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pembrolizumab alone (n=301) vs. cetuximab plus platin plus 5FU (n=300)
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 (57%) (area under the curve 5 mg/m2) or cisplatin (43%) (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 - all population
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
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
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
pembrolizumab alone (n=247) vs. Standard of Care (SoC) (n=248)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg every 3 weeks intravenously
chemotherapy (methotrexate, docetaxel or cetuximab)
standard treatment per week (methotrexate, docetaxel or cetuximab) methotrexate (26.2%) 40 mg/m2 intravenously (could be increased to 60 mg/m2), docetaxel (44.4%)75 mg/m2 every 3 weeks intravenously, or cetuximab (29.4%) 250 mg/m2
There was no planned crossover on disease progression.
mHNSCC - L2 - all population
open-label
97 medical centres in 20 countries.
P3/ one-sided test procedure with two interim analysis. Hierarchy and split between secondary endpoints : one sided 0.025
pembrolizumab provides a clinically meaningful overall survival benefit compared with investigator’s choice of methotrexate, docetaxel, or cetuximab in patients with recurrent or metastatic head- and-neck squamous cell carcinoma that progressed during or after platinum-based therapy (in all population and CPS>1)
pembrolizumab alone (n=196) vs. Standard of Care (SoC) (n=191)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg every 3 weeks intravenously
chemotherapy (methotrexate, docetaxel or cetuximab)
standard treatment per week (methotrexate, docetaxel or cetuximab) methotrexate (26.2%) 40 mg/m2 intravenously (could be increased to 60 mg/m2), docetaxel (44.4%)75 mg/m2 every 3 weeks intravenously, or cetuximab (29.4%) 250 mg/m2 (% for ITT population)
There was no planned crossover on disease progression.
mHNSCC - L2 - PDL1 positive
open-label
97 medical centres in 20 countries.
P3/ one-sided test procedure with two interim analysis. Hierarchy and split between secondary endpoints : one sided 0.025
pembrolizumab provides a clinically meaningful overall survival benefit compared with investigator’s choice of methotrexate, docetaxel, or cetuximab in patients with recurrent or metastatic head- and-neck squamous cell carcinoma that progressed during or after platinum-based therapy (in all population and CPS>1)
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