FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of July 2025
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi approved in the EU for bladder cancer
4 July 2025
Imfinzi approved in the EU as first and only
perioperative
immunotherapy for muscle-invasive bladder cancer
Approval based on NIAGARA Phase III trial results which showed a
32% reduction in the risk of recurrence and a 25% reduction in the
risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy
alone
AstraZeneca's Imfinzi (durvalumab) has been approved in the
European Union (EU) for the treatment of adult patients with
resectable muscle-invasive bladder cancer (MIBC) in combination
with gemcitabine and cisplatin as neoadjuvant treatment, followed
by Imfinzi as monotherapy adjuvant treatment after
radical cystectomy (surgery to remove the
bladder).
The approval by the European Commission follows
the positive
opinion of the Committee
for Medicinal Products for Human Use and is based on results from
the NIAGARA Phase
III trial, which were published in The
New England Journal of Medicine.
In a planned interim analysis, the Imfinzi-based perioperative regimen
demonstrated a statistically significant 32% reduction in the risk
of disease progression, recurrence, not undergoing surgery, or
death versus neoadjuvant chemotherapy with radical cystectomy alone
(based on event-free survival [EFS] hazard ratio [HR] of 0.68; 95%
confidence interval [CI] 0.56-0.82; p<0.0001). Estimated median
EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator
arm. An estimated 67.8% of patients treated with the regimen were
event free at two years compared to 59.8% in the comparator
arm.
Results from the key secondary endpoint of overall survival (OS)
showed that the Imfinzi-based perioperative regimen reduced the
risk of death by 25% versus the comparator arm (based on OS HR of
0.75; 95% CI 0.59-0.93; p=0.0106). Median survival was not yet
reached for either arm. An estimated 82.2% of patients treated with
the regimen were alive at two years compared to 75.2% in the
comparator arm.
In 2024, over 35,000 people in the five major European countries
were treated for MIBC.1 Despite
this representing a curative-intent setting, many patients
experience disease recurrence after surgery with current
standard-of-care neoadjuvant chemotherapy.2
Dr Michiel Van der Heijden, medical oncologist and Group Leader at
the Netherlands Cancer Institute, and investigator in the NIAGARA
trial, said: "The durvalumab-based perioperative regimen is an
important new treatment option for patients in Europe with
muscle-invasive bladder cancer, as currently nearly half experience
disease recurrence despite treatment with neoadjuvant chemotherapy
and surgery to remove the bladder. The NIAGARA results showed how
this regimen reduced the risk of recurrence by nearly a third and
significantly extended survival, underscoring its potential to
transform clinical practice in this curative-intent
setting."
Dave Fredrickson, Executive Vice President, Oncology Haematology
Business Unit, AstraZeneca, said: "Imfinzi is poised to transform the standard of care
for muscle-invasive bladder cancer in Europe as the first and only
perioperative immunotherapy for these patients. In the NIAGARA
Phase III trial, more than 80 per cent of patients were still alive
two years after treatment with the Imfinzi regimen, setting a new survival benchmark
for a disease that has seen few treatment advances in
decades."
Imfinzi was generally well
tolerated, and no new safety signals were observed in the
neoadjuvant and adjuvant settings. Further,
adding Imfinzi to neoadjuvant chemotherapy was consistent
with the known profile for this combination and did not compromise
patients' ability to complete surgery compared to neoadjuvant
chemotherapy alone. Immune-mediated adverse events were consistent
with the known profile of Imfinzi, manageable and mostly
low-grade.
The European Society for Medical Oncology (ESMO) has published its
assessment of the NIAGARA regimen against the Magnitude of Clinical
Benefit Scale (MCBS), awarding it the highest possible grade of "A"
in the curative setting.3 The
ESMO-MCBS facilitates improved decision-making regarding the value
of anti-cancer therapies and is used in several ways, including in
clinical guidelines and in health technology assessments in a
growing number of countries.4
Imfinzi is approved in the
US and other countries in
this setting based on the NIAGARA results. Regulatory applications
for this indication are currently under review in Japan and several
other countries. Imfinzi is also approved in other curative-intent
settings based on the PACIFIC and AEGEAN Phase III trials in
non-small cell lung cancer (NSCLC), and in limited-stage small cell
lung cancer (SCLC) based on the ADRIATIC Phase III
trial.
Notes
Muscle-invasive bladder cancer
Bladder cancer is the 9th most common cancer in the world, with
more than 614,000 patients diagnosed each year.5 The
most common type of bladder cancer is urothelial carcinoma, which
begins in the urothelial cells of the urinary
tract.6 Bladder
cancer is considered muscle-invasive when there is evidence of the
tumour invading the muscle wall of the bladder but no distant
metastases.6 In
MIBC, approximately 50% of patients who undergo bladder removal
surgery experience disease recurrence.2 Treatment
options that prevent disease recurrence after surgery are
critically needed in this curative-intent
setting.
NIAGARA
NIAGARA is a randomised, open-label, multi-centre, global Phase III
trial evaluating perioperative Imfinzi as treatment for patients with MIBC before
and after radical cystectomy. In the trial, 1,063 patients were
randomised to receive four cycles of Imfinzi plus
neoadjuvant chemotherapy prior to cystectomy followed by eight
cycles of Imfinzi monotherapy, or
neoadjuvant chemotherapy alone prior to cystectomy with no further
treatment after surgery. NIAGARA is the largest global Phase III
trial in this setting.
The trial is being conducted at 192 centres in 22 countries across
North America, South America, Europe, Australia and Asia. Its dual
primary endpoints are EFS and pathologic complete response at the
time of cystectomy. Key secondary endpoints are OS and
safety.
Imfinzi
Imfinzi (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.
In May 2025, Imfinzi plus standard-of-care Bacillus
Calmette-Guérin 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.
In lung cancer, Imfinzi is the global standard of care based on OS
in the curative-intent setting of unresectable, Stage III NSCLC in
patients whose disease has not progressed after chemoradiotherapy
(CRT). Additionally, Imfinzi is approved as a perioperative treatment in
combination with neoadjuvant chemotherapy in resectable NSCLC, and
in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the
treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage 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.
Imfinzi is also approved
in combination with chemotherapy in locally advanced or metastatic
biliary tract cancer and in combination
with Imjudo in unresectable hepatocellular carcinoma
(HCC). Imfinzi is also approved as a monotherapy in
unresectable HCC in Japan and the EU.
In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met
the primary endpoint of EFS in the MATTERHORN Phase III trial in
resectable gastric and gastroesophageal junction
cancers.
Imfinzi in combination
with chemotherapy followed by Imfinzi 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). Imfinzi in combination with chemotherapy followed
by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch
repair proficient advanced or recurrent endometrial cancer in the
EU and Japan.
Since the first approval in May 2017, more than 414,000 patients
have been treated with Imfinzi. As part of a broad development
programme, Imfinzi 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
gastrointestinal cancers.
AstraZeneca in immuno-oncology (IO)
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.
AstraZeneca strives to redefine cancer care and help transform
outcomes for patients with Imfinzi as a monotherapy and in combination
with Imjudo 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.
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.
AstraZeneca in oncology
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.
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.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
AstraZeneca
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 & Metabolism, and Respiratory &
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 astrazeneca.com and
follow the Company on social media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. AstraZeneca PLC. Investor Relations
Epidemiology Spreadsheet. Available
at: https://www.astrazeneca.com/investor-relations.html. Accessed
June 2025.
2. Witjes JA, et al. EAU Guidelines on
muscle-invasive and metastatic bladder
cancer. Eur Urol. 2021;1-94.
3. ESMO. Durvalumab NIAGARA.
Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards?scorecard=498-1%22+%5Ch. Accessed
June 2025.
4. ESMO. About the ESMO-MCBS.
Available at: https://www.esmo.org/guidelines/esmo-mcbs/about-the-esmo-mcbs.
Accessed June 2025.
5. World Health Organization.
International Agency for Research on Cancer. Bladder Fact Sheet.
Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf.
Accessed June 2025.
6. American Cancer Society. What
Is Bladder Cancer? Available at: https://www.cancer.org/cancer/bladder-cancer/about/what-is-bladder-cancer.html. Accessed
June 2025.
Matthew Bowden
Company Secretary
AstraZeneca PLC
SIGNATURES
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.
Date: 04 July 2025
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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