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)
KEYNOTE-040 (CPS >1), 2018 NCT02252042
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)