Results from a recent large trial indicate that treatment with the immunotherapy agent, Opdivo (nivolumab), nearly doubles the survival rate at one year in the treatment of advanced head and neck cancer. These results prompted the United States Food and Drug Administration to grant nivolumab “breakthrough therapy designation” for the treatment of patients with this disease.
Globally, head and neck cancer comprises the seventh most common type of cancer with an estimated 400,000-600,000 diagnoses every year. Metastatic, or stage IV head and neck cancer refers to cancer that has spread from its site of origin to distant sites in the body. Overall survival at 5 years for patients diagnosed with metastatic head and neck cancer is less than 4%, indicating a significant need in improved treatment for patients with this disease.
Nivolumab is an immunotherapy agent that helps restore the immune therapy’s ability to identify cancer cells and ultimately mount an attack against them. It is already approved for treatment for certain types of melanoma, lung cancer, and kidney cancer.
The latest clinical trial evaluating nivolumab in squamous cell head and neck cancer that prompted the new FDA designation is referred to as the CheckMate-141 trial. This trial included patients whose cancer had progressed following prior therapy with platinum agents (a class of chemotherapy agents commonly used in the treatment of head and neck cancer), and had spread from its site of origin. Patients were treated with either nivolumab or standard therapy, and their results were directly compared.
- The median overall survival was 7.5 months for patients treated with nivolumab, compared with 5.1 months for those treated with standard therapy.
- Overall survival at one year was 36% for patients treated with nivolumab, compared with 16.6% for those treated with standard therapy.
- Serious side effects occurred in 13.1% of patients treated with nivolumab, compared with 35.1% of patients treated with standard therapy.
- Among patients who had the human papilloma virus (HPV), which is associated with an increased risk of oropharyngeal cancers, the median overall survival was 9.1 months for those treated with nivolumab, compared to only 4.4 months for those treated with standard therapy.
These results indicate the potential survival benefit of nivolumab among patients with advanced head and neck cancer that has stopped responding to prior platinum therapy. Breakthrough therapy designation underscores the need for advancing therapeutic approaches for patients with this disease.
Bristol-Myers Squibb. First Presentation of Overall Survival Data for Opdivo® (nivolumab) Shows Significant Survival Benefit at One-Year Versus Investigator’s Choice in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck. Available at: http://news.bms.com/press-release/aacr/first-presentation-overall-survival-data-opdivo-nivolumab-shows-significant-survi. Accessed May 1, 2016.
Bristol-Myers Squibb. Bristol-Myers Squibb’s Opdivo® (nivolumab) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck. Available at: http://news.bms.com/press-release/bms/bristol-myers-squibbs-opdivo-nivolumab-receives-breakthrough-therapy-designation-u. Accessed May 1, 2016.
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