Table 4.
Non-TKI | Trial | Comparison | Setting | Enrolled Patients (%) | OS | PFS/TTRP * | ORR/DCR ** | Grade 3–4 AEs |
---|---|---|---|---|---|---|---|---|
Galunisertib (LY2157299) | Phase II [139] |
/ | Second-line | - Child–Pugh Stage A (100%) - Westerns (85%) - HBV (20%), HCV (24%) - Macrovascular invasion (26%) |
7.3 months for patients with high baseline AFP levels 16.8 months for patients with lower baseline AFP levels |
2.7 months for patients with high baseline AFP levels * 4.2 months for patients with lower baseline AFP levels * |
2% | 43.6% |
Galunisertib (LY2157299) + Sorafenib (Nexavar) |
Phase II [140] |
/ | First-line | - Child–Pugh Stage A (100%) - Westerns (46%) - HBV (18%), HCV (34%). - Extrahepatic disease (80%) - Macrovascular invasion (34%) |
18.8 months | 4.1 months * | 4.5% 51% ** |
59.5% |
TRC105 + Sorafenib (Nexavar) |
Phase I [142] |
/ | First-line | - Child–Pugh Stage A (90%) - HBV (12%), HCV (60%). - Extrahepatic disease (68%) |
15.5 months | 3.8 months | 25% | 52% |
Abbreviations: tyrosine kinase inhibitor (TKI); Progression free-Survival (PFS); Overall Survival (OS); Objective Response Rate (ORR); Time to Radiological Progression (TTRP) *; Disease Control Rate (DCR) **.