Table 3.
Summary of efficacy measures in the efficacy-evaluable population (N=20).
| Outcomes | RECIST Version 1.1 | Modified RECIST |
|---|---|---|
| Best response^, n | ||
| CR | 1 | 2 |
| PR | 9 (3 unconfirmed) | 12 (3 unconfirmed) |
| SD | 9 | 5 |
| PD | 1 | 1 |
| Objective response rate#, n (%) | 7 (35.0) | 11 (55.0) |
| 95% CI | 15.4 to 59.2 | 31.5 to 76.9 |
| Objective response rate*, n (%) | 10 (50.0) | 14 (70.0) |
| 95% CI | 27.2 to 72.8 | 45.7 to 88.1 |
| Disease control rate*, n (%) | 19 (95.0) | 19 (95.0) |
| 95% CI | 73.1 to 99.9 | 73.1 to 99.9 |
| Duration of response*, median, months | 10.3 | 13.1 |
| 95% CI | 1.7 to NR | 1.7 to NR |
| Time to response*, median, months | 1.6 | 1.6 |
| 95% CI | 1.4 to 4.4 | 1.4 to 2.7 |
| PFS, median, months | 12.2 | 12.2 |
| 95% CI | 3.8 to NR | 3.8 to NR |
| 6-month PFS rate, % | 68.4 | 68.4 |
| 95% CI | 50.4 to 92.9 | 50.4 to 92.9 |
| 12-month PFS rate, % | 50.2 | 50.2 |
| 95% CI | 31.4 to 80.1 | 31.4 to 80.1 |
| OS, median, months | NR | NR |
| 95% CI | 16.3 to NR | 16.3 to NR |
| 18-month OS rate, % | 77.9 | 77.9 |
| 95% CI | 54.6 to 100 | 54.6 to 100 |
^Best response was evaluated by independent radiologic review per RECIST Version 1.1 and modified RECIST; #Including confirmed responses only; *Including both confirmed and unconfirmed responses.
CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; PFS, progression-free survival; OS, overall survival; NR, not reached.