Trial Study arms Efficacy Outcomes References
CheckMate 649
n=1,581; phase III trial,
metastatic patients with esophageal, gastric or GEJ cancers,
first-line
CTx (Capecitabine plus oxaliplatin or FOLFOX)
vs
CTx (Capecitabine plus oxaliplatin or FOLFOX) with Nivolumab
vs
Nivolumab plus Ipilimumab
ORR: 45% vs 60%; p<0.0001

mPFS: 6.1 months vs 7.7 months; p<0.0001

mOS: CPS ≥5: 11.1 months;
All patients:
11.6 months vs CPS ≥5: 14.4 months, p<0.0001;
All patients:
13.8 months, p=0.0002
[@97990]
ATTRACTION-4
n=724; phase II trial, metastatic Asian G/GEJ cancer patients, first-line
CTx (S-1 or capecitabine plus oxaliplatin) vs CTx (S-1 or capecitabine plus oxaliplatin) with nivolumab ORR: 47.8% vs 57.5%; p=0.0088

mPFS: 8.34 months vs 10.45 months; p=0.0007

mOS: 17.15 months vs 17.45 months; p=0.26
[@97992]
KEYNOTE-590,
n=749; phase III trial locally advanced unresectable or metastatic squamous cell carcinoma (SCC) or adenocarcinoma (AC) of the esophagus
Pembrolizumab plus chemotherapy (5-FU plus cisplatin) vs placebo plus chemotherapy ORR: 45% vs 29.3%

mOS: CPS ≥10: 13.9 months vs 8.8 months;

all ESCC: 12.6 months vs 9.8 months
[@97995]
CheckMate 648
n=970; phase III trial,
patients with metastatic and untreated ESCC
Nivolumab plus chemotherapy (5-FU plus cisplatin), vs the combination of nivolumab plus ipilimumab vs chemotherapy mOS: nivolumab plus chemotherapy versus chemotherapy alone in PD-L1 ≥1% population: 15.4 months vs 9.1 months; p<0.0001 [@97996]
DESTINY-Gastric01
n=188; phase II trial, HER2+ Asian metastatic gastric cancer patients, third- or later-line
CTx (irinotecan or paclitaxel) vs trastuzumab deruxtecan ORR: 14% vs 51%; p<0.001

mPFS: 3.5 months vs 5.6 months; p=0.01
mOS: 8.4 months vs 12.5 months; p=0.01
[@97997]