<SEC-DOCUMENT>0001654954-25-013450.txt : 20251126
<SEC-HEADER>0001654954-25-013450.hdr.sgml : 20251126
<ACCEPTANCE-DATETIME>20251126062706
ACCESSION NUMBER:		0001654954-25-013450
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20251126
FILED AS OF DATE:		20251126
DATE AS OF CHANGE:		20251126

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:		251523793

	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>a9865i.htm
<DESCRIPTION>IMFINZI APPROVED IN US FOR EARLY GASTRIC CANCER
<TEXT>
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<font style="font-family: Times New Roman; font-size: 13px">INDEX
TO EXHIBITS</font></div>
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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">
Imfinzi approved in US for early gastric cancer</font></div>
</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-style: italic; color: #000000; font-family: Times New Roman">
&#xA0;</font><font style="color: #000000">26 November
2025</font></font></div>
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&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 16px"><font style="font-weight: bold; font-style: italic; color: #000000">
Imfinzi</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; color: #000000">approved
in the US as first and only perioperative immunotherapy for
patients with</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; color: #000000">early
gastric and gastroesophageal cancers</font></font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;Based on MATTERHORN Phase III trial results which showed a
29% reduction in the risk of progression, recurrence or death and a
22% reduction in the risk of death for the Imfinzi regimen vs.
chemotherapy 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>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">
AstraZeneca's&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Imfinzi</font><font style="color: #000000; font-size: 13px">&#xA0;(durvalumab)</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">in
combination with standard-of-care FLOT chemotherapy (fluorouracil,
leucovorin, oxaliplatin, and docetaxel)</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">has
been approved in the US for the treatment of adult
patients</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">with
resectable, early-stage and locally advanced (Stages II, III, IVA)
gastric and gastroesophageal junction (GEJ) cancers. The approved
regimen includes neoadjuvant&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Imfinzi</font><font style="color: #000000; font-size: 13px">&#xA0;in
combination with chemotherapy before surgery, followed by
adjuvant&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Imfinzi</font><font style="color: #000000; font-size: 13px">&#xA0;in
combination with chemotherapy, then&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Imfinzi</font><font style="color: #000000; font-size: 13px">&#xA0;monotherapy.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">
The approval follows</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">Priority
Review</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">by
the Food and Drug Administration (FDA) and is based on event-free
survival (EFS) and overall survival (OS) data from the MATTERHORN
Phase III trial</font><font style="font-style: italic; color: #000000; font-size: 13px">.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">The
EFS results were presented&#xA0;during the Plenary Session at the
2025 American Society of Clinical Oncology (ASCO) Annual Meeting
and simultaneously published in</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF; font-size: 13px">The
New England Journal of Medicine</font><font style="font-style: italic; color: #000000; font-size: 13px">.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">OS
results from MATTERHORN were presented&#xA0;in a Proffered Paper
session at the European Society for Medical Oncology (ESMO)
Congress 2025.</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">
Gastric cancer is the fifth leading cause of cancer death globally,
with nearly one million people diagnosed each
year.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;In
2024, there were roughly 6,500 drug-treated patients in the US in
early-stage and locally advanced gastric or GEJ
cancer.</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="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">
Dave Fredrickson, Executive Vice President,
Oncology</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Haematology</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Business
Unit, AstraZeneca, said:&#xA0;"This approval ushers in a new
clinical paradigm for patients with early gastric and
gastroesophageal junction cancers, with&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Imfinzi</font><font style="color: #000000; font-size: 13px">&#xA0;plus
FLOT delivering a durable survival benefit that increases over
time. As the third US approval for a
perioperative&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Imfinzi</font><font style="color: #000000; font-size: 13px">-based
regimen, this milestone further validates the perioperative
approach and underscores our focus on bringing novel treatments to
early-stage cancers where cure is the goal."</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: 16px"><font style="color: #000000; font-size: 13px">
Yelena Y. Janjigian, MD, Chief Attending Physician of the
Gastrointestinal Medical Oncology Service, Memorial Sloan Kettering
Cancer Center (MSK), New York and principal investigator in the
MATTERHORN trial, said: "Today's approval marks the first
immunotherapy regimen approved in the neoadjuvant setting for
gastric and gastroesophageal junction cancers-with durvalumab
demonstrating a clear overall survival benefit and opening an
entirely new chapter in the treatment of early-stage
disease.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">Nearly
seven in 10 patients were alive at three years following treatment
with the durvalumab-based perioperative regimen. This survival
benefit, observed regardless of PD-L1 status, establishes a new
standard of care in this curative-intent
setting."</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">
Aki Smith, Founder and Executive Director, Hope for Stomach Cancer,
said: "From personal experience as a caregiver to my father, I know
that for too long patients diagnosed with early gastric or
gastroesophageal junction cancer have faced a high risk of their
cancer returning, even after undergoing surgery and therapy
intended to cure it. Today's approval represents a major step
forward in improving outcomes and offering renewed hope to those
affected by this devastating disease."</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-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In a planned interim analysis, patients treated with
the&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">-based perioperative regimen showed a 29%
reduction in the risk of disease progression, recurrence or death
versus chemotherapy alone (based on an EFS hazard ratio [HR] of
0.71; 95% confidence interval [CI] 0.58-0.86; p&lt;0.001).
Estimated median EFS was not yet reached for
the&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;arm versus 32.8 months for the comparator
arm. An estimated 78.2% of patients treated with
the&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">-based perioperative regimen were event-free at
one year, compared to 74.0% in the comparator arm; the estimated
24-month EFS rate was 67.4% versus 58.5%,
respectively.</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 the final OS analysis, results showed
the&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;and FLOT perioperative regimen reduced the
risk of death by 22% compared with chemotherapy alone (based on a
HR of 0.78; 95% CI 0.63-0.96; p=0.021). An estimated 69% of
patients treated with the&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">-based regimen were alive at three years compared
with 62% in the FLOT-only arm. With longer follow-up, the OS curves
showed continued separation, signaling a greater magnitude of
benefit over time for the&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">-based regimen. An OS benefit was observed
regardless of PD-L1 status.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The safety profile for&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;and FLOT chemotherapy was consistent with
the known profiles of each medicine, and the percentage of patients
that completed surgery was similar compared to chemotherapy alone.
Grade 3 or higher adverse events due to any cause were similar
between the two arms (71.6% for&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;and FLOT arm; 71.2% for FLOT-only
arm).</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The 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, the&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;and FLOT perioperative regimen is also under
review by regulatory authorities in Australia, Canada, and
Switzerland for the same indication. Regulatory applications are
also under review in the European Union (EU), Japan and several
other countries.</font></font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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<font style="text-decoration: underline; color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Notes</font></div>
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<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">
Gastric and gastroesophageal junction cancers</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Gastric (stomach) cancer is the fifth most common cancer worldwide
and the fifth-highest leading cause of cancer
mortality.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;Nearly
one million new patients were diagnosed with gastric cancer in
2022, with approximately 660,000 deaths reported
globally.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;In
many regions, its incidence has been increasing in patients younger
than 50 years old, along with other gastrointestinal (GI)
malignancies.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">In
2024, there were roughly 43,000 drug-treated patients in the US, EU
and Japan in early-stage and locally advanced gastric or GEJ
cancer.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;Approximately
62,000 patients in these regions are expected to be newly diagnosed
in this setting by 2030.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4</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="color: #000000">
GEJ cancer is a type of gastric cancer that arises from and spans
the area where the oesophagus connects to the
stomach.</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">
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<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">
Disease recurrence is common in patients with resectable gastric
cancer despite undergoing surgery with curative intent and
treatment with neoadjuvant/adjuvant
chemotherapy.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font><font style="color: #000000">&#xA0;Approximately
one in four patients with gastric cancer who undergo surgery
develop recurrent disease within one year, and the five-year
survival rate remains poor, with less than half of patients alive
at five years.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6-7</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">
MATTERHORN</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">
MATTERHORN is a randomised, double-blind, placebo-controlled,
multi-centre, global Phase III trial
evaluating&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;as perioperative treatment for patients with
resectable Stage II-IVA gastric and GEJ cancers. Perioperative
therapy includes treatment before and after surgery, also known as
neoadjuvant/adjuvant therapy. In the trial, 948 patients were
randomised to receive a 1500mg fixed dose
of&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;plus FLOT chemotherapy or placebo plus FLOT
chemotherapy every four weeks for two cycles prior to surgery. This
was followed by&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;or placebo every four weeks for up to 12
cycles after surgery (including two cycles
of&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;or placebo plus FLOT chemotherapy and 10
additional cycles of&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;or placebo monotherapy).</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
In the MATTERHORN trial, the primary endpoint is EFS, defined as
time from randomisation until the date of one of the following
events (whichever occurred first): RECIST (version 1.1, per blinded
independent central review assessment) progression that precludes
surgery or requires non-protocol therapy during the neoadjuvant
period; RECIST progression/recurrence during the adjuvant period;
non-RECIST progression that precludes surgery or requires
non-protocol therapy during the neoadjuvant period or discovered
during surgery; progression/recurrence confirmed by biopsy
post-surgery; or death due to any cause. Key secondary endpoints
include pathologic complete response rate, defined as the
proportion of patients who have no detectable cancer cells in
resected tumour tissue following neoadjuvant therapy, and OS. The
trial enrolled participants in 176 centres in 20 countries,
including in the US, Canada, Europe, South America and
Asia.</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Imfinzi</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Imfinzi</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">(durvalumab)
is a human monoclonal antibody that binds to the PD-L1 protein and
blocks the interaction of PD-L1 with the PD-1 and CD80 proteins,
countering the tumour's immune-evading tactics and releasing the
inhibition of immune responses.</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 GI cancer,&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is approved in combination with chemotherapy
in locally advanced or metastatic biliary tract cancer (BTC) and in
combination with&#xA0;</font><font style="font-style: italic; color: #000000">Imjudo</font><font style="color: #000000">&#xA0;(tremelimumab) in unresectable
hepatocellular carcinoma (HCC).&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is also approved as a monotherapy in
unresectable HCC in Japan and the EU.&#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">
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In addition to its indications in GI
cancers,&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is the global standard of care based on OS
in the curative-intent setting of unresectable, Stage III non-small
cell lung cancer (NSCLC) in patients whose disease has not
progressed after chemoradiotherapy (CRT).
Additionally,&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is approved as a perioperative treatment in
combination with neoadjuvant chemotherapy in resectable NSCLC, and
in combination with a short course of&#xA0;</font><font style="font-style: italic; color: #000000">Imjudo</font><font style="color: #000000">&#xA0;and chemotherapy for the treatment of
metastatic NSCLC.&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is also approved for limited-stage small
cell lung cancer (SCLC) in patients whose disease has not
progressed following concurrent platinum-based CRT; and in
combination with chemotherapy for the treatment of extensive-stage
SCLC.</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">
Perioperative&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;in combination with neoadjuvant chemotherapy
is approved in the US, EU, Japan and other countries for patients
with muscle-invasive bladder cancer based on results from the
NIAGARA Phase III trial. Additionally, in May
2025,&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;added to Bacillus Calmette-Gu&#xE9;rin
induction and maintenance therapy met the primary endpoint of
disease-free survival for patients with high-risk
non-muscle-invasive bladder cancer in the POTOMAC Phase III
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">
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<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Imfinzi</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">in
combination with chemotherapy followed by&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;monotherapy is approved as a 1st-line
treatment for primary advanced or recurrent endometrial cancer
(mismatch repair deficient disease only in the US and
EU).&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;in combination with chemotherapy followed
by&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;(olaparib) and&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is approved for patients with mismatch
repair proficient advanced or recurrent endometrial cancer in the
EU and Japan.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Since the first approval in May 2017, more than 414,000 patients
have been treated with&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">. As part of a broad development
programme,&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is being tested as a single treatment and in
combinations with other anti-cancer treatments for patients with
NSCLC, bladder cancer, breast cancer, ovarian cancer and several GI
cancers.</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 GI cancers</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca has a broad development programme for the treatment of
GI cancers across several medicines and a variety of tumour types
and stages of disease. In 2022, GI cancers collectively represented
approximately 5 million new cancer cases leading to approximately
3.3 million deaths.</font><font style="font-size: 70%; vertical-align: top; color: #000000">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="color: #000000; font-family: Times New Roman; font-size: 13px">
Within this programme, the Company is committed to improving
outcomes in gastric, liver, biliary tract, oesophageal, pancreatic,
and colorectal cancers.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In addition to its indications in BTC and
HCC,&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is being assessed in combinations, including
with&#xA0;</font><font style="font-style: italic; color: #000000">Imjudo</font><font style="color: #000000">, in liver, oesophageal and gastric cancers in an
extensive development programme spanning early to late-stage
disease across settings.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Enhertu</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">(trastuzumab
deruxtecan), a HER2-directed antibody drug conjugate (ADC), is
approved in the US and several other countries for HER2-positive
advanced gastric cancer.&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;is jointly developed and commercialised by
AstraZeneca and Daiichi Sankyo.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Lynparza</font><font style="color: #000000">, a first-in-class PARP
inhibitor, is approved in the US and several other countries for
the treatment of BRCA-mutated metastatic pancreatic
cancer.&#xA0;</font><font style="font-style: italic; color: #000000">Lynparza</font><font style="color: #000000">&#xA0;is developed and commercialised in
collaboration with MSD (Merck &amp; Co., Inc. inside the US and
Canada).</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 Company is also assessing rilvegostomig (AZD2936), a PD-1/TIGIT
bispecific antibody, in combination with chemotherapy as an
adjuvant therapy in BTC, in combination with bevacizumab with or
without&#xA0;</font><font style="font-style: italic; color: #000000">Imjudo</font><font style="color: #000000">&#xA0;as a 1st-line treatment in patients with
advanced HCC, and as a 1st-line treatment in patients with
HER2-negative, locally advanced unresectable or metastatic gastric
and GEJ cancers. Rilvegostomig is also being evaluated in
combination with&#xA0;</font><font style="font-style: italic; color: #000000">Enhertu</font><font style="color: #000000">&#xA0;in previously untreated, HER2-expressing,
locally advanced or metastatic BTC.</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">
AstraZeneca is advancing multiple modalities that provide
complementary mechanisms for targeting Claudin 18.2, a promising
therapeutic target in gastric cancer. These include sonesitatug
vedotin, a potential first-in-class ADC licensed from KYM
Biosciences Inc., currently in Phase III development; AZD5863, a
novel Claudin 18.2/CD3 T-cell engager bispecific antibody licensed
from Harbour Biomed in Phase I development; and AZD4360, an
antibody drug conjugate, currently being evaluated in a Phase I/II
trial in patients with advanced solid tumours.</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">
In early development, AstraZeneca is developing C-CAR031 / AZD7003,
a Glypican 3 (GPC3) armoured CAR T, in HCC. C-CAR031 / AZD7003is
being co-developed with AbelZeta in China where it is under
evaluation in an IIT.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca in immuno-oncology (IO)</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 a pioneer in introducing the concept of
immunotherapy into dedicated clinical areas of high unmet medical
need. The Company has a comprehensive and diverse IO portfolio and
pipeline anchored in immunotherapies designed to overcome evasion
of the anti-tumour immune response and stimulate the body's immune
system to attack tumours.</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 strives to redefine cancer care and help transform
outcomes for patients with&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;as a monotherapy and in combination
with&#xA0;</font><font style="font-style: italic; color: #000000">Imjudo</font><font style="color: #000000">&#xA0;as well as other novel immunotherapies and
modalities. The Company is also investigating next-generation
immunotherapies like bispecific antibodies and therapeutics that
harness different aspects of immunity to target cancer, including
cell therapy and T-cell engagers.</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">
AstraZeneca is pursuing an innovative clinical strategy to bring
IO-based therapies that deliver long-term survival to new settings
across a wide range of cancer types. The Company is focused on
exploring novel combination approaches to help prevent treatment
resistance and drive longer immune responses. With an extensive
clinical programme, the Company also champions the use of IO
treatment in earlier disease stages, where there is the greatest
potential for cure.</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; color: #000000">
AstraZeneca in</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; text-decoration: underline; color: #0000FF">oncology</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">
AstraZeneca is leading a revolution in oncology with the ambition
to provide cures for cancer in every form, following the science to
understand cancer and all its complexities to discover, develop and
deliver life-changing medicines to patients.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
The Company's focus is on some of the most challenging cancers. It
is through persistent innovation that AstraZeneca has built one of
the most diverse portfolios and pipelines in the industry, with the
potential to catalyse changes in the practice of medicine and
transform the patient experience.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="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">
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AstraZeneca has the vision to redefine cancer care and, one day,
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AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
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medicines are sold in more than 125 countries and used by millions
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Contacts</font></div>
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References</font></div>
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<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">1.&#xA0;&#xA0; World Health
Organization. International Agency for Research on Cancer. Stomach
Fact Sheet. Available at:</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">https://gco.iarc.who.int/media/globocan/factsheets/cancers/7-stomach-fact-sheet.pdf.
Accessed November 2025.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">2.&#xA0;&#xA0; AstraZeneca PLC.
Investor Relations Epidemiology Spreadsheet. 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 November 2025.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">3.&#xA0;&#xA0; Li Y, et al. Global burden of
young-onset gastric cancer: a systematic trend analysis of the
global burden of disease study 2019.&#xA0;</font><font style="font-style: italic; color: #000000">Gastric
Cancer</font><font style="color: #000000">.
2024;27(4):684-700.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">4.&#xA0;&#xA0;
Kantar Health, validated with SEER stage at diagnosis and Cabasag
et al. And Kuzuu et al. 2021.</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: 16px"><font style="color: #000000; font-size: 13px">5.&#xA0;&#xA0; National Cancer
Institute. Gastroesophageal junction. Available
at:</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gastroesophageal-junction.
Accessed November 2025.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">6.&#xA0;&#xA0; Li Y, et al. Postoperative
recurrence of gastric cancer depends on whether the chemotherapy
cycle was more than 9 cycles.&#xA0;</font><font style="font-style: italic; color: #000000">Medicine</font><font style="color: #000000">. 2022;101(5):e28620.</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">7.&#xA0;&#xA0; Ilic M, Ilic I. Epidemiology of
stomach cancer.&#xA0;</font><font style="font-style: italic; color: #000000">World J
Gastroenterol</font><font style="color: #000000">.
2022;28(12):1187-1203.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 16px"><font style="color: #000000; font-size: 13px">8.&#xA0;&#xA0; World Health
Organization. World Cancer Fact Sheet. Available
at:</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf.
Accessed November 2025.</font></font></div>
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MSK Disclosure: Dr. Janjigian provides consulting and advisory
services to AstraZeneca.</font></div>
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Matthew Bowden</font></div>
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Company Secretary</font></div>
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AstraZeneca PLC</font></div>
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SIGNATURES</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
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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Date:</font> 26 November 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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<font style="font-family: Times New Roman; font-size: 13px">Name:
Matthew Bowden</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
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