The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab, a PD-1 receptor inhibitor, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have experienced disease progression on or after platinum-containing therapy.1
Approval was based on findings from an international, open-label, multi-cohort study, which evaluated 2 doses and schedules of pembrolizumab in 174 patients with recurrent or metastatic head and neck squamous cell carcinoma.
Of those, 16% (95% CI, 11-22) achieved an objective response as determined by an independent review committee.
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Median duration of response was not reached at the time of analysis, but response durations ranged from 2.4 months to 27.7 months. Among the 28 patients who achieved a response, 82% had a response lasting 6 months or longer.
The most common adverse reactions in this patient population were fatigue, decreased appetite, and dyspnea.
The safety profile was similar to that seen with melanoma or non-small cell lung cancer treated with pembrolizumab, though an increased incidence of facial edema and new or worsening hypothyroidism were observed in patients treated for head and neck cancer.
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The recommended dose and schedule of pembrolizumab for head and neck cancer is 200 mg given intravenously over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
Reference
- Pembrolizumab (Keytruda). U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm515627.htm. Updated August 5, 2016. Accessed August 9, 2016.