Table 1.
Efficacy results of the REFLECT Phase III trial
| Outcome based on investigator assessment per mRECIST | Lenvatinib (n=478) | Sorafenib (n=476) | HR (95% CI) | P-value |
|---|---|---|---|---|
| Overall response rate | 115 (24%) | 44 (9.2%) | OR 3.13 (2.15–4.56) | <0.0001 |
| Response | ||||
| Complete | 6 (1%) | 2 (<1%) | – | – |
| Partial | 109 (23%) | 42 (9%) | – | – |
| Stable disease | 246 (51%) | 244 (51%) | – | – |
| Disease control rate | 361 (75.5%) | 288 (60.5%) | – | – |
| Overall survival (months) | ||||
| Median | 13.6 | 12.3 | 0.92 (0.79–1.06) | – |
| 95% CI | 12.1–14.9 | 10.4–13.9 | ||
| Progression-free survival (months) | ||||
| Median | 7.4 | 3.7 | 0.66 (0.57–0.77) | <0.0001 |
| 95% CI | 6.9–8.8 | 3.6–4.6 | ||
| Time to progression (months) | ||||
| Median | 8.9 | 3.7 | 0.63 (0.53–0.73) | <0.0001 |
| 95% CI | (7.4–9.2) | (3.6–5.4) | ||
| Outcome based on independent imaging review per mRECIST | Lenvatinib (n=478) | Sorafenib (n=476) | HR (95% CI) | P-value |
| Overall response rate | 194 (40.6%) | 59 (12.4%) | OR 5.01 (3.59–7.01) | <0.0001 |
| Response | ||||
| Complete | 10 (2%) | 4 (1%) | – | – |
| Partial | 184 (38%) | 55 (12%) | – | – |
| Stable disease | 159 (33%) | 219 (46%) | – | – |
| Disease control rate | 353 (73.8%) | 278 (58.4%) | – | – |
| Progression-free survival (months) | ||||
| Median | 7.3 | 3.6 | 0.64 (0.55–0.75) | <0.0001 |
| 95% CI | 5.6–7.5 | 3.6–3.7 | ||
| Time to progression (months) | ||||
| Median | 7.4 | 3.7 | 0.60 (0.51–0.71) | <0.0001 |
| 95% CI | (7.2–9.1) | (3.6–3.9) | ||
| Outcome based on independent imaging review per RECIST 1.1 | Lenvatinib (n=478) | Sorafenib (n=476) | HR (95% CI) | P-value |
| Overall response rate | 90 (18.8%) | 31 (6.5%) | OR 3.34 (2.17–5.14) | <0.0001 |
| Response | ||||
| Complete | 2 (<1%) | 1 (<1%) | – | – |
| Partial | 88 (18%) | 30 (6%) | – | – |
| Stable disease | 258 (54%) | 250 (53%) | – | – |
| Disease control rate | 348 (72.8%) | 281 (59%) | – | – |
| Progression-free survival (months) | ||||
| Median | 7.3 | 3.6 | 0.65 (0.56–0.77) | <0.0001 |
| 95% CI | 5.6–7.5 | 3.6–3.9 | ||
| Time to progression (months) | ||||
| Median | 7.4 | 3.7 | 0.61 (0.51–0.72) | <0.0001 |
| 95% CI | (7.3–9.1) | (3.6–5.4) |
Abbreviations: mRECIST, modified Response Evaluation Criteria in Solid Tumors; RECIST, Response Evaluation Criteria in Solid Tumors.