Inmunoterapia en el tratamiento del cáncer de cabeza y cuello - page 9

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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 response 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 JuneExit
Disclaimer at the American Society of Clinical Oncology annual meeting by trial investigator Ranee Mehra, M.D.