REG - AstraZeneca PLC - Imfinzi approved in US for early bladder cancer

AstraZenecaAnnouncement

29/05/2026 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260529:nRSc1374Ga&default-theme=true

RNS Number : 1374G  AstraZeneca PLC  29 May 2026

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
(https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-regimen-reduced-risk-of-disease-recurrence-death-32-percent-high-risk-non-muscle-invasive-bladder-cancer-in-the-potomac-phase-iii-trial.html)
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
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01897-5/fulltext)
.

 

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
(https://www.astrazeneca.com/media-centre/press-releases/2026/imfinzi-ev-improves-efs-os-in-bladder-cancer.html)
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 (https://www.astrazeneca.com/)

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 (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/contacts-information.html) .
For Media contacts, click here
(https://www.astrazeneca.com/media-centre/contacts.html) .

 

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

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCAKFBBKBKBCPB



            Copyright 2019 Regulatory News Service, all rights reserved