Summary of investigator-assessed efficacy
| Efficacy variable . | n = 86 . |
|---|---|
| ORR (CR + PR), % (95% CI)* | 83.7 (74.2-90.8) |
| Best response, n (%) | |
| CR | 67 (77.9) |
| PR | 5 (5.8) |
| SD | 1 (1.2) |
| PD | 8 (9.3) |
| Discontinued before first assessment | 5 (5.8) |
| Time to response (mo) | |
| Median (range) | 2.7 (2.5-3.0) |
| Time to CR (mo) | |
| Median (range) | 2.8 (2.5-16.7) |
| Response duration (mo) | |
| Median† (range) | NE (2.3-36.2+) |
| 95% CI | (24.9-NE) |
| Event-free rates‡ at 30 mo (%) | 57.3 |
| 95% CI | (44.9-67.9) |
| Efficacy variable . | n = 86 . |
|---|---|
| ORR (CR + PR), % (95% CI)* | 83.7 (74.2-90.8) |
| Best response, n (%) | |
| CR | 67 (77.9) |
| PR | 5 (5.8) |
| SD | 1 (1.2) |
| PD | 8 (9.3) |
| Discontinued before first assessment | 5 (5.8) |
| Time to response (mo) | |
| Median (range) | 2.7 (2.5-3.0) |
| Time to CR (mo) | |
| Median (range) | 2.8 (2.5-16.7) |
| Response duration (mo) | |
| Median† (range) | NE (2.3-36.2+) |
| 95% CI | (24.9-NE) |
| Event-free rates‡ at 30 mo (%) | 57.3 |
| 95% CI | (44.9-67.9) |
NE, not estimable; SD, stable disease.
ORR was calculated as a point estimate with 2-sided Clopper-Pearson 95% CIs.
Medians were estimated by Kaplan-Meier methodology with 95% CIs estimated using the Brookmeyer and Crowley method.
Event-free rates were estimated by Kaplan-Meier methodology, with 95% CIs estimated using Greenwood’s formula.