Table 2.
Best objective response by the 2014 Lugano classification based on IRC evaluation of the full analysis set (FAS; n=85).
| IRC-evaluated | |
|---|---|
| ORR, n (%) (95% CI) | 76 (89.4) (80.8, 95.0) |
| DCR, n (%) (95% CI) | 82 (96.5) (90.0, 99.3) |
| CR, n (%) | 40 (47.1) |
| PR, n (%) | 36 (42.4) |
| SD, n (%) | 6 (7.1) |
| PD, n (%) | 3 (3.5) |
| Not evaluable, n (%) | 0 |
| TTR (month), median (range) | 1.8 (1.4, 6.9) |
| DoR (month)[a] | |
| Median (range) | NR (1.7, 24.5+) b |
| 95% CI | 13.0, NE |
| 6 | 89.4 (80.0, 94.6) |
| 9 | 83.8 (73.2, 90.5) |
| 12 | 74.9 (62.4, 83.8) |
| Still remaining in response, n (%) [a] | 56 (73.7) |
| PFS (month) a | |
| Median | NR (NE, NE) |
| 6 | 88.2 (79.2, 93.5) |
| 9 | 78.4 (67.9, 85.8) |
| 12 | 72.1 (60.5, 80.8) |
| OS (month) a | |
| Median | NR (NE, NE) |
| 12 | 100 (100, 100) |
| 18 | 100 (100, 100) |
CI, confidence interval; CR, complete response; DoR, duration of response; IRC: Independent Review Committee; NE, not evaluable; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; SD, stable disease; TT, time to tumor response. a Kaplan-Meier method; b some cases were censored.