<SEC-DOCUMENT>0001654954-25-000518.txt : 20250117
<SEC-HEADER>0001654954-25-000518.hdr.sgml : 20250117
<ACCEPTANCE-DATETIME>20250117071320
ACCESSION NUMBER:		0001654954-25-000518
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20250117
FILED AS OF DATE:		20250117
DATE AS OF CHANGE:		20250117

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		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:		25537003

	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>a7490t.htm
<DESCRIPTION>CALQUENCE COMBINATION APPROVED IN US FOR 1L MCL
<TEXT>
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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">
Calquence combination approved in US for 1L MCL</font></div>
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</font></div>
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<font style="font-family: Times New Roman; font-size: 13px;">&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
17 January 2025</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">
Calquence</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; color: #000000">plus
chemoimmunotherapy</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; color: #000000">approved
in the US for</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
patients with previously untreated mantle cell
lymphoma</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: 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">
Based on ECHO Phase III trial results which showed more than 16
months of progression-free survival improvement vs.
chemoimmunotherapy alone</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
First and only BTK inhibitor approved for the 1st-line treatment of
MCL in the US</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca's&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;(acalabrutinib) in combination with
bendamustine and rituximab has been approved in the US for the
treatment of adult patients with previously untreated mantle cell
lymphoma (MCL) who are ineligible for autologous hematopoietic stem
cell transplantation.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The approval was granted by the Food and Drug Administration (FDA)
after securing&#xA0;</font><font style="text-decoration: underline; color: #0000FF">Priority
Review</font><font style="color: #000000">. It was based on results
from the ECHO Phase III trial which were presented at the European
Hematology Association 2024 Congress.</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">
MCL is a rare and typically aggressive form of non-Hodgkin lymphoma
(NHL), often diagnosed at an advanced stage.</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[1]</font><font style="font-size: 70%; vertical-align: top; color: #000000">,</font><a name="_ednref2"><!--anchor--></a><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[2]</font><font style="color: #000000">&#xA0;It
is estimated that there are more than 21,000 patients diagnosed
with MCL in the US, UK, France, Germany, Spain, Italy, Japan and
China.</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[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="color: #000000; font-family: Times New Roman; font-size: 13px">
Michael Wang, MD, Puddin Clarke Endowed Professor, Director of
Mantle Cell Lymphoma Program of Excellence and principal
investigator in the trial, said: "Managing this aggressive cancer
requires maximising efficacy while maintaining tolerability,
especially for elderly patients. Results from the pivotal ECHO
trial highlight the promise of the acalabrutinib combination in
defining a new standard of care, with today's approval underscoring
the transformative potential of this regimen as a first-line
treatment for older patients with mantle cell
lymphoma."</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 Haematology
Business Unit, AstraZeneca, said: "With today's
approval,&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;provides a critical new treatment option to
mantle cell lymphoma patients in the US,
with&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;proven to deliver nearly one and a half
years of additional time without disease progression. This approval
brings a new and effective treatment option to those living with
this disease and further reinforces our belief
in&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;as a backbone therapy across multiple blood
cancers."&#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="color: #000000; font-family: Times New Roman; font-size: 13px">
Meghan Gutierrez, Chief Executive Officer, Lymphoma Research
Foundation, said: "New treatment options have long been needed in
the first-line treatment of mantle cell lymphoma in the US.
Patients with this rare and often aggressive cancer can experience
severe symptoms by the time they are diagnosed - having an
effective therapy that can significantly improve outcomes for
patients early in the treatment process is a much-needed
advancement."</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 ECHO trial showed&#xA0;</font><font style="font-style: italic; color: #000000">Calquence&#xA0;</font><font style="color: #000000">plus
bendamustine and rituximab reduced the risk of disease progression
or death by 27% compared to standard-of-care chemoimmunotherapy
(hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94;
p=0.016). Median PFS was 66.4 months for patients treated with
the&#xA0;</font><font style="font-style: italic; color: #000000">Calquence&#xA0;</font><font style="color: #000000">combination
versus 49.6 months with chemoimmunotherapy
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="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
This approval additionally converts&#xA0;</font><font style="font-style: italic; color: #000000">Calquence's</font><font style="color: #000000">&#xA0;accelerated approval to a full approval for
adult patients with MCL treated with at least one prior therapy, as
granted by the FDA in October 2017.</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 ECHO trial enrolled patients throughout the COVID-19 pandemic.
After censoring for COVID-19 deaths, PFS was further improved in
both arms, with the&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;combination reducing the risk of disease
progression or death by 36% (HR 0.64; 95% CI 0.48-0.84). Although
OS data were not mature at the time of the analysis, when censored
for COVID-19, a favourable trend was seen for OS (HR 0.75; 95% CI
0.53-1.04), despite 69% of patients in the chemoimmunotherapy arm
receiving treatment with a BTK inhibitor on relapse or disease
progression.</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 and tolerability of&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;was consistent with its known safety
profile, and no new safety signals were
identified.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The US regulatory submission was reviewed under Project Orbis,
which provides a framework for concurrent submission and review of
oncology medicines among participating international partners. As
part of Project Orbis,&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;plus chemoimmunotherapy is also under review
by regulatory authorities in Australia, Canada, and Switzerland for
the same indication. Regulatory applications are also under review
in the EU, Japan, and other countries based on the ECHO
results.</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="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Mantle cell lymphoma (MCL)</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 MCL patients initially respond to treatment, patients do tend
to relapse.</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[4]</font><font style="color: #000000">&#xA0;MCL
comprises about 3-6% of non-Hodgkin lymphomas, with an annual
incidence of 0.5 per 100,000 population in Western countries; in
the US, it is estimated that approximately 4,000 new patients are
diagnosed with MCL each year.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4,</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[5]</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">
ECHO</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">
ECHO is a randomised, double-blind, placebo-controlled,
multi-centre Phase III trial evaluating the efficacy and safety
of&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;plus bendamustine and rituximab compared to
SoC chemoimmunotherapy (bendamustine and rituximab) in adult
patients at or over 65 years of age (n=635) with previously
untreated MCL.</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[6]</font><font style="color: #000000">&#xA0;Patients
were randomised 1:1 to receive either&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;or placebo administered orally twice per
day, continuously, until disease progression or unacceptable
toxicity. Additionally, all patients received six 28-day cycles of
bendamustine on days 1 and 2 and rituximab on day 1 of each cycle,
followed by rituximab maintenance for two years if patients
achieved a response after induction therapy.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The primary endpoint is PFS assessed by an Independent Review
Committee; other efficacy endpoints include OS, overall response
rate (ORR), duration of response (DoR) and time to response
(TTR).</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font><font style="color: #000000">&#xA0;The
trial was conducted in 27 countries across North and South America,
Europe, Asia and Oceania.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The ECHO trial enrolled patients from May 2017 to March 2023,
continuing through the COVID-19 pandemic. Prespecified PFS and OS
analyses censoring for COVID-19 deaths were conducted to assess the
impact of COVID-19 on the study outcome in alignment with the FDA.
Patients with blood cancer remain at a disproportionately high risk
of severe outcomes from COVID-19, including hospitalisation and
death compared to the general population.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6,</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[7]</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Calquence</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">
Calquence</font><font style="color: #000000">&#xA0;(acalabrutinib)
is a second-generation, selective inhibitor of Bruton's tyrosine
kinase (BTK).&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;binds covalently to BTK, thereby inhibiting
its activity.</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[8]</font><font style="color: #000000">&#xA0;In
B-cells, BTK signalling results in activation of pathways necessary
for B-cell proliferation, trafficking, chemotaxis and
adhesion.</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">
Calquence</font><font style="color: #000000">&#xA0;has been used to
treat more than 85,000 patients worldwide</font><font style="font-size: 70%; vertical-align: top; text-decoration: underline; color: #0000FF">[9]</font><font style="color: #000000">&#xA0;and
is approved for the treatment of chronic lymphocytic leukaemia
(CLL) and small lymphocytic lymphoma (SLL) in the US and Japan,
approved for CLL in the EU and many other countries worldwide and
approved in China for relapsed or refractory CLL and
SLL.&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;is also approved for the treatment of adult
patients with previously untreated MCL in the US, and in China and
several other countries for the treatment of adult patients with
mantle cell lymphoma (MCL) who have received at least one prior
therapy.&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;is not currently approved for the treatment
of MCL in Japan or the EU.</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; background-color: #FFFFFF">
As part of an extensive clinical development
programme,&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Calquence</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;is
currently being evaluated as a single treatment and in combination
with standard-of-care chemoimmunotherapy for patients with multiple
B-cell blood cancers, including CLL, MCL and diffuse large B-cell
lymphoma.</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca in haematology</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 pushing the boundaries of science to redefine care
in haematology. Our goal is to help transform the lives of patients
living with malignant, rare and other related haematologic diseases
through innovative medicines and approaches that are shaped by
insights from patients, caregivers and
physicians.&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
In addition to our marketed products, we are spearheading the
development of novel therapies designed to target underlying
drivers of disease across multiple scientific platforms. Our
acquisitions of Alexion, with expertise in rare, non-malignant
blood disorders, and Gracell Biotechnologies Inc., pioneers of
autologous cell therapies, expand our haematology pipeline and
enable us to reach more patients with high unmet needs through the
end-to-end discovery, development and delivery of novel
therapies.</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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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: #000000">@</font><font style="text-decoration: underline; color: #0000FF">AstraZeneca</font><font style="color: #000000">.</font></font></div>
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Contacts</font></div>
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For details on how to contact the Investor Relations Team, please
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For Media contacts, click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.</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; font-size: 13px">1.&#xA0;&#xA0;&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Lymphoma
Research Foundation. Mantle Cell Lymphoma. Available at:
https://lymphoma.org/aboutlymphoma/nhl/mcl/. Accessed January
2025.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">2.&#xA0;&#xA0;&#xA0;&#xA0;
National Organization for Rare Disorders. Mantle Cell Lymphoma.
Available at:
https://rarediseases.org/rare-diseases/mantle-cell-lymphoma/.
Accessed January 2025.</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; font-size: 13px">3.&#xA0;&#xA0;&#xA0;&#xA0;
AstraZeneca 2024. Q3 2024 Financial Results. Available
at:</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.astrazeneca.com/investor-relations.html</font><font style="color: #000000; font-size: 13px">.
Accessed January 2025.</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"><font style="color: #000000; font-size: 13px">4.&#xA0;&#xA0;&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Cheah
C, Seymour J, Wang ML. Mantle cell
lymphoma.&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">J Clin
Oncol</font><font style="color: #000000; font-size: 13px">.
2016;34(11):1256-1269. doi:
10.1200/JCO.2015.63.5904.</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"><font style="color: #000000; font-size: 13px">5.&#xA0;&#xA0;&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">MD
Anderson Cancer Center. What to know about mantle cell lymphoma.
Available at:
https://www.mdanderson.org/cancerwise/what-to-know-about-mantle-cell-lymphoma-symptoms-diagnosis-and-treatment.h00-159385101.html.
Accessed January 2025.</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"><font style="color: #000000; font-size: 13px">6.&#xA0;&#xA0;&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">ClinicalTrials.gov.
A Study of BR Alone Versus in Combination With Acalabrutinib in
Subjects With Previously Untreated MCL. Available at:
https://clinicaltrials.gov/study/NCT02972840. Accessed January
2025.</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"><font style="color: #000000; font-size: 13px">7.&#xA0;&#xA0;&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Dube
S, et al. Continued Increased Risk of COVID-19 Hospitalisation and
Death in Immunocompromised Individuals Despite Receipt of &#x2265;4
Vaccine Doses: Updated 2023 Results from INFORM, a Retrospective
Health Database Study in England. Poster P0409 at ECCMID
2024.</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"><font style="color: #000000">8.&#xA0;&#xA0;&#xA0;&#xA0; Wu J, Zhang M, Liu D.
Acalabrutinib (ACP-196): a selective second-generation BTK
inhibitor.&#xA0;</font><font style="font-style: italic; color: #000000">J Hematol
Oncol</font><font style="color: #000000">.
2016;9(21).</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"><font style="color: #000000; font-size: 13px">9.&#xA0;&#xA0;&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Data
on File, REF-236261. AstraZeneca Pharmaceuticals
LP.</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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&#xA0;</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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<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">Date:
17 January 2025</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">By: /s/
Adrian Kemp</font></div>
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</tr><tr>
<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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<font style="font-family: Times New Roman; font-size: 13px">Name:
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<div><font style="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">Title:
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