Table 3.
Summary of efficacy by dose and ALK and ROS1 rearrangement status in the dose-expansion phase
| 120 mg | 180 mg | Total | |
|---|---|---|---|
| All patients (n) | 50 | 49 | 99 |
| ORR (95% CI) | 50.0% (35.5%, 64.5%) | 63.3% (48.3%, 76.6%) | 56.6% (46.2%, 66.5%) |
| DCR (95% CI) | 82.0% (68.6%, 91.4%) | 85.7% (72.8%, 94.1%) | 83.8% (75.1%, 90.5%) |
| DOR (mo) | |||
| Median (95% CI) | NR (5.52, NR) | NR (5.49, NR) | NR (5.65, NR) |
| TTP (mo) | |||
| Median (95% CI) | NR (6.87, NR) | NR (NR, NR) | NR (6.93, NR) |
| PFS (mo) | |||
| Number of events (%) | 15 (30.0%) | 10 (20.4%) | 25 (25.2%) |
| Median (95% CI) | NR (6.83, NR) | NR (NR, NR) | NR (6.93, NR) |
| ALK-positive patients (n) | 47 | 44 | 91 |
| ORR (95% CI) | 53.2% (38.1%, 67.9%) | 63.6% (47.8%, 77.6%) | 58.2% (47.4%, 68.5%) |
| DCR (95% CI) | 83.0% (69.2%, 92.4%) | 88.6% (75.4%, 96.2%) | 85.7% (76.8%, 92.2%) |
| DOR (mo) | |||
| Median (95% CI) | NR (5.52, NR) | NR (5.49, NR) | NR (5.65, NR) |
| TTP (mo) | |||
| Median (95% CI) | NR (6.87, NR) | NR (NR, NR) | NR (6.93, NR) |
| PFS (mo) | |||
| Number of events (%) | 12 (25.5%) | 8 (18.2%) | 20 (22.0%) |
| Median (95% CI) | NR (6.87, NR) | NR (NR, NR) | NR (6.93, NR) |
| ROS1-positive patients (n) | 3 | 6 | 9 |
| ORR (95% CI) | 0 (0%, 70.8%) | 66.7% (22.3%, 95.7%) | 44.4% (13.7%, 78.8%) |
| DCR (95% CI) | 66.7% (9.4%, 99.2%) | 66.7% (22.3%, 95.7%) | 66.7% (29.9%, 92.5%) |
| DOR (mo) | |||
| Median (95% CI) | NR (NR, NR) | NR (NR, NR) | NR (NR, NR) |
| TTP (mo) | 3 (100%) | 2 (33.3%) | 5 (55.6%) |
| Median (95% CI) | 2.76 (1.35, 2.76) | NR (1.35, NR) | 2.76 (1.35, NR) |
| PFS (mo) | |||
| Number of events (%) | 3 (100%) | 2 (33.3%) | 5 (55.6%) |
| Median (95% CI) | 2.76 (1.35, 2.76) | NR (1.35, NR) | 2.76 (1.35, NR) |
ORR objective response rate, CI confidence interval, DCR disease control rate, DOR duration of response, TTP time to progression, PFS progression-free survival, NR not reached