Table 2. Phase III trials.
| Sorafenib vs. placebo Decision | Lenvatinib vs. placebo Select | |
|---|---|---|
| Patients (n) | 207 vs. 210 | 261 vs. 131 |
| CR | 0% vs. 0% | 1.5% (n = 4) vs. 0% |
| PR | 12.2% vs. 0.5% | 63.2% vs. 1.5% |
| SD > 23 weeks | 41.8% vs. 33.2% | 15.3% vs. 29.8% |
| PFS months (median) | 10.8 vs. 5.8 (HR 0.59 p < 0.0001) | 18.3 vs. 3.6 (HR 0.21 p < 0.001) |
| Grade 3-4 AEs | 37.2% vs. 26.3% | 75.9% vs. 9.9% |
| OS | NS* | NS* |
CR: complete response; PR: partial response; SD: stable disease; PFS: progression free survival; HR: hazard ratio; AEs: adverse events; OS: overall survival; NS: not statistically significant.
* Probably related to the crossover that occurs in most patients who progressed from the placebo treatment to the therapy treatment.