Study study type PathologyT1T0Patientssample sizesROB Results deaths (OS) Eprogression or deaths (PFS) ERFS/DFS E

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 -19% 34%

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

versus cetuximab plus platin plus 5FU
pembrolizumab alone
KEYNOTE-048 (P vs C ; CPS > 20), 2019
  NCT02358031
RCTmHNSCC - L1 - PDL1 positivepembrolizumabcetuximab with chemotherapy (platine plus 5FU)patients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC133 / 122some concern
conclusif -32% -1%
KEYNOTE-048 (P vs C ; CPS > 1), 2019
  NCT02358031
RCTmHNSCC - L1 - PDL1 positivepembrolizumabplatinium based chemotherapy (cetuximab plus 5FU and platine)patients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC257 / 255some concern
conclusif -26% 16%

mHNSCC - L2 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - all population

versus Standard of Care (SoC)
pembrolizumab alone
KEYNOTE-040 (all population), 2018
  NCT02252042
RCTmHNSCC - L2 - all populationpembrolizumabchemotherapy (methotrexate, docetaxel or cetuximab)patients with recurrent or metastatic head and neck squamous cell cancer that progressed during or after platinum-containing treatment : all population247 / 248some concern
conclusif demonstrated-20% -4%

mHNSCC - L2 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 positive

versus Standard of Care (SoC)
pembrolizumab alone
KEYNOTE-040 (CPS >1), 2018
  NCT02252042
RCTmHNSCC - L2 - PDL1 positivepembrolizumabchemotherapy (methotrexate, docetaxel or cetuximab)patients with recurrent or metastatic head and neck squamous cell cancer that progressed during or after platinum-containing treatment : only patients with CPS > 1196 / 191some concern
conclusif demonstrated-26% 1%