pembrolizumab alone (n=92) vs. placebo plus SoC (n=90)
randomized controlled trial
pembrolizumab
pembrolizumab (200 mg every 3 weeks)
placebo plus chemotherapy (cisplatin plus fluorouracil or capecitabine)
cisplatin 80 mg/m2/d on day 1 plus fluorouracil 800 mg/m2/d on days 1-5 or capecitabine 1000 mg/m2 twice daily on days 1-14 every 3 weeks (no % for this sub-population)
3 treatment arms of the study: pembrolizumab (monotherapy) Pembrolizumab plus chemo or placebo plus chemo
mGC or mGEJC - L1 - PDL1 positive
Patients had to have tumors that were ERBB2 negative with a PD-L1 CPS of 1 or greater for randomization
partially blind
200 sites in 29 countries
P3/ one sided and two interim analysis. The first 4 hypothesis were tested in parallel and then a hierarchical test procedure with reallocation with (P vs C) OS CPS>1 and CPS > 10, and (PC vs C) ORR CPS>1
Monotherapy demonstrated noninferiority to chemotherapy for OS, combination arm was not found to be superior for OS or PFS compared with chemotherapy alone
KEYNOTE-062 (P vs C ; CPS>1), 2020 NCT02494583
pembrolizumab alone (n=256) vs. Standard of Care (SoC) (n=250)
randomized controlled trial
pembrolizumab
pembrolizumab (200 mg every 3 weeks)
placebo plus chemotherapy (5FU or capecitabine plus cisplatin)
placebo plus cisplatin 80 mg/m2/d on day 1 plus fluorouracil 800 mg/m2/d on days 1-5 or capecitabine 1000 mg/m2 twice daily on days 1-14 every 3 weeks. 5FU (38.0%) and capacitabine (62.0%)
3 treatment arms of the study: pembrolizumab (monotherapy) Pembrolizumab plus chemo or placebo plus chemo
mGC or mGEJC - L1 - PDL1 positive
Patients had to have tumors that were ERBB2 negative with a PD-L1 CPS of 1 or greater for randomization
partially blind
200 sites in 29 countries
P3/ one sided and two interim analysis. The first 4 hypothesis were tested in parallel and then a hierarchical test procedure with reallocation with (P vs C) OS CPS>1 and CPS > 10, and (PC vs C) ORR CPS>1
Monotherapy demonstrated noninferiority to chemotherapy for OS, and combination arm was not found to be superior for OS or PFS compared with chemotherapy alone