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 March 2025
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi approved in the US for bladder cancer
31 March 2025
Imfinzi approved
in the US as first and only perioperative
immunotherapy for patients with muscle-invasive
bladder cancer
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 vs. neoadjuvant chemotherapy alone
AstraZeneca's Imfinzi (durvalumab) in
combination with gemcitabine and cisplatin as neoadjuvant
treatment, followed by Imfinzi as
adjuvant monotherapy after radical cystectomy (surgery to
remove the bladder) has
been approved in the US for the treatment of adult
patients with
muscle-invasive bladder cancer (MIBC).
The approval was granted by the Food and Drug Administration (FDA)
after securing Priority
Review and
was based 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 2024, over 20,000 people in the US 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 This
represents a curative-intent setting, where the current standard of
care is neoadjuvant chemotherapy and radical
cystectomy.3 However,
even after surgery, patients experience high rates of disease
recurrence and have a poor prognosis.3
Matthew ND. Galsky, Lillian and Howard Stratton Professor of
Medicine, Director of Genitourinary Medical Oncology, The Tisch
Cancer Institute at the Icahn School of Medicine at Mount Sinai,
New York, and NIAGARA investigator and steering committee member,
said: "This approval for the durvalumab-based perioperative regimen
is a major breakthrough for people with muscle-invasive bladder
cancer, nearly
half of whom see their cancer return despite chemotherapy and
surgery with curative-intent. This durvalumab regimen significantly
extended patients' lives in the NIAGARA trial and has the potential
to transform care."
Dave Fredrickson, Executive Vice President,
Oncology Haematology Business
Unit, AstraZeneca, said: "Today's approval
for Imfinzi represents
a paradigm shift, bringing the first perioperative immunotherapy to
patients in the US with muscle-invasive bladder cancer and
addressing a significant need for better treatment
options. The
NIAGARA trial showed
more than 80 per cent of patients were still alive at two
years, underscoring
the potential of this innovative perioperative regimen to become a
new standard of care in this setting."
Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network,
said: "More than 20,000 people in the US were treated for
muscle-invasive bladder cancer last year and there is a significant
need for new treatment options that improve patient outcomes. The
approval of the durvalumab perioperative regimen is welcome news,
transforming how clinicians will tackle this disease in future and
offering new hope to patients and their loved ones."
In the trial, patients were treated with four cycles
of Imfinzi in
combination with neoadjuvant chemotherapy before radical cystectomy
followed by eight cycles of Imfinzi monotherapy,
or neoadjuvant chemotherapy before radical cystectomy. 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 (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.
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 (imAEs) were
consistent with the known profile of Imfinzi, manageable and mostly
low-grade.
In February 2025, perioperative treatment with durvalumab
(Imfinzi), neoadjuvant cisplatin-based chemotherapy and
cystectomy was added to the NCCN Clinical Practical Guidelines in
Oncology (NCCN Guidelines®)
as a NCCN Category 1 Recommended regimen for patients with MIBC
based on the data from NIAGARA.4
Imfinzi is
also approved in Brazil in this setting based on the NIAGARA
results. Regulatory applications are currently under review in the
EU, 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.5 The
most common type of bladder cancer is urothelial carcinoma, which
begins in the urothelial cells of the urinary
tract.6 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 Imfinzi plus neoadjuvant chemotherapy prior to
cystectomy followed by Imfinzi, 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 (pCR) 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 addition to the indication in bladder
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 (etoposide
and either carboplatin or cisplatin) for the treatment of
extensive-stage SCLC.
In addition to its indications in lung
cancers, Imfinzi is approved in combination with chemotherapy
(gemcitabine plus cisplatin) 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 event-free survival 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
SCLC, NSCLC, bladder cancer, breast cancer, several
gastrointestinal and gynaecologic cancers, and other solid
tumours.
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 March 2025.
2. National
Collaborating Centre for Cancer. Bladder Cancer: Diagnosis and
Management. London: National Institute for Health and Care
Excellence (NICE). Available at: https://www.ncbi.nlm.nih.gov/books/NBK356289.
Accessed March 2025.
3. Witjes JA, et al. EAU Guidelines on
muscle-invasive and metastatic bladder
cancer. Eur Urol. 2021;1-94.
4.
NCCN, National Comprehensive Cancer Network® (NCCN®).
Referenced with permission from the NCCN Clinical Practice
Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer
Version 7.2024.© National Comprehensive Cancer Network, Inc.
[2025]. All rights reserved. Accessed [February 28, 2025]. To view
the most recent and complete version of the guideline, go online to
NCCN.org. NCCN makes no warranties of any kind whatsoever regarding
their content, use or application and disclaims any responsibility
for their application or use in any way.
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 March 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 March 2025.
Adrian Kemp
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:
31 March 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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