Table 4.
Key clinical trials involving immunotherapy agents in first line setting in hepatocellular carcinoma.
| Study (n) | Regimen or Drug(s) Evaluated | Molecular Targets | ORR (%) | mPFS (Months) |
mOS (Months) |
|---|---|---|---|---|---|
| IMbrave 150 (n = 501) | Atezolizumab 1200 mg + bevacizumab 15 mg/kg (A + B) compared to sorafenib (S) | PD-L1, VEGF | A + B: 30 S: 11.3 |
A + B: 6.9 S: 4.3 |
A + B: 19.2 S: 13.4 |
| CheckMate 459 (n = 743) | Nivolumab 240 mg/ 2 weeks (N) compared to sorafenib 400 mg twice daily (S) | PD-1 | N: 15 S: 7 |
Nivolumab: 3.7 Sorafenib: 3.8 |
Nivolumab: 16.4 Sorafenib: 14.7 |
| KEYNOTE-224 (n = 104) |
Pembrolizumab | PD-1 | 16 | 4 | 17 |
| KEYNOTE-524 (n = 104) |
Pembrolizumab and lenvatinib | PD-1, multiple kinases (VEGF, FGF, PDGFRα, RET, KIT) | 46 | 9.3 | 22 |
| COSMIC-312 (n = 837) |
Atezolizumab 1200 mg + cabozantinib 40 mg or cabozantinib 60 mg compared to sorafenib | PD-L1, multiple kinases (c-Met VEGFR2, AXL, and RET) | − | A + C: 6.8 S: 4.2 |
− |
| RESCUE (n = 70, first-line setting) |
Camrelizumab 3 mg/kg (max: 200 mg) every 2 weeks + apatinib 250 mg | humanized, IgG4-κ PD-1 mAb, VEGFR-2 | 34.3 | 5.7 | - |
ORR: Overall Response Rate Per HCC specific modified RECIST criteria; mPFS: median Progression Free Survival of the cohort receiving active agent; mOS: median Overall Survival of the cohort receiving active agent; VEGFR: Vascular endothelial growth factor receptor; RAF: Rapidly accelerated fibrosarcoma; EGFR: Epidermal growth factor receptor; FGFR: Fibroblast growth factor receptor; PDGFR: Platelet derived growth factor receptor; PD-1/PD-L1: programmed death-ligand 1.