Table 1.
Results of Phase III trials of ICIs in patients with GC
| Trial | Line | Primary end point | PD-L1 status | Arm | N | RR (%) | PFS (months) | OS (months) | Grade ≥3 TRAEs (%) |
|---|---|---|---|---|---|---|---|---|---|
| ATTRACTION-02 | Third and above | OS | Unselected | Nivolumab Placebo |
330 163 |
11.2 0 |
1.6 1.5 HR =0.60 (0.49–0.75) P<0.0001 |
7.5 5.1 HR =0.63 (0.49–0.75) P<0.0001 |
10 4 |
| KEYNOTE-061 | Second | OS PFS | Positive | Nivolumab PTX |
196 199 |
16 14 |
1.5 4.1 HR =1.27 (1.03–1.57) |
9.1 8.3 HR =0.82 (0.66–1.03) P=0.0421 |
14 35 |
| JAVELIN Gastric 300 | Third⪳ | OS | Unselected | Nivolumab Physician’s choice (PTX or IRI) |
272 133 |
2.2 4.3 |
1.4 2.7 HR =1.73 (1.4–2.2) P>0.99 |
4.6 5.0 HR =1.1 (0.9–1.4) P=0.81 |
9.2 31.6 |
Abbreviations: GC, gastric cancer; ICI, immune checkpoint inhibitor; IRI, irinotecan; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; PTX, paclitaxel; RR, response ratio; TRAEs, treatment-related adverse events.