Table 2.
Independent review committee-assessed efficacy outcomes
| Efficacy variable | N = 70 |
|---|---|
| Objective response, n (%) | |
| Complete | 44 (62.9) |
| Partial | 17 (24.3) |
| No responsea | 9 (12.8) |
| Overall (%) | 87.1 |
| 95% CI for overall response rate | (77.0, 93.9) |
| P-valueb | <0.0001 |
| Time to responsec, weeks | |
| Median (range) | 12.0 (8.9–42.1) |
| DORc, months | |
| Mediand (range) | NE (0.0+ to 10.3+) |
| 95% CI | (NE, NE) |
| Event-free ratesc at 6 months (%) | 84.1 |
| 95% CI | (70.3, 91.8) |
| Progression-free survival, months | |
| Mediand (range) | NE (2.6–13.1+) |
| 95% CI | (NE, NE) |
| Event-free ratesc at 9 months (%) | 74.5 |
| 95% CI | (70.5, 89.4) |
NE denotes not estimable. + denotes censored observations
aOne patient who died from complications of progressive disease before any postbaseline tumor assessments is included in this category
bOne-sided p-value was based on exact test comparison of tislelizumab ORR versus reference rate (H0) of 0.35
cEvent-free rates were estimated by Kaplan–Meier methodology with 95% confidence intervals estimated using Greenwood’s formula
dMedians were estimated by Kaplan–Meier methodology with 95% confidence intervals estimated using the Brookmeyer and Crowley method