Table 2.
Summary of main outcomes among systemic therapies (immunotherapy) approved for advanced HCC.
| Study | Year Published | Phase | Number of Patients | Line of Tx | Tx | Control | CR (%) | ORR (%) | mPFS (Months) | mOS (Months) | HR x (95% CI) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IMbrave 150 [23,24] | 2018 | III | 501 | First | Atezolizumab + Bevacizumab | Sorafenib | 8 vs. 1 | 30 vs. 11 | All: 6.8 vs. 4.3 HBV: 6.7 vs. 2.8 HCV: 8.8 vs. 5.8 Non-viral 7.1 vs. 5.6 |
All: 19.2 vs. 13.4 HBV: 19.0 vs. 12.4 HCV: 24.6 vs. 12.6 Non-viral: 17.0 vs. 18.0 |
All: 0.66 (0.52–0.85) HBV: 0.58 (0.40–0.83) HCV: 0.43 (0.25–0.73) Non-viral: (0.68–1.63) |
| CheckMate 459 [19] | 2021 | III | 743 | First | Nivolumab | Sorafenib | 4 vs. 1 | 16 vs. 7 | 3.8 vs. 3.9 | 16.4 vs. 14.7 * | 0.85 (0.72–1.02) |
| KEYNOTE-240 [20] | 2019 | III | 413 | Second | Pembrolizumab | BSC | 2 vs. 0 | 18 vs. 4 | 3.0 vs. 2.8 | 13.6 vs. 10.6 * | 0.78 (0.61–1.00) |
| KEYNOTE-240 (Asian cohort) [49] | 2019 | III | 157 | Second | Pembrolizumab | BSC | - | 21 vs. 2 | 2.8 vs. 1.4 | 13.8 vs. 8.3 | 0.55 (0.37–0.80) |
| CheckMate 040 (cohort 4) + [21] | 2020 | I/II | 50 | Second | Nivolumab + Ipilimumab | - | 8 | 32 | - | 22.2 | - |
| CheckMate 040 (dose expansion cohort) [17] | 2017 | I/II | 214 | Mixed | Nivolumab | - | 1 | 20 | 4.0 | NR | - |
| KEYNOTE-224 [18] | 2018 | II | 104 | Second | Pembrolizumab | - | 1 | 17 | 4.9 | 12.9 | - |
| Study 22 ++ [22] | 2021 | I/II | 75 | Second | Tremelimumab + Durvalumab | - | 1 | 24 | 2.2 | 18.7 | - |
| HIMALAYA [51] | 2022 | III | 393 | First | Tremelimumab + Durvalumab | Sorafenib | 3 vs. 0 | 20 vs. 5 | 3.8 vs. 4.1 | 16.4 vs. 13.8 | 0.78 (0.65–0.92) |
BSC: Best supportive care; CI: Confidence interval; HR: Hazard ratio; mOS: Median overall survival; mPFS: Median progression-free survival; NR: Not reached; ORR: Objective response rate; Tx: Treatment; * did not reach statistical significance; + results from the Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg Q4wk arm; ++ results from the T300+D arm; x HR for mOS.