Table 1.
Key findings of landmark clinical trials in frontline treatment of advanced HCC.
| Trial n ame | Treatment arms | Primary endpoint | Patient number | ORR (%) | DCR (%) | PFS (months) | OS (months) | HR | Reference |
|---|---|---|---|---|---|---|---|---|---|
| SHARP | Sorafenib versus placebo | OS | 602 | 2 versus 1 | 43 versus 32 | 5.5 versus 2.8 | 10.7 versus 7.9 | 0.69 | Llovet et al. 5 |
| REFLECT | Lenvatinib versus sorafenib | OS | 954 | 24.1 versus 9.2 | 75.5 versus 60.5 | 7.4 versus 3.7 | 13.6 versus 12.3 | 0.92 | Bruix et al. 6 |
| IMbrave150 | Atezolizumab + bevacizumab versus sorafenib | OS, PFS | 501 | 27.3 versus 11.9 | 73.6 versus 55.3 | 6.8 versus 4.3 | 19.2 versus 13.4 | 0.66 | Finn et al. 10 |
| HIMALAYA | Tremelimumab + Durvalumab versus Sorafenib vs durvalumab | OS for tremelimumab + durvalumab vs sorafenib | 1324 | 20.1 versus 5.1 vs 17.0 | 60.1 vs 60.7 versus 54.8 | 3.78 versus 4.07 versus 3.65 | 16.4 versus 13.8 versus 16.6 | 0.78 | Abou-Alfa et al. 42 |
| COSMIC 312 | Cabozantinib and atezolizumab versus sorafenib versus cabozantinib | OS, PFS | 837 | 11 versus 3.7 versus 6.4 | 78 versus 84 versus 65 | 6.8 versus 4.2 versus 5.8 | 15.4 versus 15.5 vs NA | 0.90 | Kelley et al. 49 |
DCR, disease control rare; HCC, hepatocellular carcinoma; HR, hazard ratio; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; REFLECT, A phase 3, multinational, randomized, non-inferiority trial; SHARP, Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol.