Table 4.
Efficacy results in hepatocellular carcinoma in REFLECT
| Efficacy endpoint | Lenvatinib, n = 478 | Sorafenib, n = 476 |
|---|---|---|
| Overall survival | ||
| Number of deaths (%) | 351 (73) | 350 (74) |
| Median OS, (95% CI), mo | 13.6 (12.1–14.9) | 12.3 (10.4–13.9) |
| Hazard ratio (95% CI) a | 0.92 (0.79–1.06) | 0.92 (0.79–1.06) |
| Progression‐free survival by IRF per mRECIST for HCC | ||
| Number of events (%) | 311 (65) | 323 (68) |
| Median PFS (95% CI), mo | 7.3 (5.6–7.5) | 3.6 (3.6–3.7) |
| Hazard ratio (95% CI) a , b | 0.64 (0.55–0.75) | 0.64 (0.55–0.75) |
| Progression‐free survival by IRF per RECISTv1.1 | ||
| Number of events (%) | 307 (64) | 320 (67) |
| Median PFS in months (95% CI) | 7.3 (5.6–7.5) | 3.6 (3.6–3.9) |
| Hazard ratio (95% CI) a | 0.65 (0.56–0.77) | 0.65 (0.56–0.77) |
| Overall response rate by IRF per mRECIST for HCC, % (95% CI) | 41 (36–45) | 12 (10–16) |
| Overall response rate by IRF per RECIST v1.1, %, (95% CI) | 19 (15–22) | 7 (4–9) |
a
Stratified by region (Asia‐Pacific vs Western), macroscopic portal vein invasion or extrahepatic spread or both (yes, no), Eastern Cooperative Oncology Group performance status (0, 1), and body weight (<60 kg, ≥60 kg).
b
Nominal p values <.001
Abbreviations: CI, confidence interval; HCC, hepatocellular carcinoma; IRF, independent radiology facility; mRECIST, modified RECIST for HCC; OS, overall survival; PFS, progression‐free survival.