Table 1.
Efficacy and Survival Outcomes of Anti-PD-1 Agents in Pivotal Clinical Trials
| Outcome | CheckMate 040 [28] Nivolumab | KEYNOTE-240 [35] Pembrolizumab | CheckMate 040 [33] Nivolumab Plus Ipilimumaba |
|---|---|---|---|
| Phase of the trial | Phase I/II | Phase III | Phase I/II |
| Population | Sorafenib-pretreated patients | Sorafenib-pretreated patients | Sorafenib-pretreated patients |
| Confirmed ORR per RECIST 1.1, % | 20 | 18.3 | 32 |
| 95% CI | (15–26) | (14–23.4) | (20–47) |
| Complete response, n (%) | 3 (1) | 6 (2.2) | 4 (8) |
| Partial response, n (%) | 39 (18) | 45 (16.2) | 12 (24) |
| Stable disease, n (%) | 96 (45) | 122 (43.9) | 9 (18) |
| Overall survival (months) | |||
| Median | NR | 13.9 | 22.8 |
| 95% CI | - | (11.6–16) | (9.4-NE) |
| Progression-free survival (months) | |||
| Median | 4.0 | 3.0 | Not reported |
| 95% CI | (2.9–5.4) | (2.8–4.1) |
Notes: aData from the arm A of the trial; references are reported in square brackets.
Abbreviations: ORR, objective response rate; RECIST 1.1, response evaluation criteria in solid tumors version 1.1; 95% CI, 95% confidence interval; n, number of patients; NR, not reached; NE, not estimable.