TABLE III.
Phase II and III trials of immunotherapy in the second- and third-line treatment of hepatocellular carcinoma
| Study name | Phase | Arms | Child–Pugh score | OS (months) | PFS (months) | ORR (%) | Discontinuation rate because of drug-related AEs (%) | Treatment-related AEs (%) | |
|---|---|---|---|---|---|---|---|---|---|
|
| |||||||||
| Any grade | Grade 3 or 4 | ||||||||
| CheckMate 040 | I/II | Single-arm nivolumab | |||||||
| ♦ Dose escalation phase | A–B7 | — | — | 15 | 2 | 83 | 25 | ||
| ♦ Dose expansion phase | A | 20 | 4 | NR | 19 | ||||
|
| |||||||||
| CheckMate 040 | I/II | Nivolumab–ipilimumab | A | — | — | 31 | 14 | NR | 37 |
|
| |||||||||
| KEYNOTE-240 | III | Pembrolizumab | A–B7 | 13.9 | 3 | 18 | 30 | 61 | 19 |
| vs. placebo | 10.6a | 2.8a | 4 | 16 | 48 | 7 | |||
|
| |||||||||
| Study 22 | II | Tremelimumab 300 mg + durvalumab | — | 18.7 | — | 24 | 10.8 | 82 | 35 |
| Tremelimumab 75 mg + durvalumab | 11.3 | 9.5 | 6.1 | 69 | 23 | ||||
| Single-agent durvalumab | 13.6 | 10.6 | 7.9 | 60 | 18 | ||||
| Single-agent tremelimumab | 15.1 | 7.2 | 13 | 84 | 43 | ||||
a
Not statistically significant.
OS = overall survival; PFS = progression free survival; ORR = objective response rate; AEs = adverse events; NR = not reported.