REG - AstraZeneca PLC - Imfinzi improved DFS in early bladder cancer

AstraZenecaAnnouncement

09/05/2025 07:00

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RNS Number : 9740H  AstraZeneca PLC  09 May 2025

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 (http://www.astrazeneca.com/) and follow the
Company on social media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

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
(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
(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
(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

 

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