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
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi approved in US for early bladder cancer
29 May 2026
Imfinzi approved
in the US in first and only immunotherapy combination for patients
with BCG-naïve, high-risk non-muscle-invasive
bladder cancer
Based on POTOMAC Phase III trial results which showed a 32%
reduction in the risk of high-risk disease recurrence, progression
or death after one year of Imfinzi added to BCG vs. BCG
alone
AstraZeneca's Imfinzi (durvalumab) in combination with Bacillus
Calmette-Guérin (BCG) induction and
maintenance therapy has been approved in the US for the treatment
of adult patients with BCG-naïve, high-risk
non-muscle-invasive bladder cancer (NMIBC).
The approval by the Food and Drug Administration (FDA) is based
on positive
results from
the POTOMAC Phase III trial which were presented at the European
Society for Medical Oncology (ESMO) Congress 2025 and
simultaneously published in The
Lancet.
In 2024,
over 31,000 people in the US were treated for high-risk
NMIBC, a
curative-intent setting where the standard of care is tumour
resection followed by BCG treatment directly into the
bladder.1,2 About
half of patients with NMIBC are at high-risk for disease recurrence
or progression based on certain characteristics of their cancer,
such as tumour grade, stage and specific tumour
features.3 Up
to 80% of high-risk patients experience disease recurrence within
five years of treatment.3,4
Neal Shore, MD, FACS, Director of START Carolinas / Head of the
Carolina Urologic Research Center and co-principal investigator in
the trial, said: "The durvalumab plus BCG regimen is the first new
therapy approved in over 30 years for patients with BCG-naïve,
high-risk non-muscle-invasive bladder cancer. Unfortunately, many
of these patients experience disease recurrence requiring repeated
surgical procedures, as well as disease progression resulting in
surgical removal of their bladder. The POTOMAC trial demonstrates
that the durvalumab with BCG induction and maintenance regimen
reduces the risk of disease recurrence, progression or death for
patients by almost a third compared to BCG alone, heralding a
marked advancement for patients with high-risk non-muscle-invasive
bladder cancer."
Dave Fredrickson, Executive Vice President, Oncology Haematology
Business Unit, AstraZeneca, said: "Today's approval
for Imfinzi brings the first immunotherapy combination
regimen to patients in the US with BCG-naïve, high-risk
non-muscle-invasive bladder cancer, an early setting that builds on
the positive impact Imfinzi is already having in muscle-invasive
disease. The early and sustained disease-free survival benefit
demonstrated by Imfinzi plus BCG in the POTOMAC trial is an
important advance for patients at risk of early disease recurrence
and signals a shift in the standard of care."
Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network,
said: "It is devastating for patients with high-risk
non-muscle-invasive bladder cancer to face the common, early and
repeated disease recurrences that are the hallmark of this disease,
let alone the prospect of progressing to more advanced disease and
life-changing surgeries. New and effective treatment options that
address their significant burden are always good news and are
urgently needed, so today's approval could offer meaningful hope
for patients and their families."
Results from the POTOMAC trial showed adding one year of treatment
with Imfinzi to BCG induction and maintenance therapy
demonstrated a 32% reduction in the risk of high-risk disease
recurrence, progression or death in patients with BCG-naïve,
high-risk NMIBC compared to BCG alone (based on a disease-free
survival (DFS) hazard ratio of 0.68; 95% confidence interval
0.50-0.93; p=0.0154). With a median follow-up of more than five
years (60.7 months), the Imfinzi regimen delivered an early and sustained DFS
benefit starting less than four months after beginning treatment.
Estimated median DFS was not yet reached for either
arm.
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 signals identified with a median
follow-up of more than five years for DFS. The addition
of Imfinzi did not compromise patients' ability to
complete BCG induction and maintenance therapy and had no
meaningful impact on patient-reported quality of
life.
Regulatory submissions based on the POTOMAC results are under
review in the European Union (EU), Japan and several other
countries.
Last week, positive
high-level results from
the VOLGA Phase III trial were announced, showing that
perioperative treatment with Imfinzi 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) who were ineligible for or had declined cisplatin-based
chemotherapy. 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.
Imfinzi is
also approved in several countries for patients with
cisplatin-eligible MIBC, based on the NIAGARA Phase III
trial, and continues to be 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.5 The
most common type is urothelial carcinoma, which begins in the
urothelial cells of the urinary tract.6 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.6,7
Many high-risk
NMIBC patients with
recurrent disease undergo additional rounds of chemotherapy and
repeated invasive procedures such as transurethral
resection of bladder tumour (TURBT), and
they may ultimately need surgery to remove the bladder
(cystectomy). High-risk patients who experience early recurrence
and those who become unresponsive to BCG treatment are at a
particularly increased risk of disease progression that may require
bladder removal, underscoring the critical need for new
treatment options in this curative-intent
setting.2
POTOMAC
POTOMAC is a randomised, open-label, multi-centre, global Phase III
trial evaluating Imfinzi in combination with BCG therapy as a
treatment for patients with BCG-naïve, high-risk NMIBC who
have undergone TURBT prior to randomisation. In the trial, 1,018
patients were randomised 1:1:1 to receive Imfinzi plus BCG induction and maintenance therapy,
or Imfinzi plus BCG induction-only therapy, versus BCG
induction and maintenance therapy. In the POTOMAC trial, patients
received six weeks of BCG induction therapy with or without two
years of BCG maintenance therapy. With median follow-up for DFS
exceeding five years, the POTOMAC trial features a notably long
observation period among NMIBC trials.
The trial was conducted in more than 120 centres across 12
countries including Canada, Australia, 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,
progression 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 indications 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). It is also
approved as a monotherapy in unresectable HCC in Japan, China 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.
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. AstraZeneca PLC. Investor relations
epidemiology spreadsheet. Available at: https://www.astrazeneca.com/investor-relations.html.
Accessed May 2026.
2.
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.
3. Porten SP, et al. High-risk
non-muscle-invasive bladder cancer: definition and
epidemiology. Curr Opin
Urol.
2012;22:385-389.
4. Porreca A, et al. Time to
progression is the main predictor of survival in patients with
high-risk non-muscle-invasive bladder cancer: Results from a
machine learning-based analysis of a large multi-institutional
database. Urol Oncol.
2024;42(3):69.e17-69.e25.
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 May 2026.
6.
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.
7. Fuge O, et al. Immunotherapy for
bladder cancer. Res Rep
Urol.
2015;7:65-79.
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: 29 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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