Table 3:
Efficacy Results Based on Independent Review in the TRIDENT-1 Study
| Efficacy Parameters | ROS1 Inhibitor Naïve Patients (N=71) |
ROS1 Inhibitor Pretreated Patients (N=56) |
|---|---|---|
| Confirmed Overall Response Rate, % (95% CI) | 79% (68, 88) | 38% (25, 52) |
| Complete Response | 6% | 5% |
| Partial Response | 73% | 32% |
| Duration of Response (DOR)a | ||
| Median in Months (95% CI)b | 34.1 (25.6, NE) | 14.8 (7.6, NE) |
| Range (months) | 1.4+, 42.4+ | 3.6, 22.9+ |
| % DOR ≥12 monthsc | 70 | 48 |
Abbreviations: CI: confidence interval, NE: not evaluable, and “+” indicates ongoing response
a
DOR results are based on the updated data as of December 19, 2022.
b
Median DOR (95% CI) are based on Kaplan-Meier estimates.
c
DOR analysis is based on the observed DOR.
Source: U.S. Food and Drug Administration Repotrectinib Label (USPI).15