Ralph C, et al. (2626. Ralph C, Elkord E, Burt DJ, O’Dwyer JF, Austin EB, Stern PL, et al. Modulation of lymphocyte regulation for cancer therapy: a phase II trial of tremelimumab in advanced gastric and esophageal adenocarcinoma. Clin Cancer Res. 2010;16(5):1662-72, http://dx.doi.org/10.1158/1078-0432.CCR-09-2870. http://dx.doi.org/10.1158/1078-0432.CCR-...
) |
18 |
Tremelimumab 15 mg/kg every 3 months |
Metastatic Second-line |
5.6 (0) |
22.2 |
2.8 |
4.8 |
- |
Bang Y-J, et al. (2727. Bang YJ, Cho JY, Kim YH, Kim JW, Di Bartolomeo M, Ajani JA, et al. Efficacy of Sequential Ipilimumab Monotherapy versus Best Supportive Care for Unresectable Locally Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer. Clin Cancer Res. 2017;23(19):5671-8, http://dx.doi.org/10.1158/1078-0432.CCR-17-0025. http://dx.doi.org/10.1158/1078-0432.CCR-...
) |
114 |
Ipilimumab 10 mg/kg every 3 weeks for 4 doses, then every 12 weeks |
Maintenance after first line |
1.8 (0) |
33.4 |
2.7 |
12.7 |
22.8 |
|
|
Placebo |
|
7.0 (0) |
47.4 |
4.9 |
12.1 |
8.9 |
KEYNOTE-012 (1717. Muro K, Chung HC, Shankaran V, Geva R, Catenacci D, Gupta S, et al. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. Lancet Oncol. 2016;17(6):717-26, http://dx.doi.org/10.1016/S1470-2045(16)00175-3. http://dx.doi.org/10.1016/S1470-2045(16)...
) |
39 |
Pembrolizumab 10 mg/kg every 2 weeks |
Metastatic Previously treated (85%) |
22.0 (0) |
36.1 |
1.9 |
11.4 |
13 |
KEYNOTE-059 (1818. Wainberg ZA, Jalal S, Muro K, Yoon HH, Garrido M, Golan T, et al. KEYNOTE-059 Update: Efficacy and safety of pembrolizumab alone or in combination with chemotherapy in patients with advanced gastric or gastroesophageal (G/GEJ) cancer. Ann Oncol. 2017;28(Suppl.5):LBA28, http://dx.doi.org/10.1093/annonc/mdx440.020. http://dx.doi.org/10.1093/annonc/mdx440....
) Cohort 1 |
259 |
Pembrolizumab 200 mg every 3 weeks |
Metastatic 2+ lines of treatment |
12 (3) |
27 |
2.0 |
5.5 |
18 |
KEYNOTE-059 (1818. Wainberg ZA, Jalal S, Muro K, Yoon HH, Garrido M, Golan T, et al. KEYNOTE-059 Update: Efficacy and safety of pembrolizumab alone or in combination with chemotherapy in patients with advanced gastric or gastroesophageal (G/GEJ) cancer. Ann Oncol. 2017;28(Suppl.5):LBA28, http://dx.doi.org/10.1093/annonc/mdx440.020. http://dx.doi.org/10.1093/annonc/mdx440....
) Cohort 2 |
25 |
Pembrolizumab (200 mg every 3 weeks) + CDDP + fluoropyrimidine |
Metastatic Treatment-naive |
60 (4) |
80 |
6.6 |
13.8 |
16 |
KEYNOTE-059 (1818. Wainberg ZA, Jalal S, Muro K, Yoon HH, Garrido M, Golan T, et al. KEYNOTE-059 Update: Efficacy and safety of pembrolizumab alone or in combination with chemotherapy in patients with advanced gastric or gastroesophageal (G/GEJ) cancer. Ann Oncol. 2017;28(Suppl.5):LBA28, http://dx.doi.org/10.1093/annonc/mdx440.020. http://dx.doi.org/10.1093/annonc/mdx440....
) Cohort 3 |
31 |
Pembrolizumab 200 mg every 3 weeks |
Metastatic Treatment-naive |
26 (7) |
36 |
3.3 |
20.7 |
23 |
Segal NH, et al. (3838. Segal NH, Hamid O, Hwu W, Massard C, Butler M, Antonia S, et al. A Phase 1 Multi-arm Dose-expansion Study of the Anti-programmed Cell Death-ligand-1 (PD-L1) Antibody MEDI4736: Preliminary Data. Ann Oncol. 2014;25(Suppl 4):iv365, http://dx.doi.org/10.1093/annonc/mdu342.11. http://dx.doi.org/10.1093/annonc/mdu342....
) |
28 |
Durvalumab 10 mg/kg every 2 weeks |
Previously treated |
7.0 (-) |
25.0 |
- |
- |
- |
JAVELIN (2323. Chung HC, Arkenau H-T, Wyrwicz L, Oh DY, Lee KW, Infante JR. Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced gastric or gastroesophageal junction cancer from JAVELIN solid tumor phase Ib trial: Analysis of safety and clinical activity [abstract]. J Clin Oncol. 2016;34(15 Suppl):4009.) |
62 |
Avelumab 10 mg/kg every 2 weeks |
Metastatic Second-line |
9.7 (0) |
29 |
1.5 |
- |
9.9 |
JAVELIN (2323. Chung HC, Arkenau H-T, Wyrwicz L, Oh DY, Lee KW, Infante JR. Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced gastric or gastroesophageal junction cancer from JAVELIN solid tumor phase Ib trial: Analysis of safety and clinical activity [abstract]. J Clin Oncol. 2016;34(15 Suppl):4009.) |
89 |
Avelumab 10 mg/kg every 2 weeks |
Metastatic Maintenance |
8.9 (2.2) |
57.3 |
3.0 |
- |
9.9 |
CheckMate-032 (2020. Janjigian YY, Ott PA, Calvo E, Kim JW, Ascierto PA, Sharma P. Nivolumab ± ipilimumab in pts with advanced (adv)/metastatic chemotherapy-refractory (CTx-R) gastric (G), esophageal (E), or gastroesophageal junction (GEJ) cancer: CheckMate 032 study [abstract]. J Clin Oncol. 2017;35:(Suppl 4s):4014.) Group 1 |
59 |
Nivolumab 3 mg/kg every 2 weeks |
Metastatic Previously treated (100%) |
12 (2) |
32 |
1.4 |
6.2 |
17 |
CheckMate-032 (2020. Janjigian YY, Ott PA, Calvo E, Kim JW, Ascierto PA, Sharma P. Nivolumab ± ipilimumab in pts with advanced (adv)/metastatic chemotherapy-refractory (CTx-R) gastric (G), esophageal (E), or gastroesophageal junction (GEJ) cancer: CheckMate 032 study [abstract]. J Clin Oncol. 2017;35:(Suppl 4s):4014.) Group 2 |
49 |
Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks |
Metastatic Previously treated (98%) |
22 (2) |
41 |
1.4 |
6.9 |
47 |
CheckMate-032 (2020. Janjigian YY, Ott PA, Calvo E, Kim JW, Ascierto PA, Sharma P. Nivolumab ± ipilimumab in pts with advanced (adv)/metastatic chemotherapy-refractory (CTx-R) gastric (G), esophageal (E), or gastroesophageal junction (GEJ) cancer: CheckMate 032 study [abstract]. J Clin Oncol. 2017;35:(Suppl 4s):4014.) Group 3 |
52 |
Nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks |
Metastatic Previously treated (100%) |
8 (0) |
37 |
1.6 |
4.8 |
27 |
ATTRACTION-2 (2121. Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, et al. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;390(10111):2461-71, http://dx.doi.org/10.1016/S0140-6736(17)31827-5. http://dx.doi.org/10.1016/S0140-6736(17)...
) |
493 |
Nivolumab 3 mg/kg every 2 weeks |
Metastatic 2+ lines of treatment |
11 (0) |
40.3 |
1.6 |
5.2 |
10 |
ATTRACTION-2 (2121. Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, et al. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;390(10111):2461-71, http://dx.doi.org/10.1016/S0140-6736(17)31827-5. http://dx.doi.org/10.1016/S0140-6736(17)...
) |
493 |
Placebo |
|
0 (0) |
25.0 |
1.4 |
4.1 |
4 |
KEYNOTE-061 (2525. Shitara YJ, Özgüroglu M, Bang YJ, Di Bartolomeo M, Mandalà M, Ryu MH, et al. Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial. Lancet. 2018;392(10142):123-33, http://dx.doi.org/10.1016/S0140-6736(18)31257-1. http://dx.doi.org/10.1016/S0140-6736(18)...
) |
592 |
Pembrolizumab 200 mg every 3 weeks |
|
16 (4)
|
- |
1.5 |
9.1 |
14 |
|
|
Paclitaxel (weekly) |
|
14 (3) |
- |
4.1 |
8.3 |
35 |
JAVELIN 300 (2424. Bang YJ, Ruiz EY, Van CutsemE, Lee KW, Wyrwics L, Schenker M, et al. Phase 3, randomised trial of avelumab versus physician’s choice of chemotherapy as third-line treatment for patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300. Ann Oncol. 2018, http://dx.doi.org/10.1093/annonc/mdy264. http://dx.doi.org/10.1093/annonc/mdy264...
) |
371 |
Avelumab 10 mg/kg every 2 weeks |
Metastatic |
2.2 (0.5) |
22.2 |
1.4 |
4.6 |
9.2 |
|
|
Chemoterapy
|
Third-line (86%) |
4.3 (0.5) |
44.1 |
2.7 |
5.0 |
31.6 |