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 plus 5FU plus platin
KEYNOTE-048 (PC vs C ; all population), 2019
  NCT02358031
RCTmHNSCC - L1 - all populationpembrolizumab plus 5 FU plus platinecetuximab plus 5 FU plus platinepatients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC281 / 278some concern
conclusif
  • demonstrated 23 % decrease in deaths (OS) (PE)
  • inconclusive 8 % decrease in progression or deaths (PFS) (PE)
  • suggested 28 % decrease in deaths (OS) (extension)

mHNSCC - L1 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - PDL1 positive

versus cetuximab plus platin plus 5FU
pembrolizumab plus 5FU plus platin
KEYNOTE-048 (PC vs C ; CPS > 1), 2019
  NCT02358031
RCTmHNSCC - L1 - PDL1 positivepembrolizumab plus 5FU plus platinecetuximab plus 5FU plus platinepatients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC242 / 226some concern
conclusif
  • demonstrated 37 % decrease in deaths (OS) (PE)
  • inconclusive 18 % decrease in progression or deaths (PFS) (PE)
KEYNOTE-048 (PC vs C ; CPS > 20), 2019
  NCT02358031
RCTmHNSCC - L1 - PDL1 positivepembrolizumab plus 5FU plus platinecetuximab plus 5FU plus platinepatients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC126 / 110some concern
conclusif
  • demonstrated 40 % decrease in deaths (OS) (PE)
  • suggested 27 % decrease in progression or deaths (PFS) (PE)