a7454t
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 June 2024
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 improved EFS and OS in bladder cancer
25 June 2024
Imfinzi demonstrated
statistically significant and clinically meaningful improvement in
event-free survival and overall survival for
muscle-invasive bladder cancer in NIAGARA Phase III
trial
First immunotherapy regimen before and after
surgery to extend survival
in bladder cancer
Positive high-level results from the NIAGARA Phase III trial showed
AstraZeneca's Imfinzi (durvalumab)
in combination with chemotherapy demonstrated a statistically
significant and clinically meaningful improvement in the
primary endpoint of event-free survival (EFS) and the key
secondary endpoint of overall survival (OS) versus neoadjuvant
chemotherapy for patients with muscle-invasive bladder cancer
(MIBC). Patients were treated with Imfinzi in combination with neoadjuvant chemotherapy
before cystectomy (surgery to remove the bladder) followed
by Imfinzi as adjuvant monotherapy.
Approximately one in four patients with bladder cancer has evidence
of the tumour invading the
muscle wall of the bladder (without distant metastases), known as
MIBC.1,2 In
the MIBC setting, approximately 117,000 patients are treated with
current standard of care.3 Standard
treatment includes neoadjuvant chemotherapy and radical
cystectomy.4 However,
even after cystectomy, patients experience high rates of recurrence
and a poor prognosis.4
Professor Thomas Powles, MD, Professor, Director of Barts Cancer
Centre (QMUL), London, UK, and investigator in the trial, said:
"Nearly half of patients with muscle-invasive bladder cancer
who receive standard of care still experience disease recurrence or
progression. These NIAGARA data show for the first time that
adding durvalumab to chemotherapy before surgery followed by
durvalumab extends patients' lives."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "The NIAGARA results support our strategy
to move immunotherapy to the early stages of cancer treatment.
This perioperative regimen with Imfinzi improved survival and reduced the rate at
which patients experience disease recurrence or progression. We are
eager to bring this regimen with the potential to transform the
standard of care to patients as soon as
possible."
Imfinzi was generally
well-tolerated and no new safety concerns were observed in either
the neoadjuvant or adjuvant setting. The safety profile
of Imfinzi and
neoadjuvant chemotherapy was consistent with the known profile of
the individual medicines. The addition of Imfinzi did
not increase the discontinuation rate due to adverse events
and did
not compromise patients' ability to complete
surgery compared
to neoadjuvant chemotherapy alone. These data will be presented at
a forthcoming medical meeting and shared with global regulatory
authorities.
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
Muscle-invasive bladder cancer, named for its growth into the
muscle wall of the bladder, accounts for about a quarter of all
bladder cancer cases.1,2 Approximately
50% of patients who undergo bladder removal surgery experience
disease recurrence.4 Treatment
options that prevent disease recurrence after surgery are
critically needed.
NIAGARA
NIAGARA is a randomised, open-label, multi-centre, global Phase III
trial evaluating Imfinzi as treatment for patients with MIBC before
and after radical cystectomy. In the trial, 1063 patients were
randomised to receive Imfinzi plus chemotherapy or chemotherapy alone
prior to cystectomy, followed by Imfinzi or no further treatment after
surgery.
The trial is being conducted at 192 centres across 22 countries and
regions including in North America, South America, Europe,
Australia and Asia. Its dual primary endpoints are EFS, defined as
the time from treatment randomisation to an event like tumour
recurrence or progression and pathologic complete response. 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.
Imfinzi is
the only approved immunotherapy and the global standard of care in
the curative-intent setting of unresectable, Stage III non-small
cell lung cancer (NSCLC) in patients whose disease has not
progressed after chemoradiation therapy. Imfinzi is
also approved for the treatment of extensive-stage small cell lung
cancer (SCLC) and in combination with a short course
of Imjudo (tremelimumab) and
chemotherapy for the treatment of metastatic
NSCLC.
Imfinzi in
combination with neoadjuvant platinum-containing chemotherapy
before surgery and as adjuvant monotherapy after surgery has been
approved in Switzerland for the treatment of adult
patients with
resectable NSCLC and no known epidermal growth factor receptor
(EGFR) mutations or anaplastic lymphoma kinase (ALK)
rearrangements.
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 and in combination with
chemotherapy (carboplatin plus paclitaxel) followed
by Imfinzi monotherapy in primary advanced or recurrent
endometrial cancer that is mismatch repair deficient in the
US.
Since the first approval in May 2017, more than 220,000 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, breast cancer, several gastrointestinal and
gynaecologic cancers, and other solid
tumours.
Imfinzi is
being tested across early- and late-stage bladder cancer in various
treatment combinations, including in non-muscle invasive disease
(POTOMAC), patients with MIBC who are cisplatin-ineligible or
refusing cisplatin (VOLGA) and locally advanced or metastatic
disease (NILE).
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 as well as 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. Burger
M, et al. Epidemiology and Risk Factors of Urothelial Bladder
Cancer. Eur
Urol.
2013;63(2):234-241.
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 June
2024.
3.
Cerner CancerMPact database. Accessed June 2024. Reflects
epidemiology estimates across G8 countries (US, EU, Japan,
China).
4. Witjes
JA, et al. EAU Guidelines on muscle-invasive and metastatic bladder
cancer. Eur
Urol.
2021;1-94.
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 2024.
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 2024.
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.
Date:
25 June 2024
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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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