HEALTH CANADA APPROVES OPDIVO®(NIVOLUMAB) FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
product-approval , Opdivo
Health Canada has approved OPDIVO® (nivolumab) for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy– the first and only immuno-oncology treatment in Canada for this indication.Immuno-oncology uses the body’s own immune system to fight cancer cells.
“Head and neck cancers can have devastating consequences for patients and their families. Traditional risk factors that include tobacco and alcohol consumption and the increasingly important role of Human Papilloma Virus (HPV) infection are leading to worrisome increases in oropharyngeal SCCHN,” said Dr. John Walker, assistant professor of oncology, University of Alberta. “The approval of OPDIVO® is an important advance for patients with cancers of the head and neck that have high unmet need and limited treatment options.”
The data to support the approval was based on CheckMate -141, a phase three clinical trial that was stopped early when an independent data review showed the study met its primary endpoint, demonstrating superior overall survival (OS) in patients receiving OPDIVO® compared to the control arm.
OPDIVO® has now been approved in four distinct tumour types within the last 18 months in Canada. It was first approved in September 2015 for the treatment of adult patients with metastatic BRAF V600 wild-type melanoma; followed by approval for locally advanced or metastatic non-small cell lung cancer (NSCLC) in February 2016 and renal cell carcinoma (RCC), a form of kidney cancer in April 2016.
Head and neck cancers include oral cavity, larynx/hypopharynx and salivary gland cancers, which affect thousands of Canadians and represent a large worldwide burden of disease because treatment can impact an individual’s ability to breathe, speak and swallow.According to statistics, oral cavity cancer (including the oropharynx subsite), for instance, is the 13th most common newly diagnosed cancer and the 15th most common cause of death due to cancer for adults. The five year survival rate for head and neck cancers is reported as less than four percent for metastatic Stage IV disease.
About CheckMate -141
CheckMate -141 was a Phase 3, open-label, randomized study of OPDIVO® versus investigator’s choice of therapy in previously treated patients with SCCHN who have tumor progression on or within six months of platinum therapy in the primary, recurrent, or metastatic setting. The trial randomized 361 patients 2:1 to receive either OPDIVO® 3 mg/kg intravenously every two weeks or investigator’s choice (cetuximab/methotrexate/docetaxel) until documented disease progression or unacceptable toxicity. The primary endpoint was OS. Secondary endpoints included objective response rate and progression free survival.
“Our Canadian team has been committed to working together for patients to transform survival expectations,” said Dr. Nawal Peacock, president and general manager, Bristol-Myers Squibb Canada Co. “Health Canada’s latest approval of OPDIVO® for cancer of the head and neck is a testament of our success in advancing the OPDIVO® clinical development program in hard-to-treat cancers. This newest advancement will offer hope for longer survival tomore patients suffering from head and neck cancers.”
OPDIVO® is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, OPDIVO® has become an important treatment option across multiple cancers.
OPDIVO®’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of immuno-oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the OPDIVO® clinical development program has enrolled more than 25,000 patients. The OPDIVO® trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from OPDIVO® across the continuum of PD-L1 expression.
In July 2014, OPDIVO® was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. OPDIVO® is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s OPDIVO® and YERVOY®combination regimen was the first immuno-oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including Canada, the United States and the European Union.
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 35 types of cancers with 13 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, immunoscience and virology for over 80 years. Bristol-Myers Squibb Canada Co. employs 300 people across the country. For more information, please visit www.bmscanada.ca.