Health Canada Approves OPDIVO® (nivolumab) as Monotherapy for the Adjuvant treatment of Adults with Urothelial Carcinoma (UC) at High Risk of Recurrence after Undergoing Radical Resection of UC
MONTREAL, QUEBEC – June 28, 2022 – Today, Bristol Myers Squibb Canada (BMS) announced Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for OPDIVO®, as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.[i] OPDIVO® is the first immuno-oncology treatment to bring benefit in the adjuvant setting of UC and represents a potential new standard of care for patients at high risk of disease recurrence.[ii] Unlike traditional cancer therapies that target the tumour directly, immuno-oncology activates the body's own immune system to help recognize and attack cancer cells.[iii]
“For years, patients with muscle-invasive urothelial carcinoma (MIUC) have lived with the unfortunate reality that, despite being diagnosed early enough to have their cancer removed, more than fifty percent face disease recurrence, with few safe and effective treatment options available to improve outcomes in these patients,” said Dr. Wassim Kassouf, Professor, Department of Surgery (Urologic Oncology), McGill University. “The approval of OPDIVO® is particularly important because clinicians now have an immunotherapy option to offer certain patients after surgery, that may reduce the risk of disease recurrence. This approval has the potential to significantly impact the way we treat MIUC in Canada.”
About Urothelial Cancer
Bladder cancer begins when healthy cells in the bladder lining—most commonly urothelial cells—change and grow out of control, forming a mass called a tumor. Urothelial cells also line the renal pelvis and ureters. Cancer that develops in the renal pelvis and ureters is also considered a type of urothelial cancer and is referred to upper tract urothelial carcinoma (UTUC).[iv] Urothelial carcinoma of the bladder (UCB) is the most common malignancy of the urinary tract,[v] and the fifth most common cancer in Canada.[vi] Seventy-seven percent of new cases occur in males, making this the fourth most common cancer for Canadian men.[vii]
“We are pleased to see the approval of a new adjuvant treatment that has the potential to delay disease recurrence or prevent progression of disease. Through this positive decision, patients living with muscle-invasive urothelial carcinoma may have the opportunity for more quality time with their loved ones” said Michelle Colero, Executive Director, Bladder Cancer Canada. “This new treatment option addresses the challenging needs of patients after surgery, while they manage the fear of their cancer returning.”
“We are pleased and proud to have OPDIVO® now approved for the treatment of certain patients diagnosed with urothelial cancer in Canada,” said Troy André, General Manager, BMS Canada. “At BMS, we are committed to the pursuit of innovative therapies that can help improve patients’ quality of life. This approval for OPDIVO® gives us the opportunity to introduce a new post-surgery standard of care, building on our legacy as the first company to bring an immuno-oncology treatment to Canadian patients.”
Clinical Data for Approval
The Health Canada NOC/c was based on CheckMate-274 which is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial evaluating OPDIVO® as an adjuvant treatment in patients who had undergone radical resection of urothelial carcinoma (UC) originating in the bladder or upper urinary tract and were at high risk of recurrence.
Treatment was provided up to one year, or until disease recurrence, toxicity, or withdrawal of consent occurred. The two primary endpoints of the trial were disease-free survival (DFS) among all the patients (intention-to-treat population) and among patients with a tumor programmed death ligand 1 (PD-L1) expression level of 1% or more. The key secondary endpoints include non-urothelial tract recurrence-free survival (NUTRFS), disease-specific survival (DSS) and overall survival (OS).i The trial met its primary endpoint of disease-free survival demonstrating that adjuvant OPDIVO® offers patients a chance to delay or potentially prevent disease recurrence in all randomized patients (intention-to-treat population) and those with a tumor PD-L1 expression level of 1% or more. A positive association was observed between tumor PD-L1 expression and the magnitude of the treatment benefit. An improvement in overall survival has not yet been established.
About Bristol Myers Squibb Canada Co.
Bristol Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol Myers Squibb Canada Co. employs close to 300 people across the country. For more information, please visit https://www.bms.com/ca/en.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
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[i] Health Canada issued a Notice of Compliance with Conditions which notes a positive association was observed between tumor PD-L1 expression and the magnitude of the treatment benefit, however an improvement in overall survival has not yet been established.
[ii] Canadian Product Monograph. June 27, 2022.
[iii] Canadian Cancer Society. Immunotherapy. https://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/chemotherapy-and-other-drug-therapies/immunotherapy/?region=on. Accessed Apr 17, 2022.
[iv] Cancer.Net. Bladder Cancer Guide. https://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed Apr 18, 2022.
[v] Canadian Cancer Society. Cancerous tumours of the bladder. https://cancer.ca/en/cancer-information/cancer-types/bladder/what-is-bladder-cancer/cancerous-tumours#:~:text=Urothelial%20carcinoma,lining%20is%20called%20the%20urothelium). Accessed Apr 17, 2022.
[vi] Canadian Cancer Society. Cancer-specific stats 2021. https://cdn.cancer.ca/-/media/files/research/cancer-statistics/2021-statistics/2021_cancer-specific-stats.pdf?rev=bbadfd869b66415e97be9655a842858c&hash=3E552CE702E1BD7657E4E91FB7BA624B&_ga=2.111238148.1693575665.1650230785-493129280.1646783721. Accessed Apr 17, 2022.
[vii] Government of Canada. Bladder cancer in Canada. https://www.canada.ca/en/public-health/services/publications/diseases-conditions/bladder-cancer-canada.html. Accessed Apr 17, 2022.