Results from a recent large trial indicate that treatment with the immunotherapy agent Opdivo® (nivolumab) nearly doubles the survival rate at one year in patients with advanced head and neck squamous cell carcinoma. These results prompted the United States Food and Drug Administration to grant Opdivo “breakthrough therapy designation” for the treatment of patients with this disease.1,2
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.
Opdivo and Keytruda® (pembrolizumab) belong to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to help the immune system recognize and attack cancer. PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1 enhance the ability of the immune system to fight cancer. Both Opdivo and Keytruda work by blocking PD-1 and have demonstrated impressive activity in the treatment of melanoma, kidney, and lung cancers. These PD-1 inhibitors both appear to represent a significant advance in the treatment of head and neck cancers. Results from the clinical trial known as KEYNOTE-012 evaluating the PD-1 inhibitor Keytruda were recently published and demonstrated that the drug is very active in the treatment of recurrent or metastatic head and neck squamous cell carcinoma cancer.3,4
This latest study evaluating Opdivo 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 Opdivo or standard therapy, and their results were directly compared.
- The median overall survival was 7.5 months for patients treated with Opdivo, compared with 5.1 months for those treated with standard therapy.
- Overall survival at one year was 36% for patients treated with Opdivo, compared with 16.6% for those treated with standard therapy.
- Serious side effects occurred in 13.1% of patients treated with Opdivo, 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 Opdivo, compared to only 4.4 months for those treated with standard therapy.
These results are promising and consistent with previous reports demonstrating significant activity of PD-1 inhibitors in patients with advanced head and neck cancer. Keytruda is currently under priority review by the FDA as a treatment for patients with metastatic head and neck squamous cell carcinoma following a platinum-based chemotherapy.
- 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: https://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: https://news.bms.com/press-release/bms/bristol-myers-squibbs-opdivo-nivolumab-receives-breakthrough-therapy-designation-u. Accessed May 1, 2016.
- Seiwert TY, Haddad RI, Gupta S, et al. Antitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion cohort. Journal of Clinical Oncology. 33, 2015 (supplement; abstract LBA6008).
- Seiwert TY, Barbara Burtness B, Weiss J, et al. A phase Ib study of MK-3475 in patients with human papillomavirus (HPV)-associated and non-HPV–associated head and neck (H/N) cancer. Journal of Clinical Oncology. 32:5s, 2014 (supplement; abstract 6011).
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