Table 3.
Efficacy by treatment phase (safety population)
| ESCAL | EXP | RP2D 300 mg ESCAL+EXP (n = 40) |
Overall ESCAL+EXP (N = 59) |
|
|---|---|---|---|---|
| Overall (n = 33) |
RP2D 300 mg (n = 26) |
|||
| ORR, n (%) [95% CI] |
32 (97.0) [84.2-99.9] |
24 (92.3) [74.9-99.1] |
38 (95.0) [83.1-99.4] |
56 (94.9) [85.9-98.9] |
| CR | 30 (90.9) | 22 (84.6) | 35 (87.5) | 52 (88.1) |
| PR | 2 (6.1) | 2 (7.7) | 3 (7.5) | 4 (6.8) |
| SD | 1 (3.0) | 1 (3.8) | 1 (2.5) | 2 (3.4) |
| Median time to response, months* | 2.2 | 2.1 | 2.1 | 2.1 |
| PFS rate at 1 y, % | 96.8 | 69.2 | 77.5 | 84.1 |
| PFS rate at 2 y, % | 89.9 | 65.2 | 72.4 | 78.6 |
ESCAL, dose-escalation phase; EXP, expansion phase; ORR, overall response rate; PFS, progression-free survival; SD, stable disease.
*
Overall responders only.