First-ever Combination of Two Immuno-Oncology Agents for Metastatic Melanoma Approved by Health Canada
Bristol-Myers Squibb receives approval from Health Canada for the OPDIVO® + YERVOY® Regimen for unresectable or metastatic melanoma OPDIVO® + YERVOY® Regimen demonstrates the potential of targeting distinct and complementary immune pathways at the same time
Canadians battling metastatic melanoma have a new treatment option consisting of the first-ever combination of two immuno-oncology agents, with the potential to increase progression-free survival in certain patients. Health Canada has granted conditional approval for the OPDIVO® + YERVOY® Regimen for the treatment of previously untreated adults with unresectable or metastatic melanoma.
Health Canada also issued a Notice of Compliance with conditions for the OPDIVO® monotherapy for the treatment of unresectable or metastatic BRAF V600 mutation-positive melanoma in previously untreated adults.1
An improvement in survival has not yet been established in either indication.1
This latest approval is based on data from the pivotal study, CheckMate -067, which compared progression-free survival and overall survival of OPDIVO® combined with YERVOY® to YERVOY® monotherapy and of OPDIVO® monotherapy to YERVOY® monotherapy in subjects with previously untreated, unresectable or metastatic melanoma. Overall response rate was a secondary objective.1
Checkmate -067 demonstrated that treatment with the combination of OPDIVO® and YERVOY® or with OPDIVO® alone resulted in significantly longer progression-free survival and higher objective response rates than did treatment with YERVOY® alone.1 Relative to OPDIVO® monotherapy, an increase in progression-free survival for the combination of OPDIVO® with YERVOY® is established only in patients with low tumour PD-L1 expression (based on the predefined expression level of < 5 per cent).1
“The approval of the OPDIVO® + YERVOY® Regimen marks another first for Bristol-Myers Squibb’s research in immuno-oncology. As part of our commitment to continually redefine cancer care and improve patient outcomes, we are advancing the science of combination therapy with the aim of delivering the next wave of combination regimens for various advanced cancers.”said Dr. Nawal Peacock, president and general manager, Bristol-Myers Squibb Canada Co. “We have been leading the way since 2012, when our immuno-oncology agent, YERVOY® was approved as the first immune checkpoint inhibitor to significantly improve survival in advanced melanoma. Our second immuno-oncology agent, OPDIVO®, was then approved in 2015.”
“Since the introduction of immuno-oncology treatments for metastatic melanoma, survival expectations have improved for more people with this deadly form of skin cancer,” said Dr. David Hogg, medical oncologist and CheckMate -067 clinical trial investigator in Toronto. “Now we have a new treatment option that combines two immuno-oncology agents, demonstrating significant efficacy. This is good news for patients with metastatic melanoma who may benefit from this novel treatment combination.”
Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. OPDIVO® and YERVOY® are immune checkpoint inhibitors that target separate, distinct and complementary checkpoint pathways (PD-1 and CTLA-4).1 The mechanism of action involves dual immune checkpoint inhibition resulting in increased anti-tumor activity.1 YERVOY’s® blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, while OPDIVO® restores the active T-cell response directed at the tumor.1
“With advances in treatment like immuno-oncology, we are seeing people with metastatic melanoma, a deadly disease, actually surviving,” said Kathy Barnard, Founder of the Save Your Skin Foundation and herself a survivor of metastatic melanoma. “This new treatment combination is yet another advance, one that may help even more patients live longer, to share more time with family, and have more hope for the future.”
“This is an exciting moment for the melanoma community,” said Annette Cyr, Chair and Founder, Melanoma Network of Canada. “Immuno-oncology is making a significant impact in the lives of patients with metastatic melanoma. Now, with new approaches to treating this disease, we are hopeful patients will experience better outcomes and longer survival.”
Melanoma is a type of skin cancer that develops in the cells (melanocytes) that produce melanin – the pigment that gives your skin its colour. Melanoma is one of the most serious forms of skin cancer because it has the potential to metastasize and spread to the lymph nodes as well as distant organs.
When found at an early stage, melanoma has one of the highest cure rates of all cancers at more than 90 per cent. If gone undetected or left untreated, melanoma can start to invade the skin and metastasize.4Metastatic melanoma has only a 10-19 per cent five year survival rate.
More than 6,800 Canadians are estimated to be diagnosed with melanoma in 2016 and 1,200 Canadians will die from melanoma.3 Of the new cancer cases found in young adults aged 15-29, melanoma, is one of the most common types of cancers found.2
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer.
We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents, including the first combination of two I-O agents in metastatic melanoma, and our differentiated clinical development program, which is studying broad patient populations across more than 20 types of cancers with 11 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and inform which patients will benefit most from I-O therapies.
We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.
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. 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 Co. employs over 300 people across the country. For more information, please visit www.bmscanada.ca.
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 Bristol-Myers Squibb. OPDIVO® Canadian Product Monograph. 2016.
 Canadian Cancer Society, Statistics Canada, & Public Health Agency of Canada. (2015, June). Canadian Cancer Statistics 2015. Retrieved October, 2016, from https://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2015-EN.pdf
Canadian Cancer Society. (n.d.). Melanoma statistics. Retrieved October, 2016, from http://www.cancer.ca/en/cancer-information/cancer-type/skin-melanoma/statistics/?region=on
Canadian Cancer Society. (n.d.). What is melanoma. Retrieved October, 2016, from http://www.cancer.ca/en/cancer-information/cancer-type/skin-melanoma/melanoma/?region=on
 Canadian Dermatology Association. (n.d.). Malignant Melanoma. Retrieved October, 2016, from http://www.dermatology.ca/skin-hair-nails/skin/skin-cancer/malignant-melanoma/
Canadian Cancer Society. (n.d.). Survival statistics for melanoma. Retrieved October, 2016, from http://www.cancer.ca/en/cancer-information/cancer-type/skin-melanoma/prognosis-and-survival/survival-statistics/?region=on