Only Immuno-Oncology Combination Therapy Approved by Health Canada as First-Line Treatment for Advanced or Metastatic Renal Cell Carcinoma

MONTREAL, July 9, 2018

MONTREAL, July 9, 2018 /CNW/ - Bristol-Myers Squibb Canada Co. (BMS) today announced that immuno-oncology (I-O) combination therapy OPDIVO (nivolumab) 3mg/kg plus YERVOY (ipilimumab) 1mg/kg for intravenous injections, was approved by Health Canada for the treatment of adult patients with intermediate/poor-risk advanced or metastatic renal cell carcinoma (RCC).²  Immuno-oncology represents the most promising new cancer treatment approach since the development of the first chemotherapies.³ According to the Canadian Kidney Cancer Forum consensus update 2017, I-O therapies will enhance the treatment landscape of RCC.⁴  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.⁵ 

"The incidence of RCC has steadily risen over the past decade and many patients still succumb to this disease," said Dr. Daniel Heng, medical oncologist, Tom Baker Cancer Center and clinical professor at the Cumming School of Medicine, University of Calgary. "For patients with intermediate and poor-risk prognosis which represents the majority of RCC patients, providing a treatment option that can significantly improve survival rates is an important advancement and has the potential to become a new standard of care."  

OPDIVO plus YERVOY Regimen Showed Increase in Overall Survival
The data to support the approval was based on CheckMate 214, a phase three clinical trial demonstrating a significant increase of 37% in overall survival (OS) in the intermediate/poor risk patient population receiving the OPDIVO + YERVOY combination compared to a current standard of care, sunitinib.⁶ The median OS was not yet reached for OPDIVO plus YERVOY (95% CI: 28.2 to not estimable [NE]) and was 25.9 months for sunitinib (95% CI: 22.1 to NE). The Objective Response Rate (ORR) of the combination was 41.6%, including 9.4% of Complete Responses (CR).⁷ The Checkmate 214 data was published in the New England Journal of Medicine in March 2018.^7,8,9

In the study, Grade 3-4 adverse reactions were reported in 46% of OPDIVO plus ipilimumab patients and in 63% of sunitinib patients. Serious adverse reactions occurred in 30% of patients receiving OPDIVO plus ipilimumab and 15% of patients receiving sunitinib.  The most frequent serious adverse reactions reported in at least 1% of patients were diarrhea, pneumonitis, hypophysitis, adrenal insufficiency, colitis, hyponatremia, increased ALT, pyrexia and nausea.

"Six Canadians die every day from advanced stage kidney cancer," says Stephen Andrew, Executive Director Kidney Cancer Canada and a metastatic kidney cancer survivor. "The potential of a first-line immune-oncology combination for advance stage kidney cancer patients in our community transforms the treatment landscape.  This option offers new hope to patients and their caregivers."

RCC is the most common type of kidney cancer
Kidney cancer is a term that encompasses many different types of cancer that can occur in the kidney. Approximately 6,600 Canadians are diagnosed each year, and it is more common in men than women.¹⁰ Kidney cancer in Canada is increasing incidence by about 1.0 per cent per year for both men and women.¹¹ Generally, the earlier kidney cancer is diagnosed and treated, the better the outcome.