Table 2.
Efficacy outcomes in Chinese un-resectable hepatocellular carcinoma (uHCC) patients and LEAP-002 study receiving lenvatinib plus PD-1 inhibitors
| Parameter | Present study | LEAP-002 study | |
|---|---|---|---|
| Lenvatinib plus PD-1 inhibitors (N = 378) |
Lenvatinib plus pembrolizumab (N = 395) |
Lenvatinib plus placebo (N = 399) |
|
| ORR, % (95 CI) | 19.6 (15.6–23.6) | 26.1% | 17.5% |
| Best overall response | |||
| CR, no. (%) | 0 (0) | – | – |
| PR, no. (%) | 74 (19.6) | – | – |
| SD, no. (%) | 221 (58.5) | – | – |
| PD, no. (%) | 57 (15.1) | – | – |
| Unknown/not evaluable, no. (%) | 26 (6.9) | – | – |
| DCR, % (95 CI) | 78.0 (73.9–82.2) | 81.3% | 78.4% |
| DCB, % (95 CI) | 50.0 (45.0–55.0) | – | – |
| DOR, % (95 CI) | 10.8 (7.5–14.0) | 16.6 (range: 2.0 +–33.6 +) | 10.4 (range: 1.9–35.1 +) |
| Median PFS, months (95%CI) | 6.9 (6.0–7.9) | 8.2 (6.4–8.4) | 8.0 (6.3–8.2) |
| 6 months, % (95 CI) | 44.0 (38.9–49.2) | – | – |
| 12 months, % (95 CI) | 15.0 (11.3–18.6) | 34.1% | 29.3% |
| Median OS, months, months (95%CI) | 17.8 (14.0–21.6) | 21.2 (19.0–23.6) | 19.0 (17.2–21.7) |
| 6 months, % (95 CI) | 75.4 (71.1–79.7) | – | – |
| 12 months, % (95 CI) | 43.7 (38.7–48.7) | – | – |
| 18 months, % (95 CI) | 18.3 (14.4–22.1) | – | – |
| Median follow-up, month (IQR) | 10.4 (6.2–15.8) | 32.1 (range: 25.8–41.1) | |
CI confidence interval, CR complete response, DCR disease control rate, DCB durable clinical benefit, DOR duration of response, IQR interquartile range, ORR objective response rate, OS overall survival, PD progressive disease, PFS progression-free survival, PR partial response, SD stable disease