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
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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.
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2 OPDIVO Product monograph.
Available at:
https://www.bms.com/assets/bms/ca/documents/productmonograph/OPDIVO_EN_PM.pdf
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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.
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4 Can Urol
Assoc J 2017;11(10):310-20.
http://dx.doi.org/10.5489/cuaj.4769
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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.
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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.
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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.
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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.
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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.
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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
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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
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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
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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.
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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.
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SOURCE Bristol-Myers Squibb