Table 5.
Phase 1b study (arm A, n = 104): PFS and OS [modified from 37]
| IRF RECIST v1.1 | IRF HCC mRECIST | INV RECIST v1.1 | |
|---|---|---|---|
| PFS | |||
| Events | 69 (66%) | 69 (66%) | 75 (72%) |
| PFS, months | 7.3 (5.4–9.9) | 7.3 (5.4–9.9) | 7.4 (5.6–10.7) |
| 6-month PFS rate | 54% | 55% | 56% |
| 12-month PFS rate | 35% | 35% | 38% |
| OS | |||
| Deaths | 47 (45%) | ||
| OS, months | 17.1 (13.8 − NE) | ||
| 6-month OS rate | 82% | ||
| 12-month OS rate | 63% | ||
Median duration of follow-up: 12.4 months. Figures are presented as median (95% CI) or n (%). IRF, independent review facility; HCC, hepatocellular carcinoma; INV, investigators; PFS, progression-free survival; OS, overall survival; NE, not estimable.