Table 3.
PFS and response rate per Independent assessment (RECIST V.1.1)
| Enadenotucirev IP monotherapy (n=10) | Enadenotucirev IP+paclitaxel (n=8) | Enadenotucirev IV+paclitaxel (n=20) | |
| PFS, % (95% CI) | |||
| Median | 1.7 (1.2 to 3.5) | 6.4 (1.3 to 6.4) | 6.2 (2.8 to 11.1) |
| 4 month PFS rate | 11.1 (0.6 to 38.8) | 66.7 (19.5 to 90.4) | 63.8 (36.1 to 82.1) |
| 6 month PFS rate | 0.0 (NE to NE) | 66.7 (19.5 to 90.4) | 54.7 (26.5 to 76.1) |
| Best overall response, n (%) | |||
| Complete response | 0 | 0 | 0 |
| Partial response | 0 | 0 | 2 (10) |
| Stable disease | 0 | 2 (25) | 7 (35) |
| Progressive disease | 7 (70) | 2 (25) | 5 (25) |
| Not evaluable | 3 (30) | 4 (50) | 6 (30) |
| Overall response rate, % | 0 | 0 | 10 |
| 95% CI | – | – | 1 to 32 |
| Clinical benefit rate, % | 0 | 25 | 45 |
| 95% CI | – | 3 to 65 | 23 to 69 |
IP, intraperitoneal; IV, intravenous; PFS, progression-free survival.