Study study type PathologyT1T0Patientssample sizesROB Results

mHNSCC - L1 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - all population

versus cetuximab plus platin plus 5FU
pembrolizumab alone
KEYNOTE-048 (P vs C ; all population), 2019
  NCT02358031
RCTmHNSCC - L1 - all populationpembrolizumabcetuximab with chemotherapy (platine plus 5FU)patients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC301 / 300some concern
inconclusive
  • suggested 17 % decrease in deaths (OS) (PE)
  • statistically significant 34 % increase in progression or deaths (PFS) (PE)
  • statistically significant 64 % decrease in objective responses (ORR)