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 May 2025
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi recommended in EU for bladder cancer
27 May 2025
Imfinzi recommended for approval in the EU by
CHMP
as first and only perioperative immunotherapy
for
muscle-invasive bladder cancer
Recommendation 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 recommended for approval 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 Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion on results
from the NIAGARA Phase
III trial, which were presented during a Presidential Symposium at
the 2024 European Society for Medical Oncology (ESMO) Congress and
simultaneously published in The
New England Journal of Medicine.
In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a 32%
reduction in the risk of disease progression, recurrence, not
undergoing surgery, or death versus the comparator arm (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 neoadjuvant chemotherapy with radical
cystectomy alone (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.
Dr Michiel Van der Heijden, medical oncologist and Group Leader at
the Netherlands Cancer Institute, and investigator in the NIAGARA
trial, said: "Approximately half of patients with muscle-invasive
bladder cancer will experience disease recurrence despite
curative-intent treatment with neoadjuvant chemotherapy and surgery
to remove the bladder. This recommendation for the durvalumab-based
perioperative regimen brings us closer to providing an important
new treatment option that has demonstrated a significant survival
benefit, with the potential to transform the treatment approach for
patients across Europe."
Susan Galbraith, Executive Vice President,
Oncology Haematology R&D,
AstraZeneca, said: "The Imfinzi-based
perioperative regimen in the NIAGARA Phase III trial enabled
survival of more than 80 per cent of patients at two years after
treatment. This supports our strategy of moving our innovative
medicines into the earlier stages of disease where the opportunity
for treatment with curative intent is greatest. If approved, this
novel approach will become a much-needed new treatment option for
patients in Europe and could become the new standard of care in
this setting."
In 2024, over 35,000 people in the five major European countries
were treated for MIBC.1 Bladder
cancer is considered muscle-invasive when there is evidence of the
tumour invading the muscle wall of the bladder but no distant
metastases.2 Despite
this representing a curative-intent setting, where the current
standard-of-care is neoadjuvant chemotherapy and radical
cystectomy, many patients experience disease recurrence after
surgery and have a poor prognosis.3
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.
Imfinzi is approved
in the US and
other countries in this setting based on the NIAGARA results.
Regulatory applications are currently under review in Japan and
several other countries.
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.4 The
most common type of bladder cancer is urothelial carcinoma, which
begins in the urothelial cells of the urinary
tract.2 In
MIBC, approximately 50% of patients who undergo bladder removal
surgery experience disease recurrence.3 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 across 22 countries
including in 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 demonstrated
a statistically significant and clinically meaningful improvement
in 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 non-small
cell lung cancer (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 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.
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 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 EU
and Japan.
Since the first approval in May 2017, more than 374,000 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 May 2025
2. American Cancer
Society. What Is Bladder Cancer? Available at: https://www.cancer.org/cancer/bladder-cancer/about/what-is-bladder-cancer.html.
Accessed May 2025.
3. Witjes JA, et al. EAU Guidelines on
muscle-invasive and metastatic bladder
cancer. Eur Urol. 2021;1-94.
4. 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 May 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.
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AstraZeneca
PLC
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Date:
27 May 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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