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

OPDIVO® (nivolumab) + YERVOY® (ipilimumab) combination is the first and only treatment to show significantly superior overall survival versus current standard of care in intermediate- and poor-risk advanced or metastatic renal cell carcinoma¹

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.

In Canada, the five-year net survival rate for kidney cancers is reported at 67 per cent.¹² Advanced RCC data is not available in Canada, but results from the U.S. state that only 36 per cent of patients with advanced RCC survive beyond one year, and between 8 and 12 per cent will live past five years.^13,14

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. For more information about Bristol-Myers Squibb global operations, visit www.bms.com. Bristol-Myers Squibb Canada Co. delivers innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, and immunoscience. Bristol-Myers Squibb Canada Co. employs more than 300 people across the country. For more information, please visit www.bmscanada.ca.

References

¹ Motzer R, Tannir N,  McDermott D, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018;378(14):1277-1290.

² OPDIVO Product monograph. Available at:  https://www.bms.com/assets/bms/ca/documents/productmonograph/OPDIVO_EN_PM.pdf

³ DL Stanculeanu, Zob Daniela, A Lazescu, R Bunghez and R Anghel. Development of new immunotherapy treatments in different cancer types. J Med Life v.9(3); Jul-Sep 2016. 

⁴ Can Urol Assoc J 2017;11(10):310-20. http://dx.doi.org/10.5489/cuaj.4769

⁵ Kidney Cancer Canada. A Guide to Kidney Cancer. Available at: https://www.kidneycancercanada.ca/for-patients-and-caregivers/a-guide-to-kidney-cancer/. Accessed on May 29, 2018.

⁶ Motzer R, Tannir N,  McDermott D, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018;378(14):1277-1290.

⁷ Motzer R, Tannir N,  McDermott D, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018;378(14):1277-1290.

⁸ Escudier B, Tannir N, McDermott D, et al. CheckMate 214: efficacy and safety of nivolumab plus ipilimumab vs sunitinib for treatment-naïve advanced or metastatic renal cell carcinoma, including IMDC risk and PD-L1 expression subgroups. Presentation at: European Society of Medical Oncology Annual Meeting; September, 2017; Madrid, Spain.

⁹ Motzer R, Tannir N, McDermott D, et al. Nivolumab + ipilimumab (N+I) vs sunitinib (S) for treatment‐naïve advanced or metastatic renal cell carcinoma (aRCC): results from CheckMate 214, including overall survival by subgroups. Presentation: Society for Immunotherapy of Cancer Annual Meeting; November, 2017; National Harbor, Maryland.

¹⁰ Canadian Cancer Statistics 2018. Available at: http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2018-EN.pdf?la=en  

¹¹ Canadian Cancer Statistics 2018. Available at: http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2018-EN.pdf?la=en

¹² Canadian Cancer Society 2018. Kidney cancer. Available at: http://www.cancer.ca/en/cancer-information/cancer-type/kidney/prognosis-and-survival/survival-statistics/?region=on

¹³ American Cancer Society. Survival Rates for Kidney Cancer by Stage.  https://www.cancer.org/cancer/kidney-cancer/detection-diagnosis-staging/survival-rates.html. Accessed May 30, 2018.

¹⁴ Surveillance, Epidemiology, and End Results Program. Kidney and Renal Pelvis Cancer SEER Survival Rates by Time Since Diagnosis, 2003-2013 By Stage at Diagnosis. National Cancer Institute.

SOURCE Bristol-Myers Squibb

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