Immunotherapy Approved for Head and Neck Cancer

Zosia Chustecka


November 11, 2016

A new option is now approved in the United States for patients with head and neck cancer: immunotherapy with the programmed cell death inhibitor nivolumab (Opdivo, Bristol-Myers Squibb).

This the fifth cancer indication for the drug — nivolumab is already approved for use in melanoma, lung cancer, renal cell carcinoma, and Hodgkin's lymphoma.

This is the second immunotherapy to be approved for use in head and neck cancer; pembrolizumab (Keytruda, Merck & Co) was approved for this indication earlier this year.

Specifically, the new indication is for use of nivolumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

In such a patient population, nivolumab significantly improved overall survival when compared with the comparator (investigator's choice of methotrexate, docetaxel, or cetuximab) in the phase 3 CHeckMAte-141 trial. The median overall survival was 7.5 months for nivolumab compared with 5.1 months for investigator's choice (hazard ratio, 0.70; P = .0101) , and the estimates for the 1-year survival rate were 36% with nivolumab vs 16.6% with investigator's choice.

The trial was stopped early after this benefit was shown in a preplanned analysis, as reported by Medscape Medical News.

"These are extraordinary data," lead investigator Maura L. Gillison, MD, PhD, Jeg Coughlin Chair of Cancer Research at the Ohio State University Comprehensive Cancer Center, in Columbus, told Medscape Medical News at that time. "For the first time we have a drug that improves survival in this treatment-refractory patient population."

Since the approval of cetuximab (Erbitux, Eli Lilly) for head and neck cancer 10 years ago, there have been no new agents for these patients, she said.

Results were published in the November 10 issue of The New England Journal of Medicine.

A further analysis of data from this trial has shown a significantly improved quality of life with nivolumab compared with chemotherapy. These new data were presented last month at the annual meeting of the European Society of Medical Oncology, as reported by Medscape Medical News.

"Nivolumab not only prolongs life but it does so while maintaining function and reducing symptoms compared with standard-of-care chemotherapy," commented lead investigator Kevin Harrington, MD, PhD, joint head of the Division of Radiotherapy and Imaging at the Institute of Cancer Research, London, United Kingdom.

"Nivolumab is a kinder treatment that is associated with fewer side effects which can have a negative effect on quality of life," he said in a statement, adding that it "allows patients to function at work and socially and experience less pain and fatigue than with chemotherapy."

In October 2016, the US National Comprehensive Cancer Network updated its clinical practice guidelines to recommend treatment with nivolumab as the only category 1 single-agent therapy for patients with recurrent or metastatic head and neck cancer with disease progression on or after platinum-containing chemotherapy, the manufacturer points out in a press release.

Nivolumab is associated with immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, and other adverse reactions (including infusion reactions and embryo-fetal toxicity), the company notes.

SCCHN accounts for more than 90% of all head and neck cancers, the company notes, and more than 50% of patients with SCCHN present with stage III or higher disease (locally advanced or metastatic), which has higher potential for progression and recurrence. The relative 5-year survival rate for metastatic head and neck cancers is less than 38% and can be as low as 4% for recurrent or metastatic stage IV disease.

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