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. 2021 Feb 12;14(2):151. doi: 10.3390/ph14020151

Table 1.

Overview of immune checkpoint inhibitor clinical trials in oesophago-gastric cancer.

Entity Author Ref. Trial Phase Treatment N Localisation Histology PD-L1 Score Results (Primary
Enpoint, Median)		 Results (Further Analysis, Median)
Oesophageal cancer
Curative Kelly et al. [14] Checkmate-577 III Adjuvant Nivo vs. placebo 794 Oe/GEJ ESCC (30%), EAC (70%) all comers DFS 22.4 vs. 11 months (HR 0.69
(95% CI 96.4% CI 0.56–0.86), p = 0.0003
First-line Kato et al. [15] Keynote-590 III Pembro + Cis/5-FU vs.
Cis/5-FU alone		 749 Oe/GEJ ESCC (73%), EAC (27%) all comers OS all 12.4 vs 9.8 months (HR, 0.73,
95% CI, 0.62–0.86), p < 0.0001		 ORR all 45% vs. 29.3%, p < 0.0001
OS ESCC 12.6 vs. 9.8 months (HR 0.72;
95% CI, 0.60–0.88), p = 0.0006
OS PD-L1 CPS ≥ 10: 13.5 vs. 9.4 months (HR 0.62;
95% CI, 0.49–0.78), p < 0.0001
OS ESCC PD-L1 CPS ≥10 median 13.9 vs. 8.8 mo; (HR 0.57;
95% CI, 0.43–0.75)
PFS all pts 6.3 vs. 5.8 months (HR 0.65;
95% CI, 0.55–0.76), p < 0.0001
PFS ESCC 6.3 vs. 5.8 months (HR 0.65;
95% CI, 0.54–0.78), p < 0.0001
PFS CPS ≥10: 7.5 vs. 5.5 months (HR 0.51;
95% CI, 0.41–0.65) p < 0.0001
Second-line Kojima et al. [16] Keynote-181 III Pembro vs. Pacli/Doce/Irino 628 Oe/GEJ ESCC (64%), EAC (36%) all comers OS all 7.1 vs. 7.1 months (HR 0.89;
95% CI, 0.75–1.05), p = 0.0560
OS ESCC 8.2 vs. 7.1 months (HR 0.78;
5% CI, 0.63–0.96), p = 0.0095
OS CPS ≥ 10: 9.3 vs. 6.7 months (HR 0.69;
95% CI, 0.52–0.93), p = 0.0074
Kato et al. [17] Attraction-03 III Nivo vs. Pacli/Doce 419 Oe ESCC all comers OS 10.9 vs. 8.4 months (HR 0.77,
95% CI 0.62–0.96), p = 0.019
GEJ/Stomach cancer
Curative Al-Batran et al. [18] Dante II Atezo + FLOT vs. FLOT alone 295 GEJ/GC Adenocarcinoma all comers DFS (awaited) Rate of pathological regression (awaited)
First-line Moehler et al. [22] Checkmate-649 III Nivo + XELOX/FOLFOX vs. Nivo + Ipi vs. Chemo alone 1581 GEJ/GC Adenocarcinoma all comers OS PD-L1 CPS ≥ 5: 14.4 vs. 11.1 months,
HR 0.71 (98.4% CI 0.59–0.86), p < 0.0001		 OS all 13.8 vs. 11.6 months
(HR 0.80; 99.3% CI 0.68–0.94), p = 0.0002
(60% PD-L1 CPS ≥ 5) PFS PD-L1 CPS ≥ 5: 7.7 vs. 6.0 months;
HR (98% CI 0.56–0.81), p < 0.0001		 OS PD-L1 CPS ≥ 1: 14.0 vs. 11.3 months,
HR 0.77 (99.3% CI 0.64–0.92), p = 0.0001
PFS all 7.7 vs. 6.9 months;
HR 0.77 (95% CI 0.68–0.87), p > 0.05
PFS PD-L1 CPS ≥1: 7.5 vs. 6.9 months;
HR 0.74 (95% CI 0.65–0.85), p > 0.05
Shitara et al. [20] Keynote-062 III Pembro vs. Cis/5-FU or Cape;
(p/p + c/placebo + c)		 763 GEJ/GC Adenocarcinoma PD-L1 CPS ≥ 1 OS PD-L1 CPS ≥1: 10.6 vs. 11.1 months;
HR 0.74 (95% CI 0.74–1.10), p = 0.162,
p non inferior to c
OS PD-L1 CPS ≥10: 17.4 (p) vs 10.8
months (c); HR 0.69 (95% CI 0.49–0.97)
OS PD-L1 CPS ≥1: 12.5 (p + c) vs. 11.1
months (c); HR 0.85 (95% CI 0.7–1.03), p = 0.046, p + c not superior
OS PD-L1 CPS ≥10: 12.3 (p + c) vs. 10.8
months (c): HR 0.85 (0.62–1.17), p = 0.158, p + c not superior
PFS PD-L1 CPS ≥1: 6.9 (p + c) vs. 6.4
months (c): HR 0.84 (0.70–1.02), p = 0.04
Second-line Shitara et al. [24] Keynote-061 III Pembro vs. Pacli 592 GEJ/GC Adenocarcinoma all comers (67% PD-L1 CPS ≥ 1) OS PD-L1 CPS ≥1: 9.1 vs. 8.3 months;
HR 0.81 (95% CI 0.66–1.00), p > 0.05		 OS PD-L1 CPS ≥ 5: 10.4 vs. 8.3 months;
HR 0.72 (95% CI 0.53–0.99), p > 0.05
PFS PD-L1 CPS ≥1: 1.5 vs. 4.1 months;
HR 1.27 (95% CI 1.03–1.57)		 OS PD-L1 CPS ≥ 10: 10.4 vs. 8.0 months;
HR 0.69 (95% CI 0.46–1.05), p > 0.05
Thuss-Patience et al. [27] RAP II Ram + Avel + Pacli, single arm 60 GEJ/GC Adenocarcinoma all comers OSR at 6 months (awaited) OS, OSR at 12 months, PFS, DoR (awaited)
Moehler et al. [21] Javelin Gastric-100 II Avel vs. maintainance 1st line 499 GEJ/GC Adenocarcinoma all comers OS all 10.4 vs. 10.9 months; HR 0.91
(95% CI 0.74–1.11), p = 0.1779; 		ORR 13.3% (95% CI 9.3–18.1) vs. 14.4%
(95% CI 10.3–19.4)
OS PD-L1 + (n = 54): HR 1.13
(95% CI 0.57–2.23)		 DOR (12 months): 62.3% (95% CI 40.9–77.9)
vs. 28.4% (95% CI 13.2–45.7)
Third-line Kang et al. [30] Attraction-02 III Nivo vs. placebo 493 GEJ/GC Adenocarcinoma all comers OS 5.3 vs. 4.14 months; HR 0.63 (95%
CI 0.51–0.78), p < 0.0001)
Fuchs et al. [29] Keynote-059 II Pembro mono 259 GEJ/GC Adenocarcinoma all comers ORR PD-L1+/-: 15.5% (95% CI, 10.1–22.4%)
vs. 6.4% (95% CI 2.6%–12.8%)		 Response duration PD-L1+/-:
16.3 months (95% CI 1.6–17.3) vs.
6.9 months (95% CI 2.4–7.0)
HER2 positive cancer
First-line Tintelnot et al. [36] Intega II Ipi/FOLFOX + Nivo + Tmab 97 GEJ Adenocarcinoma all comers OS (awaited) PFS, ORR (awaited)
Janjigian et al. [33] Pembro + Tmab II Pembro + Tmab + chemo (Oxali/Cis + Cape/5-FU)
Single-arm		 37 Oe/GEJ/GC Adenocarcinoma all comers PFS 6 months: 70% (95% CI 54–83);
mPFS 13.0 months (95% CI 8.6-NR)		 OS 27.3 months (95% CI 18.8-NR),
12 months OSR: 80% (95% CI 68–95)
Treatment duration: 10 months
(IQR 5.7–13.7)

Nivo = Nivolumab, Ipi = Ipilimumab, Pembro = Pembrolizumab, Atezo = Atezolizumab, Avel = Avelumab, Ram = Ramucirumab, Tmab = Trastuzumab, Pacli = Paclitaxel, Doce = Docetaxel, Irino = Irinotecan, Cis = Cisplatin, Cape = Capecitabine, Oxali = Oxaliplatin, Oe = Oesophagus, GEJ = gastrointestinal junction, GC = gastric cancer, OS = overall survial, ORR = overall response rate, PFS = progression free survival, PFSR = progression free survival rate, DFS = disease-free survival, HR = Hazard ratio, IQR = interquartile range, NR = not reached.