The FDA grantedaccelerated 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 theFDA approval summary ,
28 patients (16%) experienced a tumorresponse
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 acomplete response ,
according todata 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