The immunotherapy Keytruda® (pembrolizumab) appears active in the treatment of advanced squamous cell head and neck cancer. These findings were presented at 2015 Annual Meeting of the American Society of Clinical Oncology (May 29–June 2, Chicago, Illinois) and published in the Journal of Clinical Oncology.[i]

Head and neck cancers originate in the tissues in or around the mouth, nose, and throat. Risk factors for head and neck cancer include smoking, alcohol consumption, and infection with high-risk types of human papillomavirus (HPV). Patients with head and neck cancer that has spread to other parts of the body or that has returned after initial treatment have limited treatment options, and researchers continue to explore new and more effective approaches to treatment.

Keytruda works by blocking the action of a protein called PD-1. Because PD-1 inhibits certain types of immune responses, drugs that block it may enhance the ability of the immune system to fight cancer. Keytruda is approved for the treatment of certain types of metastatic melanoma and may also be active against head and neck cancer.

According to researchers with a clinical trial known as KEYNOTE 012, Keytruda appeared active in a type of recurrent or metastatic head and neck cancer that originates in cells known as squamous cells. Patients received Keytruda at a dose of 10 mg/kg every two weeks. Those who tested positive for tumor biomarkers that indicated the presence of PD-L1—a ligand (or molecule) of the protein that Keytruda inhibits—had 20% response rate to treatment.[ii]

As part of additional research with the KEYNOTE 012 study, researchers gave patients 200 mg of Keytruda every three weeks. They did not take into account PD-L1 expression when they evaluated results (meaning that study outcomes include patients with tumors that were positive and negative for PD-L1). Patients were monitored with X-rays every two months. This research included 132 patients with recurrent or metastatic squamous cell head and neck cancer. The current results include 99 of these patients.

Of the 99 patients evaluated, 18% responded to treatment with Keytruda. Of these patients, 18 patients had a partial response and 31% had stable disease.

Almost half of all participating patients experienced side effects related to treatment with Keytruda. Side effects tended to be mild and included fatigue, decreased appetite, fever, and rash.

According to these findings, a 200 mg dose Keytruda every three weeks appears active in the treatment of recurrent or metastatic squamous cell head and neck cancer. In addition, the drug is well tolerated.


[i] 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).

[ii] 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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