Table 3.
TKI | Trial | Comparison | Setting | Enrolled Patients (%) | OS | PFS | ORR/DCR * | Grade 3–4 AEs |
---|---|---|---|---|---|---|---|---|
Donafenib (Zepsun) |
Phase II–III [129] |
Sorafenib | First-line | - Child–Pugh stage A (97%) - HBV (90%), HCV (2%). - Extrahepatic disease and/or Macrovascular invasion (70%) |
12.1 vs. 10.3 months HR 0.831; p = 0.0245 |
3.7 vs. 3.6 months; p = 0.0570 | 4.6% vs. 2.7%, p = 0.02448 30.8% vs. 28.7%; p = 0.5532 * |
38% vs. 50%; p = 0.0018 |
Nindetanib (BIBF 1120) |
Phase II [130] |
Sorafenib | First-line | - Child–Pugh Stage A (99%) - Orientals (100%) - HBV (63%), HCV (14%). - Extrahepatic disease and/or Macrovascular invasion (85%) |
11.9 vs. 11.4 months; HR 0.88 | 5.5 vs. 3.8 months; HR 1.05 | 68% vs. 90% |
Abbreviations: Tyrosine kinase inhibitor (TKI); Progression free-Survival (PFS); Overall Survival (OS); Objective Response Rate (ORR); Disease Control Rate (DCR) *.