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
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 improved DFS in early bladder cancer
09 May 2025
Imfinzi regimen
demonstrated statistically significant and clinically meaningful
improvement in disease-free survival for high-risk
non-muscle-invasive bladder cancer in POTOMAC Phase III
trial
Patients lived significantly longer without high-risk disease
recurrence or progression after one year of Imfinzi treatment plus
Bacillus Calmette-Guérin (BCG) induction and maintenance
therapy vs. BCG alone
Positive high-level results from the POTOMAC Phase III trial showed
one year of treatment with AstraZeneca's Imfinzi (durvalumab) plus standard-of-care BCG
induction and maintenance therapy demonstrated a statistically
significant and clinically meaningful improvement in disease-free
survival (DFS) for patients with high-risk non-muscle-invasive
bladder cancer (NMIBC) compared to BCG induction and maintenance
therapy alone.
The trial was not statistically powered to formally test overall
survival (OS) however a descriptive analysis demonstrated no
detriment.
More than 70% of bladder cancer patients are diagnosed with NMIBC,
an early-stage cancer where the tumour is in the tissue that lines
the inner surface of the bladder but has not invaded the muscle
wall.1-2 About
half of patients with NMIBC are classified as high-risk for disease
progression or recurrence because of certain characteristics of
their cancer, such as tumour grade, stage and specific tumour
features.3
Maria De Santis, MD, Head of the Interdisciplinary Uro-Oncology
Section at Charité Universitätsmedizin Berlin, Germany,
and a principal investigator in the POTOMAC trial, said: "These
exciting data show that adding one year of durvalumab to the
current standard treatment significantly extends the time patients
live without high-risk disease recurrence or progression. While
most patients with non-muscle invasive bladder cancer are treated
with curative intent, 80 per cent see their disease return and
almost half may require life-altering surgery to remove the
bladder, underscoring the urgent need to improve
treatment."
Cristian Massacesi, Chief Medical Officer and Oncology Chief
Development Officer, AstraZeneca, said: "The positive results
for Imfinzi in the POTOMAC trial represent a
significant advance that will potentially allow more patients with
early-stage bladder cancer to benefit from this important
immunotherapy. Building on the NIAGARA data, this outcome
demonstrates our strategy of bringing novel therapies to patients
with early-stage disease where there is the greatest potential for
long-term benefit."
The safety and tolerability of Imfinzi plus BCG induction and maintenance therapy
was consistent with the known safety profiles of the individual
medicines, with no new safety concerns identified. The addition
of Imfinzi did not compromise patients' ability to
complete BCG induction and maintenance
therapy.
The second experimental arm evaluating Imfinzi plus BCG induction-only therapy compared to
BCG induction and maintenance therapy alone did not meet the
endpoint of DFS.
These data will be presented at a forthcoming medical meeting and
shared with global regulatory authorities.
Imfinzi is approved in the
US and other countries for patients with muscle-invasive bladder
cancer (MIBC) based on results from the NIAGARA Phase III trial and
continues to be investigated across early and late-stage bladder
cancer in various treatment combinations, including in patients
with MIBC who are ineligible or refuse to take cisplatin (VOLGA)
and in locally advanced or metastatic disease
(NILE).
Notes
Bladder cancer
Bladder cancer is the 9th most common cancer in the world, with
more than 614,000 cases diagnosed each year.4 The
most common type is urothelial carcinoma, which begins in the
urothelial cells of the urinary tract.2
In 2024, an estimated 125,000 patients were treated for high-risk
NMIBC, for which the current standard of care is transurethral
resection of bladder tumour (TURBT) followed by administration of
BCG directly into the bladder.5-6 Up
to 80% of patients experience disease recurrence within five years,
and rates of progression in high-risk patients can be as high as
45%.2 There
is a critical need for treatment options in this curative-intent
setting.
POTOMAC
POTOMAC is a randomised, open-label, multi-centre, global Phase III
trial evaluating Imfinzi in combination with BCG therapy as a
treatment for 1,018 patients with high-risk, BCG-naïve NMIBC
who have undergone TURBT prior to randomisation. Patients were
randomised 1:1:1 to receive Imfinzi plus BCG induction and maintenance therapy,
or Imfinzi plus BCG induction-only therapy, versus
standard-of-care BCG induction and maintenance
therapy.
The trial was conducted in more than 120 centres across 12
countries including Canada and others across Europe and Asia. The
primary endpoint was DFS, defined as time from randomisation to
date of first recurrence of high-risk disease or death from any
cause, for Imfinzi plus BCG induction and maintenance therapy
compared to BCG induction and maintenance therapy alone. Secondary
endpoints included DFS for Imfinzi plus BCG induction only therapy versus the
comparator arm, as well as OS at five years and safety across both
experimental arms of the trial.
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 its indication in MIBC, 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 European Union
(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
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. Fuge O, et al. Immunotherapy
for bladder cancer. Res Rep
Urol.
2015;7:65-79.
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. Porten SP, Cooperberg MR.
High-risk nonmuscle invasive bladder cancer: definition and
epidemiology. Curr Opin
Urol.
2012;22:385-389.
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.
5. AstraZeneca PLC. Investor
Relations Epidemiology Spreadsheet. Available
at: https://www.astrazeneca.com/investor-relations.html.
Accessed May 2025.
6. Gontero
P, et al. EAU Guidelines on Non-muscle-invasive Bladder Cancer
(TaT1 and CIS). 2025. Edn. presented at the EAU Annual Congress
Madrid 2025. ISBN 978-94-92671-29-5.
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:
09 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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