ADT
demonstrated a favourable benefit risk profile for patients based
on the CAPItello-281 Phase III trial results</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
First and only targeted treatment combination to demonstrate
benefit in this subtype of prostate cancer addresses significant
unmet patient need</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="color: #000000">
The US Food and Drug Administration's (FDA) Oncologic Drugs
Advisory Committee (ODAC) has recognised a favourable benefit risk
profile for AstraZeneca's&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Truqap</font><font style="color: #000000">&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">(capivasertib)</font><font style="color: #000000">&#xA0;in
combination with abiraterone and androgen deprivation therapy (ADT)
for the treatment of patients with PTEN-deficient metastatic
hormone-sensitive prostate cancer (mHSPC), based on the
CAPItello-281 Phase III trial. The Committee voted 7 to 1, with 1
abstaining.</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;">&#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 August 2025, the FDA accepted the supplemental New Drug
Application (sNDA) for&#xA0;</font><font style="font-style: italic; color: #000000">Truqap</font><font style="color: #000000">&#xA0;in combination with abiraterone and ADT
based on positive results from the CAPItello-281 Phase III trial,
presented at the 2025 European Society for Medical Oncology (ESMO)
Congress and simultaneously published in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">Annals
of Oncology</font><font style="color: #000000; background-color: #FFFFFF">.</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FFFFFF">1</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">
Daniel George, MD, Director of Genitourinary Oncology at Duke
Cancer Institute and investigator for the trial, said: "Patients
identified to have PTEN-deficient metastatic hormone-sensitive
prostate cancer have an aggressive form of the disease and
currently experience&#xA0;poor outcomes. Their
disease&#xA0;significantly impacts their quality of life and
inevitably progresses&#xA0;to more advanced stages that are
associated with high mortality rates. In addition to this poor
prognosis,&#xA0;patients currently have&#xA0;limited treatment
options,&#xA0;which is why today's recommendation of the
capivasertib combination is welcome news for both patients and
clinicians to address an urgent need for new treatments that delay
progression."</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">
Susan Galbraith, Executive Vice President, Oncology Haematology
R&amp;D, AstraZeneca, said: "CAPItello-281 is the first pivotal
trial to prospectively define PTEN-deficient metastatic
hormone-sensitive prostate cancer and its severe course of disease.
The Committee's recognition of the unmet need in patients with
PTEN-deficiency and of the benefit seen with
the&#xA0;</font><font style="font-style: italic; color: #000000">Truqap</font><font style="color: #000000">&#xA0;combination verifies its potential to
address this significant need and optimise outcomes for
patients.&#xA0;We are committed to working closely with the FDA to
bring the first and only targeted treatment option to the one in
four patients with this form of metastatic hormone-sensitive
prostate 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">
Results from the primary analysis of the CAPItello-281 Phase III
trial showed a statistically significant 19% reduction in the risk
of radiographic disease progression or death and a clinically
meaningful improvement in median&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">radiographic
progression-free survival&#xA0;(</font><font style="color: #000000">rPFS) of 7.5 months with
the&#xA0;</font><font style="font-style: italic; color: #000000">Truqap</font><font style="color: #000000">&#xA0;combination versus treatment with
abiraterone and ADT with placebo (based on a hazard ratio [HR] of
0.81; 95% confidence interval [CI] 0.66-0.98; p=0.034). Median rPFS
was 33.2 months for the&#xA0;</font><font style="font-style: italic; color: #000000">Truqap</font><font style="color: #000000">&#xA0;combination versus 25.7 months for the
comparator arm.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</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">
A consistent benefit was observed with the&#xA0;</font><font style="font-style: italic; color: #000000">Truqap</font><font style="color: #000000">&#xA0;combination versus&#xA0;treatment with
abiraterone and ADT with placebo in key secondary endpoints of the
trial</font><font style="color: #000000; background-color: #FFFFFF">, including prolonged
time to castration resistance (29.5 vs. 22.0 months [HR 0.77; 95%
CI: 0.63-0.94]) and prostate-specific antigen (PSA) progression
(</font><font style="color: #000000">HR&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">0.73; 95% CI:
0.52-1.01), and fewer and delayed events in terms of symptomatic
skeletal event-free survival (SSE-FS) (42.5 vs. 37.3 months [HR
0.82, 95% CI: 0.66-1.02]).</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FFFFFF">1</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FFFFFF; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; background-color: #FFFFFF">
Overall survival (OS) data were immature at the time of primary
analysis; however, subsequent interim results for OS numerically
favoured the&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Truqap</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;combination
versus the comparator arm. The trial will continue as planned to
further assess OS as a key secondary endpoint.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FFFFFF; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; background-color: #FFFFFF">
The safety profile of&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Truqap</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;in
combination with abiraterone and ADT in CAPItello-281 was broadly
consistent with the known profile of each
medicine</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">.</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;Consistent
with the addition of a targeted treatment to background therapy,
Grade 3 or higher adverse events occurred in 67% of patients
treated with the&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Truqap</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;combination
versus 40.4% of patients treated with abiraterone and ADT with
placebo. The most common Grade 3 or higher adverse events in
the&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Truqap</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;arm
were rash (12.3%), hyperglycaemia (10.3%), hypokalaemia (8.7%),
diarrhoea (6.2%), hypertension (5.8%) and anaemia
(5.2%).</font><font style="font-size: 70%; vertical-align: top; color: #000000; background-color: #FFFFFF">1</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 ODAC provides the FDA with independent, expert advice and
recommendations on marketed and investigational medicines for use
in the treatment of cancer. The FDA will consider the feedback as
it reviews the submission and is not bound by the Committee's
recommendation.</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">
A regulatory application for&#xA0;</font><font style="font-style: italic; color: #000000">Truqap</font><font style="color: #000000">&#xA0;in combination with abiraterone and ADT for
the treatment of PTEN-deficient mHSPC is under review in the EU
based on the CAPItello-281 Phase III trial.</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: left; 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: 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="font-weight: bold; color: #000000">
Prostate cancer</font><font style="color: #000000">&#xA0;</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Prostate cancer is the second most prevalent cancer in men and the
fifth leading cause of male cancer death globally, with an
incidence of more than 1.4 million and approximately 397,000 deaths
in 2022.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;In
the US, prostate cancer is the most common cancer in men, with more
than 300,000 new cases of the disease diagnosed annually, and more
than 36,000 deaths.</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>
<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">
Metastatic prostate cancer is associated with a significant
mortality rate, with only one third of patients surviving five
years after diagnosis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4</font><font style="color: #000000">&#xA0;Development
of prostate cancer is often driven by male sex hormones called
androgens, including testosterone.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</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; background-color: #FFFFFF; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Metastatic hormone-sensitive prostate 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">
In patients with mHSPC, also known as metastatic
castration-sensitive prostate cancer (mCSPC), prostate cancer cells
need high levels of androgens to drive cancer
growth.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5,6</font><font style="color: #000000">&#xA0;Hormone
therapies, such as ADT, are widely used to block the action of male
sex hormones and lower the levels of androgens in the
body.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6,7</font><font style="color: #000000">&#xA0;However,
resistance to these therapies is common and there is a need to
extend their use to delay disease progression and castration
resistance, where the prostate cancer grows and spreads to other
parts of the body despite the use of these
therapies.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6-8</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">
Newly diagnosed mHSPC is an aggressive form of the disease
associated with poor outcomes and survival.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6,8</font><font style="color: #000000">&#xA0;Globally,
approximately 200,000 patients are diagnosed with mHSPC each year,
with 35,000 patients diagnosed with the disease in the
US.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9</font><font style="color: #000000">&#xA0;One
in four of these patients have PTEN-deficient
tumours.</font><font style="font-size: 70%; vertical-align: top; color: #000000">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">
PTEN-loss or deficiency fuels the growth of cancer cells, leading
to dysregulation of the PI3K/AKT pathway, and is associated with
poor outcomes in patients with prostate cancer.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10,11</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FFFFFF; font-weight: bold; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FFFFFF; font-weight: bold; font-family: Times New Roman; font-size: 13px">
CAPItello-281</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: #FFFFFF">
CAPItello-281 is a Phase III, double-blind, randomised trial
evaluating the efficacy and safety of&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Truqap</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;in
combination with abiraterone and ADT versus abiraterone and ADT in
combination with placebo in the treatment of patients with
PTEN-deficient&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">de
novo</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;mHSPC.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FFFFFF; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; background-color: #FFFFFF">
The global trial enrolled 1,012 adult patients with histologically
confirmed&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">de
novo</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;hormone-sensitive
prostate adenocarcinoma and PTEN deficiency as confirmed by central
testing. The primary endpoint of the CAPItello-281 trial is rPFS as
assessed by investigator, with OS as a secondary
endpoint.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="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">
Truqap</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">
Truqap</font><font style="color: #000000">&#xA0;is a
first-in-class, potent, adenosine triphosphate (ATP)-competitive
inhibitor of all three AKT isoforms (</font><font style="font-style: italic; color: #000000">AKT1/2/3</font><font style="color: #000000">).&#xA0;</font><font style="font-style: italic; color: #000000">Truqap</font><font style="color: #000000">&#xA0;400mg is administered twice daily according
to an intermittent dosing schedule of four days on and three days
off. This was chosen in early phase trials based on tolerability
and the degree of target inhibition.</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">
Truqap</font><font style="color: #000000">&#xA0;in combination
with&#xA0;</font><font style="font-style: italic; color: #000000">Faslodex</font><font style="color: #000000">&#xA0;(fulvestrant) is approved in the US, EU,
Japan, China and a number of other countries for the treatment of
adult patients with HR-positive (or estrogen receptor-positive),
HER2-negative locally advanced or metastatic breast cancer with one
or more biomarker alterations (</font><font style="font-style: italic; color: #000000">PIK3CA</font><font style="color: #000000">,&#xA0;</font><font style="font-style: italic; color: #000000">AKT1</font><font style="color: #000000">&#xA0;or&#xA0;</font><font style="font-style: italic; color: #000000">PTEN</font><font style="color: #000000">) following recurrence or progression on or after
an endocrine-based regimen based on the results from the
CAPItello-291 trial.&#xA0;</font><font style="font-style: italic; color: #000000">Truqap</font><font style="color: #000000">&#xA0;is also approved in Australia for the
treatment of adult patients with HR-positive, HER2-negative locally
advanced or metastatic breast cancer following recurrence or
progression on or after an endocrine based regimen based on these
trial results.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Truqap</font><font style="color: #000000">&#xA0;is currently being
evaluated in Phase III trials for the treatment of breast cancer
(CAPItello-292) and prostate cancer (CAPItello-281) in combination
with established treatments.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Truqap</font><font style="color: #000000">&#xA0;was discovered by
AstraZeneca subsequent to a collaboration with Astex Therapeutics
(and its collaboration with the Institute of Cancer Research and
Cancer Research Technology Limited).</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; color: #000000">
AstraZeneca in oncology</font><font style="color: #000000">&#xA0;</font></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.&#xA0;</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
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AstraZeneca has the vision to redefine cancer care and, one
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AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led
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development, and commercialisation of prescription medicines in
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References</font></div>
<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">1.&#xA0;&#xA0; Fizazi K, et al. Capivasertib plus
abiraterone in PTEN-deficient metastatic hormone sensitive prostate
cancer: CAPItello-281 phase III study.&#xA0;</font><font style="font-style: italic; color: #000000">Ann Oncol</font><font style="color: #000000">&#xA0;2026; 37(1):53-68.</font></font></div>
<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">2.&#xA0;&#xA0; Bray F, et al. Global cancer
statistics 2022: GLOBOCAN estimates of incidence and mortality
worldwide for 36 cancers in 185 countries.&#xA0;</font><font style="font-style: italic; color: #000000">CA Cancer J
Clin</font><font style="color: #000000">. 2024 Apr 4. doi:
10.3322/caac.21834.</font></font></div>
<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">3.&#xA0;&#xA0; American Cancer Society. Key
Statistics for Prostate cancer. Available
at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html</font><font style="color: #000000">.
Accessed April 2026.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">4.&#xA0;&#xA0;
Chowdhury S, et al. Real-World Outcomes in First-Line Treatment of
Metastatic Castration-Resistant Prostate Cancer: The Prostate
Cancer Registry. Target Oncol. 2020;15(3):301-315.</font></div>
<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">5.&#xA0;&#xA0; National Cancer Institute. Hormone
Therapy for Prostate Cancer Fact Sheet. Available
at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet</font><font style="color: #000000">.
Accessed April 2026.</font></font></div>
<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">6.&#xA0;&#xA0; American Society of Clinical
Oncology Educational Book. Metastatic Hormone-Sensitive Prostate
Cancer: Toward an Era of Adaptive and Personalized Treatment.
Available at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://ascopubs.org/doi/pdf/10.1200/EDBK_390166</font><font style="color: #000000">.
Accessed April 2026.</font></font></div>
<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">7.&#xA0;&#xA0; Cancer Research UK. Hormone therapy
for metastatic prostate cancer. Available
at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF">https://www.cancerresearchuk.org/about-cancer/prostate-cancer/metastatic-cancer/treatment/hormone-therapy-for-metastatic-prostate-cancer</font><font style="color: #000000">.
Accessed April 2026.</font></font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">8.&#xA0;&#xA0;
Hussain M, et al. Metastatic Hormone-Sensitive Prostate Cancer and
Combination Treatment Outcomes A Review. JAMA Oncol.
2024;10(6):807-820.</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">9.&#xA0;&#xA0;
Cerner CancerMPact database. Accessed April 2026.</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">10.&#xA0;
Cuzick J, et al. Prognostic value of PTEN loss in men with
conservatively managed localised prostate cancer. Br J Cancer.
2013;108(12):2582-2589.</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">11.&#xA0;
Gasmi A, et al. Overview of the Development and Use of Akt
Inhibitors in Prostate Cancer. J Clin Med.
2021;11(1):160.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
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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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