pembrolizumab alone (n=133) vs. cetuximab plus platin plus 5FU (n=122)
randomized controlled trial
pembrolizumab
pembrolizumab (200 mg) was administered once every 3weeks (max 35 cycles)
cetuximab with chemotherapy (platine plus 5FU)
cetuximab (400 mg/m2 loading dose, then 250 mg/m2 per week) with chemotherapy : carboplatin (area under the curve 5 mg/m2) or cisplatin (100 mg/m2) and 5fluorouracil (1000 mg/m2 per day for 4 consecutive days) every 3 weeks for six cycles
patients receiving the comparator may switch to another anti PD-1 treatment following confirmation of progressive disease, adjustment for the effect of crossover on OS may be performed
mHNSCC - L1 - PDL1 positive
open-label
200 sites in 37 countries
P3 / one-sided test procedure with TWO interim analysis. Repartition and hierarchy between interim analysis and endpoints : 14 hypothesis (primary and secondary)
First-line therapy with pembrolizumab monotherapy significantly improved overall survival in the PD-L1 CPS of 20 or more and CPS of 1 or more populations, and had non-inferior overall survival in the total population
KEYNOTE-048 (P vs C ; CPS > 1), 2019 NCT02358031
pembrolizumab alone (n=257) vs. cetuximab plus platin plus 5FU (n=255)
randomized controlled trial
pembrolizumab
pembrolizumab (200 mg) was administered once every 3weeks (max 35 cycles)
platinium based chemotherapy (cetuximab plus 5FU and platine)
cetuximab (400 mg/m2 loading dose, then 250 mg/m2 per week) with chemotherapy : carboplatin (area under the curve 5 mg/m2) or cisplatin (100 mg/m2) and 5fluorouracil (1000 mg/m2 per day for 4 consecutive days) every 3 weeks for six cycles
patients receiving the comparator may switch to another anti PD-1 treatment following confirmation of progressive disease, adjustment for the effect of crossover on OS may be performed
mHNSCC - L1 - PDL1 positive
open-label
200 sites in 37 countries
P3 / one-sided test procedure with TWO interim analysis. Repartition and hierarchy between interim analysis and endpoints : 14 hypothesis (primary and secondary)
First-line therapy with pembrolizumab monotherapy significantly improved overall survival in the PD-L1 CPS of 20 or more and CPS of 1 or more populations, and had non-inferior overall survival in the total population