Table 2.
Lorlatinib therapy clinical outcome
| Characteristics | N = 80 |
|---|---|
| Median follow-up (IQR), months | 22.2 (13.6-31.3) |
| Median PFS (95% CI), months | 7.1 (5.0-9.9) |
| Median OS (95% CI), months | 19.6 (12.3-27.5) |
| Median OS from advanced or metastatic NSCLC diagnosis (95% CI), months | 51.9 (41.8-74.5) |
| Best response overall response to lorlatinib, n (%) | |
| Number of patients with available data | 76 (95) |
| Complete response | 0 (0) |
| Partial response | 34 (45) |
| Objective response | 34 (45) |
| Stable disease | 28 (37) |
| Progression | 12 (16) |
| Not evaluable | 2 (3) |
| Median duration of response (95% CI), months | 6.9 (5.1-20.6) |
| CNS objective responsea (available data; %) | 33 (/46; 72) |
| CNS objective response in patients with prior brain radiotherapya (available data; %) | 18 (/24; 75) |
| CNS objective response in patients without prior brain radiotherapya (available data; %) | 15 (/22; 68) |
| Median duration of CNS response (95% CI), months | 16.7 (5.1-20.6) |
| Median duration of CNS response in patients with prior brain radiotherapy (95% CI), months | 9.0 (2.8-NR) |
| Median duration of CNS response in patients without prior brain radiotherapy (95% CI), months | 20.6 (1.9-22.7) |
| Median lorlatinib duration (95% CI), months | 7.4 (6.5-13.1) |
| Median lorlatinib duration beyond progression (95% CI), months | 0.9 (0.4-2.0) |
| Treatment discontinuation, n (%) | 53 (66) |
| Cause of treatment discontinuation, n (%) | |
| Disease progression | 37 (46) |
| Toxicity | 10 (13) |
| Death | 4 (5) |
| Investigator’s decision | 1 (1) |
| Patient’s decision | 1 (1) |
| Intercurrent disease | 1 (1) |
| PFS according to the number of previous ROS1 TKI lines | |
| 1 ROS1 TKI (95% CI), months(n=20, %) | 7.6 (6.2-12.9) |
| 2 ROS1 TKI (95% CI), months | 2.8 (1.6-9.0) |
| ≥3 ROS1 TKI (95% CI) months | 6.9 (0.5-NR) |
| OS according to the number of previous ROS1 TKI lines | |
| 1 ROS1 TKI (95% CI), months(n=20, %) | 20.7 (12.3-27.5) |
| 2 ROS1 TKI (95% CI), months | 19.1 (2.9-NR) |
| ≥3 ROS1 TKI (95% CI), months | 10 (1.0-14.1) |
| Objective response according to the number of previous ROS1 TKI lines | |
| 1 ROS1 TKI (n = 60) n (%)(n=20, %) | 29 (48) |
| 2 ROS1 TKI (n = 12) n (%) | 4 (33) |
| ≥3 ROS1 TKI (n = 4) n (%) | 1 (25) |
CI, confidence interval; CNS, central nervous system; IQR, interquartile range; NR, not reached; NSCLC, non-small-cell lung cancer; OS, overall survival; PFS, progression-free survival; TKI, tyrosine kinase inhibitor.
a
Defined as the rate of intracranial tumor response according to RECIST v1.1.