Table 1.
Phase III trials evaluating ICI across HCC stages.
| Trial (Ref) | No patients | mRFS (months) | HR RFS | ORR% | mDOR (months) | mPFS (months) | HR PFS | mOS (months) | HR OS | TRAE leading to discontinuation % (% discontinuing ICI alone) |
|---|---|---|---|---|---|---|---|---|---|---|
| Adjuvant | ||||||||||
| IMbrave 05079 | ||||||||||
| Atezolizumab/bevacizumab | 334 | NE | 0.72 | NE | NE | NE | NE | NE | NE | 9 |
| Surveillance |
334 |
NE |
||||||||
| Intermediate stage | ||||||||||
| EMERALD-189 | ||||||||||
| TACE + durvalumab + bevacizumab | 204 | 43.6 | NE | 15 | 0.77 | NE | NE | 8.4 | ||
| TACE + durvalumab | 207 | 41 | 10 | 0.94 | 4.3 | |||||
| TACE |
205 |
29.6 |
8.2 |
3.5 |
||||||
| Advanced disease | ||||||||||
| IMbrave1504 | ||||||||||
| Atezolizumab/bevacizumab | 336 | 30 | NE | 6.9 | 0.65 | 19.2 | 0.66 | 22 (10) | ||
| Sorafenib | 165 | 11 | NE | 4.3 | 13.4 | 12 | ||||
| ORIENT-3272 | ||||||||||
| Sintilimab/bevacizumab biosimilar | 380 | 21 | NE | 4.6 | 0.56 | NR | 0.57 | 14 | ||
| Sorafenib | 191 | 4 | 9.8 | 2.8 | 10.5 | 6 | ||||
| HIMALAYA69 | ||||||||||
| Tremelimumab/durvalumab | 393 | 21.1 | 22.3 | 5.4 | 0.9 | 16.4 | 0.78 | 14 | ||
| Durvalumab | 389 | 17 | 16.8 | 3.8 | 1.02 | 16.6 | 0.86 | 8 | ||
| Sorafenib | 389 | 5 | 18.4 | 5.6 | 13.7 | 17 | ||||
| COSMIC-31273 | ||||||||||
| Atezolizumab/cabozantanib | 432 | 11 | 12.4 | 6.8 | 0.63 | 15.4 | 0.9 | 14 (6) | ||
| Sorafenib | 217 | 4 | 8.4 | 4.2 | 15.5 | 8 | ||||
| LEAP-00274 | ||||||||||
| Pembrolizumab/lenvatinib | 395 | 26 | 16.6 | 8.2 | 0.87 | 21.2 | 0.84 | 18 (6) | ||
| Lenvatinib | 399 | 17 | 10.4 | 8 | 19 | 11(5) | ||||
| RATIONALE -30170 | ||||||||||
| Tislelizumab | 342 | 14.3 | 36.1 | 2.1 | 1.11 | 15.9 | 0.85 | 10.9 | ||
| Sorafenib | 332 | 5.4 | 11 | 3.4 | 14.1 | 18.5 | ||||
| CheckMate 45965 | ||||||||||
| Nivolumab | 371 | 15 | 23.3 | 3.7 | 0.93 | 16.4 | 0.85 | 7 | ||
| Sorafenib | 372 | 7 | 23.4 | 3.8 | 14.7 | 11 | ||||
| CARES-31075 | ||||||||||
| Camrelizumab/rivoceranib | 272 | 25 | 14.8 | 5.6 | 0.52 | 22.1 | 0.62 | 24 (4) | ||
| Sorafenib | 271 | 6 | 9.2 | 3.7 | 15.2 | 4 | ||||
(m)DOR, (median) duration of response; HCC, hepatocellular carcinoma; HR, hazard ratio; ICI, immune checkpoint inhibitor; NE, not evaluable; NR, not reached; ORR, objective response rate; (m)OS, (median) overall survival; (m)PFS, (median) progression-free survival; (m)RFS, (median) recurrence-free survival; TACE, transarterial chemoembolisation; TRAE, treatment-related adverse event.