25 June 2024
Imfinzi
demonstrated
statistically significant and clinically meaningful improvement in
event-free survival and overall survival for
muscle-invasive bladder
cancer in NIAGARA Phase III trial
First immunotherapy regimen before
and after
surgery to
extend survival in bladder
cancer
Positive high-level results from the
NIAGARA Phase III trial showed AstraZeneca's Imfinzi (durvalumab) in
combination with chemotherapy demonstrated a statistically
significant and clinically meaningful improvement in the
primary endpoint of event-free survival (EFS) and the key
secondary endpoint of overall survival (OS) versus neoadjuvant
chemotherapy for patients with muscle-invasive bladder cancer
(MIBC). Patients were treated with Imfinzi in combination with
neoadjuvant chemotherapy before cystectomy (surgery to remove the
bladder) followed by Imfinzi as adjuvant
monotherapy.
Approximately one in four patients
with bladder cancer has evidence of the tumour invading
the muscle wall of the bladder (without distant
metastases), known as MIBC.1,2 In the MIBC setting,
approximately 117,000 patients are treated with current standard of
care.3 Standard treatment
includes neoadjuvant chemotherapy and radical
cystectomy.4 However, even after cystectomy, patients
experience high rates of recurrence and a poor
prognosis.4
Professor Thomas Powles, MD,
Professor, Director of Barts Cancer Centre (QMUL), London, UK, and
investigator in the trial, said: "Nearly half of patients with
muscle-invasive bladder cancer who receive standard of care still
experience disease recurrence or progression. These NIAGARA
data show for the first time that adding durvalumab to
chemotherapy before surgery followed by durvalumab extends
patients' lives."
Susan Galbraith, Executive Vice
President, Oncology R&D, AstraZeneca, said: "The NIAGARA
results support our strategy to move immunotherapy to the
early stages of cancer treatment. This perioperative regimen with
Imfinzi improved survival
and reduced the rate at which patients experience disease
recurrence or progression. We are eager to bring this regimen with
the potential to transform the standard of care to patients as soon
as possible."
Imfinzi was generally
well-tolerated and no new safety concerns were observed in either
the neoadjuvant or adjuvant setting. The safety profile of
Imfinzi and neoadjuvant
chemotherapy was consistent with the known profile of the
individual medicines. The addition of Imfinzi did not increase the
discontinuation rate due to adverse events and did not compromise patients' ability to complete
surgery compared to neoadjuvant
chemotherapy alone. These data will be presented at a forthcoming
medical meeting and shared with global regulatory
authorities.
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.5 The most common type of bladder cancer is
urothelial carcinoma, which begins in the urothelial cells of the
urinary tract.6
Muscle-invasive bladder cancer,
named for its growth into the muscle wall of the bladder, accounts
for about a quarter of all bladder cancer cases.1,2
Approximately 50% of patients who undergo bladder removal surgery
experience disease recurrence.4 Treatment options that
prevent disease recurrence after surgery are critically
needed.
NIAGARA
NIAGARA is a randomised, open-label,
multi-centre, global Phase III trial evaluating Imfinzi as treatment for patients with
MIBC before and after radical cystectomy. In the trial, 1063
patients were randomised to receive Imfinzi plus chemotherapy or
chemotherapy alone prior to cystectomy, followed by Imfinzi or no further treatment after
surgery.
The trial is being conducted at 192
centres across 22 countries and regions including in North America,
South America, Europe, Australia and Asia. Its dual primary
endpoints are EFS, defined as the time from treatment randomisation
to an event like tumour recurrence or progression and pathologic
complete response. 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.
Imfinzi is
the only approved immunotherapy and the global standard of care in
the curative-intent setting of unresectable, Stage III non-small
cell lung cancer (NSCLC) in patients whose disease has not
progressed after chemoradiation therapy. Imfinzi is also approved for the
treatment of extensive-stage small cell lung cancer (SCLC) and in
combination with a short course of Imjudo (tremelimumab) and chemotherapy for
the treatment of metastatic NSCLC.
Imfinzi in
combination with neoadjuvant platinum-containing chemotherapy
before surgery and as adjuvant monotherapy after surgery has been
approved in Switzerland for the treatment of adult patients
with resectable NSCLC and no known epidermal
growth factor receptor (EGFR) mutations or anaplastic lymphoma
kinase (ALK) rearrangements.
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 and in combination with chemotherapy (carboplatin plus
paclitaxel) followed by Imfinzi monotherapy in primary
advanced or recurrent endometrial cancer that is mismatch repair
deficient in the US.
Since the first approval in May
2017, more than 220,000 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, breast cancer, several gastrointestinal
and gynaecologic cancers, and other solid
tumours.
Imfinzi is being tested across
early- and late-stage bladder cancer in various treatment
combinations, including in non-muscle invasive disease (POTOMAC),
patients with MIBC who are cisplatin-ineligible or refusing
cisplatin (VOLGA) and locally advanced or metastatic disease
(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 as well
as 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
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@AstraZeneca.
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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 June
2024.
3. Cerner CancerMPact
database. Accessed June 2024. Reflects epidemiology estimates
across G8 countries (US, EU, Japan, China).
4. Witjes JA, et al. EAU Guidelines on muscle-invasive and
metastatic bladder cancer. Eur
Urol. 2021;1-94.
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 June 2024.
6. American Cancer Society. What Is Bladder Cancer? Available at:
https://www.cancer.org/cancer/bladder-cancer/about/what-is-bladder-cancer.html.
Accessed June 2024.
Adrian Kemp
Company Secretary
AstraZeneca PLC