Health Canada Approves IMFINZI® (durvalumab) for Previously Treated Patients with Advanced Bladder Cancer

Approval granted based on promising tumour response rate and duration of response

MISSISSAUGA, ON, Nov. 6, 2017 /CNW/ - AstraZeneca Canada today announced that Health Canada has approved Imfinzi® (durvalumab) for the treatment of advanced bladder cancer in previously treated patients. Imfinzi, an immuno-oncology therapy that activates the body's own immune system to fight cancer cells, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. Reviewed under Health Canada's accelerated approval framework, Imfinzi has been granted Notice of Compliance with Conditions (NOC/c) based on tumour response rate and durability of response.

"Typically, patients with advanced bladder cancer begin with standard platinum-containing chemotherapy," said Dr. Sebastien Hotte, Medical Oncologist and Associate Professor, Department of Oncology, McMaster University. "Those who experience progression in their cancer either during or following chemotherapy are left with few other treatment options. Health Canada's approval of Imfinzi offers a new option to those currently living with this disease, or those who may find themselves with limited options in the future."

While often overlooked, bladder cancer is the fifth most common cancer in Canada.(1) Urothelial carcinoma is the most common type of bladder cancer and accounts for more than 90 per cent of all bladder cancers in Canada.(2) An estimated 9,000 Canadians are diagnosed with bladder cancer each year and in 2017 approximately 2,400 Canadians will die from this disease.(3 )

"The high prevalence of bladder cancer among Canadians means this new treatment advancement comes as welcome and exciting news for patients," said Tammy Northam, Executive Director, Bladder Cancer Canada. "Imfinzi's approval provides a much-needed option for those who experience progression of their cancer during treatment - one that could mean more time together with their families."

Health Canada's approval of Imfinzi is based on data from Study 1108. This is a Phase I/II trial that evaluated Imfinzi in patients with locally advanced or metastatic urothelial carcinoma. Patients had progressed while on or after a platinum-containing chemotherapy, including those who progressed within 12 months of receiving therapy in a neoadjuvant or adjuvant setting.(4)

Imfinzi demonstrated responses that occurred early in treatment and were durable, with an objective response rate (ORR) of 17.6 per cent (95% confidence interval [CI]: 12.3; 23.9) in all evaluable patients, regardless of PD-L1 expression status. Based on a secondary endpoint in this single-arm trial, median time to response was six weeks. Among the total 32 responding patients, 15 patients (47%) had ongoing responses of six months or longer and five patients (16%) had ongoing responses of 12 months or longer.(5)

"We are excited to receive approval for Imfinzi as this represents a significant milestone for Canadian patients with locally advanced or metastatic bladder cancer," said Dr. Jamie Freedman, President, AstraZeneca Canada Inc. "Imfinzi marks our first immuno-oncology indication in Canada and is the cornerstone of our extensive immuno-oncology program, bringing us another step closer to our goal of redefining cancer care for Canadian patients."

About Imfinzi (durvalumab)

Imfinzi (durvalumab) is a fully human monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1 and CD80. Durvalumab is also being investigated in the first-line treatment of patients with unresectable and metastatic bladder cancer as a monotherapy and in combination with tremelimumab, a checkpoint inhibitor that blocks CTLA-4, as part of the DANUBE Phase III trial, which had the last patient commence dosing during the first quarter of 2017 (global trial, excluding China). Additional clinical trials are ongoing to investigate durvalumab as monotherapy or in combination with tremelimumab in multiple solid tumours and blood cancers.

The recommended dose of Imfinzi is 10 mg/kg body weight administered as an intravenous infusion over 60 minutes every two weeks as long as clinical benefit is observed or until unacceptable toxicity.(5 )

About AstraZeneca's Approach to Immuno-Oncology (IO)

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body's immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the vast majority of patients.

We are pursuing a comprehensive clinical trial program that includes durvalumab (anti-PD-L1) as monotherapy and in combination with tremelimumab (anti-CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, evaluating PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 675 employees across the country and our AstraZeneca Canada headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at


(1 )Canada Cancer Statistics, 2017. Accessed October 16, 2017, available at: p22
(2 )Canadian Cancer Society, Urothelial Carcinoma. Accessed October 16, 2017. Available at: (
3 )Canada Cancer Society 2017. Bladder cancer statistics. Accessed October 16, 2017, available at: (
4 )Powles, T. 2017 Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma Updated Results From a Phase 1/2 Open-label Study. Accessed October 16, 2017: (
5 )AstraZeneca Canada Inc., IMFINZI® (durvalumab), Product Monograph, Intravenous Infusion, 50 mg durvalumab / mL, 120 mg and 500 mg single-use vials. Accessed October 16, 2017, available at:

SOURCE AstraZeneca