pembrolizumab plus SoC (n=257) vs. placebo plus SoC (n=250)
randomized controlled trial
pembrolizumab plus 5FU or capcitabine plus cisplatine
pembrolizumab (200 mg every 3 weeks) plus chemotherapy (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)
placebo plus 5FU or capcitabine plus cisplatine
pembrolizumab matched placebo plus chemotherapy : 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%)
all patients received chemotherapy => 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 (PC vs C ; CPS>10), 2020 NCT02494583
pembrolizumab plus SoC (n=99) vs. placebo plus SoC (n=90)
randomized controlled trial
pembrolizumab plus chemotherapy (5FU or capecitabine, plus cisplatine)
pembrolizumab (200 mg every 3 weeks)
placebo plus chemotherapy (5FU or capecitabine, plus cisplatine)
pembrolizumab matched placebo plus chemo (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)
all patients received chemotherapy => 3 treatment arms of the study: pembrolizumab (monotherapy) Pembrolizumab plus chemo or placebo
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