Health Canada Approves OPDIVO™ (nivolumab) for the treatment of Advanced or Metastatic Renal Cell Carcinoma

OPDIVO™ is the first and only anti PD-1 immuno-oncology agent in Canada approved for the treatment of advanced or metastatic renal cell carcinoma to deliver significant overall survival

Announcement marks third approval for OPDIVO™ in just over six months, in a third distinct tumour type

MONTREAL, April 25, 2016 /CNW/ - Bristol-Myers Squibb (BMS) Canada Co. today announced that Health Canada has approved OPDIVO™ (nivolumab) injection, for intravenous use, for the treatment of adult patients with a form of kidney cancer, renal cell carcinoma (RCC), who have received prior anti-angiogenic therapy in the advanced or metastatic setting.ⁱ

Today's announcement marks the first and only anti PD-1 immuno-oncology agent in Canada approved for the treatment of advanced or metastatic renal cell carcinoma to deliver significant overall survival in adults with advanced or metastatic RCC versus the current standard of care (everolimus).

This marks the third approval for OPDIVO™ in three distinct tumour types in just over six months. Health Canada approved OPDIVO™ for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy on February 26, 2016, and for the treatment of adult patients with unresectable or metastatic BRAF V600 wild-type melanoma in previously treated adults on September 25, 2015.

The OPDIVO™ melanoma, lung and RCC submissions received priority reviews after meeting the criteria of substantial evidence of clinical effectiveness providing an improved benefit/risk profile over existing therapies. As well, the phase 3 studies for the three tumour types were stopped early by an independent data monitoring committee for demonstrating superior overall survival in patients receiving OPDIVO™ versus standard of care.

RCC is the most common type of kidney cancer, with a low five-year survival rate of just 12 per cent in metastatic patients.ⁱⁱ Approximately 6,200 Canadians are diagnosed each year, and it is more common in men than women.ⁱⁱⁱ

"While the treatment landscape for RCC has improved over the last decade, long-term overall survival has remained elusive for many patients," said Dr. Daniel Heng, medical oncologist at the Tom Baker Cancer Center and clinical associate professor at the Cumming School of Medicine, University of Calgary. "OPDIVO™ provides a significant survival advantage compared to a standard of care, and represents an exciting paradigm shift in the treatment of this type of cancer."

"Immuno-oncology is a revolutionary advance in the treatment of this disease,'' said Dr. Anil Kapoor, uro-oncologist and Professor at McMaster University, and chair of the Kidney Cancer Research Network of Canada. "OPDIVO™ is the first anti-PD-1 agent to deliver significant overall survival to patients with advanced RCC, which is an area of high unmet need. This is an exciting time for patients."

"This is a milestone day for cancer care," said Dr. Nawal Peacock, President and General Manager, Bristol-Myers Squibb Canada Co. "As a company, we continue to lead the way with advances in immuno-oncology with the ultimate goal of improving long term survival in a broad range of cancers. With the approvals for OPDIVO™ in melanoma, lung cancer and RCC, we are able to offer hope for more survival to more patients in Canada. Bristol-Myers Squibb Canada would like to take this opportunity to sincerely thank the patients and physicians who participated in the OPDIVO™ clinical trials."  

As an immuno-oncology (I-O) treatment, OPDIVO™ activates the body's own immune system to attack and kill tumours. It is not only the first and only I-O treatment (anti-PD-1 agent) to deliver significant overall survival to adult patients with advanced or metastatic RCC after prior anti-angiogenic therapy, but also to adult patients with unresectable or metastatic BRAF V600 wild-type melanoma and locally advanced or metastatic non-small cell lung cancer.ⁱ

"Advanced kidney cancer is a challenging malignancy with few durable treatment options," said Heather Chappell, Executive Director Kidney Cancer Canada. "The patient community appreciates each new treatment option as an important step forward towards longer term management of this disease."

About Bristol-Myers Squibb Canada Co.

Bristol-Myers Squibb Canada 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 has been delivering innovative medicines for serious diseases to Canadian patients in the areas of cardiovascular health, oncology, neuroscience, immunoscience and virology for over 80 years. Bristol-Myers Squibb Canada employs over 300 people across the country. For more information, please visit www.bmscanada.ca.

Additional Information:

About CheckMate -025
The data to support Health Canada's approval was based on CheckMate -025, an open-label, randomized Phase 3 study in which patients treated with OPDIVO™ achieved a statistically significant median overall survival (OS) of 25.0 months (95 per cent confidence interval [CI], 21.7 to not estimable) and 19.6 months (95 per cent CI, 17.6 to 23.1) with everolimus, with a 27 per cent reduction in risk of death for OPDIVO™.ⁱ The trial randomized 821 patients to receive either OPDIVO™ 3 mg/kg intravenously every two weeks or everolimus 10 mg tablets by mouth daily until documented disease progression or unacceptable toxicity. The objective response rate was superior in the OPDIVO™ group compared with everolimus (25 per cent vs. 5 per cent; odds ratio, 5.98 [95 per cent CI, 3.68 to 9.72]; P<0.001).ⁱ The safety profile of OPDIVO™ in CheckMate -025 was consistent with prior studies. In the study, the most frequently reported adverse drug-related adverse events (occurring at ≥ 10 percent) in patients receiving OPDIVO™ versus everolimus were fatigue (37 per cent vs. 39 per cent), rash (18 per cent vs. 31 per cent), pruritus (14 per cent vs. 10 per cent), nausea (14 per cent vs. 17 per cent), diarrhea (12 per cent vs. 21 per cent), and decreased appetite (12 per cent vs. 21 per cent).ⁱ Serious adverse drug reactions occurred in 12 per cent of patients receiving OPDIVO™ and 13 per cent of patients receiving everolimus. The most frequent serious adverse reactions reported in at least 1 per cent of patients of patients receiving OPDIVO™ were pneumonitis and diarrhea.ⁱ  

The Checkmate -025 phase 3 study was stopped early in July 2015 because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint of overall survival, demonstrating superior overall survival in patients receiving OPDIVO™ compared to the control arm.

About OPDIVO™

Cancer cells may exploit "regulatory" pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. OPDIVO™ is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells, and blocks the binding of PD-L1 and PD-L2, preventing the PD-1 pathway's suppressive signaling on the immune system, including the interference with an anti-tumor immune response.

OPDIVO™'s broad global development program is based on Bristol-Myers Squibb's understanding of the biology behind Immuno-Oncology. Our company is at the forefront of researching the potential of Immuno-Oncology to extend survival in hard to treat cancers. This scientific expertise serves as the basis for the OPDIVO™ development program, which includes a broad range of Phase 3 clinical trials evaluating overall survival as the primary endpoint across a variety of tumor types. To date, the OPDIVO™ clinical development program has enrolled more than 18,000 patients.

OPDIVO™ was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 46 countries including the United States, Japan, and in the European Union.  In Canada, OPDIVO™ (nivolumab) is indicated for the treatment of adult patients

• With advanced or metastatic renal cell carcinoma who have received prior anti-angiogenic therapy,
• With locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after chemotherapy (Patients with EGFR or ALK genomic tumour aberrations should have disease progression on a therapy for these aberrations prior to receiving OPDIVO™),
• With unresectable or metastatic BRAF V600 wild-type melanoma who have been previously untreated.ⁱ

Bristol-Myers Squibb & Immuno-Oncology: Advancing Modern Oncology Research

At Bristol-Myers Squibb, we have a vision for the future of cancer care that is focused on Immuno-Oncology, now considered a major treatment choice alongside surgery, radiation, chemotherapy and targeted therapies for certain types of cancer.

We have a comprehensive clinical portfolio of investigational and approved Immuno-Oncology agents, many of which were discovered and developed by our scientists. Our ongoing Immuno-Oncology clinical program is looking at broad patient populations, across multiple solid tumors and hematologic malignancies, and lines of therapy and histologies, with the intent of powering our trials for overall survival and other important measures like durability of response. We pioneered the research leading to the first regulatory approval for the combination of two Immuno-Oncology agents, and continue to study the role of combinations in cancer.

We are also investigating other immune system pathways in the treatment of cancer including CTLA-4, CD-137, KIR, SLAMF7, PD-1, GITR, and LAG-3. These pathways may lead to potential new treatment options – in combination or monotherapy – to help patients fight different types of cancers.

Our collaboration with academia, as well as small and large biotech companies, to research the potential of Immuno-Oncology and non-Immuno-Oncology combinations, helps achieve our goal of providing new treatment options in clinical practice. 

At Bristol-Myers Squibb, we are committed to changing survival expectations in hard-to-treat cancers and the way patients live with cancer.

References

ⁱ Bristol-Myers Squibb Canada Co. OPDIVO™ Product Monograph. Revised: April 25, 2016.

ⁱⁱ SEER Cancer Statistics Factsheets: Kidney and Renal Pelvis Cancer. National Cancer Institute. Bethesda, MD. Available at: http://seer.cancer.gov/statfacts/html/kidrp.html. Accessed April 6, 2015.

ⁱⁱⁱ Canadian Cancer Society. Kidney Cancer Statistics http://www.cancer.ca/en/cancer-information/cancer-type/kidney/statistics/?region=on. Accessed on February 5, 2016

SOURCE Bristol-Myers Squibb Canada

For media requests please contact: Monica Flores, Public Affairs Lead, Bristol-Myers Squibb Canada, 514.333.3845, [email protected]; Aislinn Mosher, Public Affairs Manager, Bristol-Myers Squibb Canada, 514-333-2530, [email protected]; Fiona Buchanan, Account Supervisor, GCI Group Canada, 416-486-5921, [email protected]