Imfinzi approved in Canada as first and only perioperative immunotherapy for muscle invasive bladder cancer

MISSISSAUGA, ON, Aug. 6, 2025 /CNW/ - Health Canada has granted a Notice of Compliance (NOC) for Imfinzi^® (durvalumab) for the treatment of patients with resectable muscle invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by adjuvant Imfinzi monotherapy treatment after radical cystectomy. The approval is based on results from the NIAGARA Phase III trial, which were published in The New England Journal of Medicine.^1,2

In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a statistically significant and clinically meaningful 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus neoadjuvant chemotherapy with radical cystectomy alone (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 plus gemcitabine and cisplatin 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.²

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 the comparator arm (based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.011). 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.²

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. The most common adverse events (any Grade, occurring in ≥10% of patients) for the Imfinzi plus chemotherapy arm were nausea (53.6%), fatigue (51.5%), neutropenia (40.4%), anemia (38.7%), constipation (38.7%), decreased appetite (26.6%), rash (20.9%), pyrexia (20.8%), diarrhea (20.6%), abdominal pain (20.2%), vomiting (19.2%), blood creatine increased (18.5%), thrombocytopenia (17.2%), pruritus (15.1%), hypothyroidism (12.6%), neuropathy peripheral (12.5%), leukopenia (10.9%), and aspartate aminotransferase increased (10.4%).¹

"Health Canada's approval of this durvalumab-based perioperative regimen represents a major advance for Canadians with muscle invasive bladder cancer, where nearly half will relapse despite curative treatment," says Dr. Srikala Sridhar, Professor of Medicine at the University of Toronto, Genitourinary Medical Oncologist at the Princess Margaret Cancer Centre and NIAGARA trial investigator. "Findings from the NIAGARA trial showed that this new regimen reduces risk of recurrence and significantly improves survival – which may offer new hope and potential to transform care in this setting."

"The high rate of recurrence associated with muscle invasive bladder cancer is an ongoing challenge and source of concern for physicians and patients," says Dr. Normand Blais, Medical Oncologist at the Centre hospitalier de l'Université de Montréal. "The Health Canada approval based on results from the NIAGARA trial may now offer us the opportunity to increase the chance of better patient outcomes and long-term survival by the use of immunotherapy in this setting, which is very good news for patients and their families."

Bladder cancer is the 5th most common cancer in Canada, with more than 13,000 patients diagnosed each year.³ The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract. Bladder cancer is considered muscle invasive when there is evidence of the tumour invading the muscle wall of the bladder but no distant metastases.⁴ In MIBC, approximately 50% of patients who undergo bladder removal surgery experience disease recurrence.⁵ Treatment options that prevent disease recurrence after surgery are critically needed in this curative-intent setting.

"This decision by Health Canada represents an important step forward for all Canadians affected by muscle invasive bladder cancer," says Michelle Colero, Executive Director, Bladder Cancer Canada. "For many patients and families, the fear of recurrence after surgery has been overwhelming. This new treatment option may offer renewed hope for longer, healthier lives."

About NIAGARA²
NIAGARA is a randomized, 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 randomized 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 to date.

The trial is being conducted at 192 centres in 22 countries across North America (including Canada), 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.

About 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.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical business whose innovative medicines are used by millions of patients worldwide. The company's core areas of scientific focus are Oncology; Cardiovascular, Renal and Metabolic (CVRM); Rare Disease; Respiratory & Immunology; and Vaccine & Immune Therapies. In Canada, the company employs more than 2,400 people and recently announced a major expansion of its research footprint in Mississauga – including the expansion of its AstraZeneca R&D Hub and the creation of a new Alexion Development Hub for Rare Diseases. AstraZeneca was recently recognized as one of Canada's Top 100 Employers, one of Canada's Most Admired Corporate Cultures, and a Greater Toronto Top Employer.

AstraZeneca is committed to contributing to a more sustainable future for people, society and planet taking important steps to help tackle some of the most pressing sustainability challenges globally – from climate and biodiversity loss, to health equity and health system resilience. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard. For more information, please visit the company's website at www.astrazeneca.ca.  

Imfinzi^® and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc.

References: 

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¹ Imfinzi (durvalumab) Product Monograph,. AstraZeneca Canada Inc., July 17, 2025.

² Powles T, et al. Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. New England Journal of Medicine. 2024; 391(19): 1773-1786.

³ Bladder Cancer Canada. Bladder Cancer Statistics and Risk Factors. Available at: https://bladdercancercanada.org/en/bladder-cancer/bladder-cancer-statistics-and-risk-factors/. Accessed on July 16, 2025.

⁴ Bladder Cancer Canada. Types of Bladder Cancer – Muscle Invasive Bladder Cancer. Available at: https://bladdercancercanada.org/en/bladder-cancer/types-of-bladder-cancer/muscle invasive-bladder-cancer/. Accessed on: July 16, 2025.

⁵ Witjes JA, et al. EAU Guidelines on muscle invasive and metastatic bladder cancer. Eur Urol. 2021;1-94.

SOURCE AstraZeneca Canada Inc.

AstraZeneca Canada, Email: [email protected]