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)
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 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
  • demonstrated 39 % decrease in deaths (OS) (PE)
  • inconclusive 1 % decrease in progression or deaths (PFS) (PE)
  • suggested 42 % decrease in deaths (OS) (extension)
  • statistically significant 89 % decrease in objective responses (ORR)
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
  • demonstrated 22 % decrease in deaths (OS) (PE)
  • inconclusive 16 % increase in progression or deaths (PFS) (PE)
  • suggested 26 % decrease in deaths (OS) (extension)
  • statistically significant 56 % decrease in objective responses (ORR)
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
  • demonstrated 40 % decrease in deaths (OS) (PE)
  • suggested 27 % decrease in progression or deaths (PFS) (PE)
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)

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

versus Standard of Care (SoC)
durvalumab alone
EAGLE (D vs ICC), 2019
  NCT02369874
RCTmHNSCC - L2 - all populationdurvalumabinvestigator’s choice: cetuximab, taxane, methotrexate, or fluoropyrimidine-based regimenpatients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).of the oral cavity, oropharynx, hypopharynx, or larynx not amenable to curative therapy who had progression or recurrence during or after only one systemic treatment regimen containing a platinum agent240 / 249some concern
inconclusive
  • inconclusive 12 % decrease in deaths (OS),deaths (OS) (PE)
durvalumab plus tremelimumab
EAGLE (DT vs ICC), 2019
  NCT02369874
RCTmHNSCC - L2 - all populationdurvalumab plus tremelimumabinvestigator’s choice: cetuximab, taxane, methotrexate, or fluoropyrimidine-based regimenpatients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).of the oral cavity, oropharynx, hypopharynx, or larynx not amenable to curative therapy who had progression or recurrence during or after only one systemic treatment regimen containing a platinum agent247 / 249some concern
inconclusive
  • inconclusive 4 % increase in deaths (OS),deaths (OS) (PE)
nivolumab alone
CheckMate 141, 2016
  NCT02105636
RCTmHNSCC - L2 - all populationnivolumabICC (methotrexate, docetaxel or cetuximab)patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy240 / 121some concern
conclusif
  • demonstrated 30 % decrease in deaths (OS) (PE)
  • suggested 32 % decrease in deaths (OS) (extension)
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 % decrease in deaths (OS) (PE)

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

versus durvalumab alone
durvalumab plus tremelimumab
CONDOR (DT vs D ; PDL1 TC<25%), 2019
  NCT02319044
RCTmHNSCC - L2 - PDL1 negativedurvalumab plus tremelimumabdurvalumab monotherapypatients with recurrent or metastatic HNSCC (PD-L1-low/negative) that had progressed after 1 platinum-containing regimen in the R/M setting133 / 67high
inconclusive
  • inconclusive 17 % decrease in objective responses (ORR) (PE)
  • statistically significant 8.4-fold increase in STRAE (any grade)
versus tremelimumab
durvalumab plus tremelimumab
CONDOR (DT vs T ; PDL1 TC<25%), 2019
  NCT02319044
RCTmHNSCC - L2 - PDL1 negativedurvalumab plus tremelimumabtremelimumab monotherapypatients with recurrent or metastatic HNSCC (PD-L1-low/negative) that had progressed after 1 platinum-containing regimen in the R/M setting133 / 67high
suggested
  • inconclusive 4.2-fold increase in objective responses (ORR) (PE)

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 % decrease in deaths (OS) (PE)