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The FDA granted

accelerated approval

based on early data from 174 patients with HNSCC enrolled in the

nonrandomized KEYNOTE-012 trial. These patients had HNSCC that continued to grow and spread despite treatment

with a platinum-containing chemotherapy; the majority of patients in the trial previously had received at least two

different courses of treatment.

According to the

FDA approval summary ,

28 patients (16%) experienced a tumor


following treatment with

pembrolizumab. In 23 (82%) of those patients, the tumor response lasted for 6 months or longer, and several have

lasted for more than 2 years.

Several patients in the trial had a

complete response ,

according to

data from the trial presented in JuneE xit Disclaimer

at the American Society of Clinical Oncology annual meeting by trial investigator Ranee Mehra, M.D., of Fox Chase

Cancer Center.