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%
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 -14% -8%

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%
pembrolizumab plus 5FU plus platin
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 -41% -27%
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 -26% -18%

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%

 

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