Table 1.
Summary of outcomes of key phase 3 first-line trials in advanced HCC
| Trial | Comparator | Median OS (months) | PFS (months) | ORR (%) |
|---|---|---|---|---|
| REFLECT3 | Lenvatinib vs. sorafenib (control) | 13.6 vs. 12.3; HR, 0.92; 95% CI, 0.79-1.06* | 7.4 vs. 3.7; HR, 0.66; 95% CI, 0.57-0.77 | 18.8 vs. 6.5 |
| SHARP2 | Sorafenib vs. placebo (control) | 10.7 vs. 7.9; HR, 0.69; 95% CI, 0.55-0.87 | 5.5 vs. 2.8; HR, 0.58; 95% CI, 0.45-0.74 | 18.8 vs. 6.5 |
| IMBrave-1506,16 | Atezolizumab plus Bevacizumab vs. sorafenib (control) | 19.2 vs. 13.4; HR, 0.66; 95% CI, 0.52-0.85 | 6.8 vs. 4.3; HR, 0.59; 95% CI, 0.47-0.76 | 30 vs. 11 |
| HIMALAYA8 | Durvalumab plus tremelimumab vs. sorafenib (control) | 16.4 vs. 13.8; HR, 0.78; 95% CI, 0.65-0.92 | 3.8 vs. 4.1; HR, 0.90; 95% CI, 0.77-1.05 | 20.1 vs. 5.1 |
HCC, hepatocellular carcinoma; OS, overall survival; PFS, progression-free survival; ORR, overall response rate; HR, hazard ratio; CI, confidence interval.
Non-inferiority criteria met.