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 2026
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 + EV
improves EFS & OS in bladder cancer
14 May 2026
Perioperative Imfinzi plus neoadjuvant EV showed statistically
significant and clinically meaningful improvements in event-free
survival and overall survival in muscle-invasive bladder cancer in
the Phase III VOLGA trial
Perioperative Imfinzi plus Imjudo and neoadjuvant EV showed a
statistically significant and clinically meaningful improvement in
event-free survival and a favourable trend for overall
survival
High-level results from a planned interim analysis of the VOLGA
Phase III trial showed perioperative treatment
with Imfinzi (durvalumab) in combination with neoadjuvant
enfortumab vedotin (EV) demonstrated statistically significant and
clinically meaningful improvements in event-free survival (EFS) and
overall survival (OS) in patients with muscle-invasive bladder
cancer (MIBC) versus standard of care. Patients were ineligible for
or had declined cisplatin-based chemotherapy. Patients in the
comparator arm had a radical cystectomy (surgery to remove the
bladder) with or without approved adjuvant
treatment.
Perioperative Imfinzi plus Imjudo (tremelimumab) in combination with
neoadjuvant EV demonstrated a statistically significant and
clinically meaningful improvement in EFS and a favourable trend for
OS; however, the OS data were not statistically significant at this
planned interim analysis and will be formally reassessed at a
subsequent analysis.
Approximately one in four patients with bladder cancer has
muscle-invasive disease, where the tumour invades the muscle wall
of the bladder, without distant metastases.1,2 As
many as 50% of patients are ineligible for cisplatin-based
chemotherapy due to impaired renal function or
comorbidities.3,4 The
standard treatment for these patients has historically been radical
cystectomy alone but, despite undergoing this major surgery,
patients experience high rates of recurrence and have a poor
prognosis.3-5
Thomas Powles, MD, Professor, Chair of Barts Cancer Centre (QMUL),
London, UK, and International Coordinating Investigator for the
trial, said: "Up to half of patients with muscle-invasive bladder
cancer are not eligible for cisplatin and face high rates of
disease recurrence, even after having their bladder removed,
leaving a significant need for new effective and well-tolerated
treatments. The VOLGA results show that perioperative durvalumab
significantly extends event-free survival and overall survival when
combined with neoadjuvant enfortumab vedotin, with a manageable
safety profile, compared to surgery for patients in this
curative-intent setting."
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: "This interim analysis from the VOLGA
trial highlights the benefit of
perioperative Imfinzi with neoadjuvant enfortumab vedotin compared
to surgery, a novel regimen that optimises treatment options for
patients. Together with
NIAGARA and POTOMAC, VOLGA is our third positive readout in bladder
cancer, setting a strong foundation for Imfinzi as the immunotherapy backbone in this
early-stage, curative-intent setting."
The safety and tolerability of Imfinzi with
or without Imjudo plus EV was consistent with the known safety
profiles of the individual medicines, with no new safety signals
identified. These data will be presented at a forthcoming medical
meeting and shared with global regulatory
authorities.
Imfinzi is
approved in over 40 countries for patients
with cisplatin-eligible MIBC,
based on the NIAGARA Phase III trial. Additionally, Imfinzi added
to Bacillus Calmette-Guérin 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
and is currently under review in the US, European Union (EU), Japan
and several other countries. Imfinzi is
also being investigated in locally advanced or metastatic
disease in the NILE Phase III
trial.
Notes
Bladder cancer
Bladder cancer is the 9th most common cancer in the world, with
more than 614,000 cases diagnosed each year.6 The
most common type is urothelial carcinoma, which begins in the
urothelial cells of the urinary tract.7
In 2024, an estimated 117,500 patients were treated for MIBC with
the standard of care, which included neoadjuvant cisplatin-based
chemotherapy and radical cystectomy.5,8 In
2025, the NIAGARA Phase III trial established a new standard by
adding perioperative Imfinzi to the regimen.9 However,
up to half of patients are not eligible to receive cisplatin, and
approximately 50% of MIBC patients who undergo bladder removal
surgery experience disease recurrence.3,5 New
treatment options that prevent both progression before surgery and
recurrence after surgery are critically needed in this
curative-intent setting.
VOLGA
VOLGA is a Phase III, randomised, open-label, multi-centre global
trial evaluating perioperative Imfinzi with or without Imjudo in combination with neoadjuvant EV as
treatment for patients with MIBC undergoing radical cystectomy who
are not eligible for or have declined cisplatin compared to radical
cystectomy with or without approved adjuvant therapy. In the trial,
695 patients were randomised 1:1:1 to Arm 1 (three cycles
of Imfinzi and EV, plus two cycles
of Imjudo prior to surgery, followed by nine cycles
of Imfinzi plus one cycle of Imjudo as adjuvant therapy), Arm 2 (three cycles
of Imfinzi and EV prior to surgery, followed by nine
cycles of Imfinzi adjuvant monotherapy) and Arm 3, the
comparator arm.
The trial was conducted in 182 centres across 25 countries in
Europe, North America, South America and Asia. Its dual primary
endpoints are EFS, defined as the time from randomisation to first
recurrence post-radical cystectomy, first progression in patients
who did not undergo radical cystectomy, failure to undergo radical
cystectomy in patients with residual disease or death due to any
cause, for both experimental arms versus the comparator arm.
Secondary endpoints include OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm
3), pathologic complete response, disease-free survival and
pathologic downstaging across both experimental arms.
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 (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 resectable gastric and
gastroesophageal junction cancers,
perioperative Imfinzi added to standard-of-care chemotherapy is
approved in the US and EU. Additionally, in April
2026, Imfinzi in combination with Imjudo, lenvatinib and transarterial chemoembolisation
(TACE) demonstrated a statistically significant and clinically
meaningful improvement in the primary endpoint of progression-free
survival versus TACE alone for patients with unresectable HCC
eligible for embolisation in the EMERALD-3 Phase III
trial.
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 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 SCLC, NSCLC, bladder
cancer, breast cancer, several gastrointestinal and gynaecologic
cancers, and other solid tumours.
Imjudo
Imjudo (tremelimumab) is a
human monoclonal antibody that targets the activity of cytotoxic
T-lymphocyte-associated protein 4
(CTLA-4). Imjudo blocks
the activity of CTLA-4, contributing to T-cell activation, priming
the immune response to cancer and fostering cancer cell death. In
addition to its approved indications in liver and lung
cancers, Imjudo is
being tested in combination with Imfinzi across
other tumour types including SCLC (ADRIATIC) and bladder cancer
(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 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/NYSE: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Disease, 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 May
2026.
3.
Dash A, et al. Impact of renal impairment on
eligibility for adjuvant cisplatin-based chemotherapy in
patients with urothelial carcinoma of the
bladder. Cancer. 2006;107(3):506-513.
4.
Galsky MD, et al. Treatment of patients with
metastatic urothelial cancer "unfit" for cisplatin-based
chemotherapy. J Clin
Oncol. 2011;29(17):2432-2438.
5.
Van der
Heijden AG, et al. EAU
Guidelines on Muscle-invasive and Metastatic Bladder Cancer. 2026.
Edn. Presented at the EAU Annual Congress Copenhagen 2026. ISBN
978-94-92671-30-1.
6.
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 2026.
7.
American
Cancer Society. What Is Bladder Cancer? Available at:
https://www.cancer.org/cancer/bladder-cancer/about/what-is-bladder-cancer.html.
Accessed May 2026.
8.
AstraZeneca
PLC. Investor relations epidemiology spreadsheet. Available
at: https://www.astrazeneca.com/investor-relations.html.
Accessed May 2026.
9.
AstraZeneca
PLC. Imfinzi approved in the US as first and only perioperative
immunotherapy for patients with muscle-invasive bladder cancer.
Available at:
https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html.
Accessed May 2026.
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:
14 May 2026
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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