REG - AstraZeneca PLC - Imfinzi recommended in EU for bladder cancer

AstraZenecaAnnouncement

27/05/2025 07:00

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RNS Number : 0455K  AstraZeneca PLC  27 May 2025

27 May 2025

Imfinzi recommended for approval in the EU by CHMP

as first and only perioperative immunotherapy for

muscle-invasive bladder cancer

 

 Recommendation based on NIAGARA Phase III trial results which showed a 32%
reduction in the risk of recurrence and a 25% reduction in the risk of death
for the Imfinzi regimen vs. neoadjuvant chemotherapy alone

 

AstraZeneca's Imfinzi (durvalumab) has been recommended for approval in the
European Union (EU) for the treatment of adult patients with resectable
muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and
cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy
adjuvant treatment after radical cystectomy (surgery to remove the bladder).

 

The Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency based its positive opinion on results from the NIAGARA
(https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-perioperative-regimen-reduced-risk-recurrence-by-32-risk-death-by-25-vs-neoadjuvant-chemotherapy-alone-in-mibc-niagara-phase-iii-trial.html)
Phase III trial, which were presented during a Presidential Symposium at the
2024 European Society for Medical Oncology (ESMO) Congress and simultaneously
published in The New England Journal of Medicine (https://www.nejm.org/) .

 

In a planned interim analysis, the Imfinzi-based perioperative regimen
demonstrated a 32% reduction in the risk of disease progression, recurrence,
not undergoing surgery, or death versus the comparator arm (based on
event-free survival  EFS  hazard ratio  HR  of 0.68; 95% confidence interval
 CI  0.56-0.82; p<0.0001). Estimated median EFS was not yet reached for
the Imfinzi arm versus 46.1 months for the comparator arm. An estimated
67.8% of patients treated with the regimen were event free at two years
compared to 59.8% in the comparator arm.

 

Results from the key secondary endpoint of overall survival (OS) showed that
the Imfinzi-based perioperative regimen reduced the risk of death by 25%
versus neoadjuvant chemotherapy with radical cystectomy alone (based on OS HR
of 0.75; 95% CI 0.59-0.93; p=0.0106). Median survival was not yet reached for
either arm. An estimated 82.2% of patients treated with the regimen were alive
at two years compared to 75.2% in the comparator arm.

 

Dr Michiel Van der Heijden, medical oncologist and Group Leader at the
Netherlands Cancer Institute, and investigator in the NIAGARA trial, said:
"Approximately half of patients with muscle-invasive bladder cancer will
experience disease recurrence despite curative-intent treatment with
neoadjuvant chemotherapy and surgery to remove the bladder. This
recommendation for the durvalumab-based perioperative regimen brings us closer
to providing an important new treatment option that has demonstrated a
significant survival benefit, with the potential to transform the treatment
approach for patients across Europe."

 

Susan Galbraith, Executive Vice President, Oncology Haematology R&D,
AstraZeneca, said: "The Imfinzi-based perioperative regimen in the NIAGARA
Phase III trial enabled survival of more than 80 per cent of patients at two
years after treatment. This supports our strategy of moving our innovative
medicines into the earlier stages of disease where the opportunity for
treatment with curative intent is greatest. If approved, this novel approach
will become a much-needed new treatment option for patients in Europe and
could become the new standard of care in this setting."

 

In 2024, over 35,000 people in the five major European countries were treated
for MIBC.(1) Bladder cancer is considered muscle-invasive when there is
evidence of the tumour invading the muscle wall of the bladder but no distant
metastases.(2) Despite this representing a curative-intent setting, where the
current standard-of-care is neoadjuvant chemotherapy and radical cystectomy,
many patients experience disease recurrence after surgery and have a poor
prognosis.(3)

 

Imfinzi was generally well tolerated, and no new safety signals were observed
in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to
neoadjuvant chemotherapy was consistent with the known profile for this
combination and did not compromise patients' ability to complete surgery
compared to neoadjuvant chemotherapy alone. Immune-mediated adverse events
were consistent with the known profile of Imfinzi, manageable and mostly
low-grade.

 

Imfinzi is approved in the US
(https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html)
and other countries in this setting based on the NIAGARA results. Regulatory
applications are currently under review in Japan and several other countries.

 

Notes

 

Muscle-invasive bladder cancer

Bladder cancer is the 9th most common cancer in the world, with more than
614,000 patients diagnosed each year.(4) The most common type of bladder
cancer is urothelial carcinoma, which begins in the urothelial cells of the
urinary tract.(2) In MIBC, approximately 50% of patients who undergo bladder
removal surgery experience disease recurrence.(3) Treatment options that
prevent disease recurrence after surgery are critically needed in this
curative-intent setting.

 

NIAGARA
NIAGARA is a randomised, open-label, multi-centre, global Phase III trial
evaluating perioperative Imfinzi as treatment for patients with MIBC before
and after radical cystectomy. In the trial, 1,063 patients were randomised to
receive four cycles of Imfinzi plus neoadjuvant chemotherapy prior to
cystectomy followed by eight cycles of Imfinzi monotherapy, or neoadjuvant
chemotherapy alone prior to cystectomy with no further treatment after
surgery. NIAGARA is the largest global Phase III trial in this setting.

 

The trial is being conducted at 192 centres across 22 countries including in
North America, South America, Europe, Australia and Asia. Its dual primary
endpoints are EFS and pathologic complete response at the time of cystectomy.
Key secondary endpoints are OS and safety.

 

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 May 2025, Imfinzi plus standard-of-care Bacillus Calmette-Guérin induction
and maintenance therapy demonstrated a statistically significant and
clinically meaningful improvement in disease-free survival for patients with
high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.

 

In lung 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
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 EU.

 

In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy
met the primary endpoint of EFS 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://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.   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

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.   Witjes JA, et al. EAU Guidelines on muscle-invasive and metastatic
bladder cancer. Eur Urol. 2021;1-94.

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.

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

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