Table 1.
Patient baseline characteristics
| Characteristics | Dose-escalation cohort (n = 54) | Dose-expansion cohort (n = 99) | Total (n = 153) |
|---|---|---|---|
| Median age (range), years | 51.6 (28–69) | 50.2 (24–70) | NA |
| ≤60, n (%) | 45 (83.3) | 80 (80.8) | 125 (81.7) |
| >60, n (%) | 9 (16.7) | 19 (19.2) | 28 (18.3) |
| Sex, n (%) | |||
| Male | 21 (38.9) | 49 (49.5) | 70 (45.8) |
| Female | 33 (61.1) | 50 (50.5) | 83 (54.2) |
| Tumor histology, n (%) | |||
| Squamous cell carcinoma | 2 (3.7) | 2 (2.0) | 4 (2.6) |
| Adenocarcinoma | 49 (90.7) | 91 (91.9) | 140 (91.5) |
| Othera | 3 (5.6) | 6 (6.1) | 9 (5.9) |
| ECOG PS, n (%) | |||
| 0 | 20 (37.0) | 30 (30.3) | 50 (30.7) |
| 1 | 34 (63.0) | 69 (69.7) | 103 (67.3) |
| ALK rearrangement status | |||
| Positive | 46 (85.2)b | 91 (91.9)c | 137 (89.5) |
| Negative | 8 (14.8) | 5 (5.1) | 13 (8.5) |
| Untested | 0 (0) | 3(3.0) | 3 (2.0) |
| ROS1 rearrangement status | |||
| Positive | 10 (18.5)b | 9 (9.1)c | 19 (12.4) |
| Negative | 23 (42.6) | 38 (38.4) | 61 (39.9) |
| Untested | 21 (38.9) | 52 (52.5) | 73 (47.7) |
| CNS measurable or non-measurable metastasis | |||
| Yes | 22 (40.7) | 58 (58.6) | 81 (52.9) |
| No | 32 (59.3) | 41 (41.4) | 72 (47.1) |
| ≥1 line of prior anti-cancer therapy | 43 (79.6) | 83 (83.8) | 126 (82.3) |
| Prior ALK TKIs | |||
| ALK TKI naive | 28 (51.9) | 42 (42.4) | 70 (45.8) |
| Crizotinib only | 21 (38.9) | 50 (50.5) | 71 (46.4) |
| Other ALK TKI only | 1 (1.9) | 2 (2.0) | 3 (2.0) |
| Both crizotinibd and other second-generation ALK TKI | 4 (7.4) | 5 (5.1) | 9 (5.9) |
ECOG Eastern Cooperative Oncology Group, PS performance status, ALK anaplastic lymphoma kinase, ROS1 c-ros oncogene 1 receptor kinase, CNS central nervous system, TKI tyrosine kinase inhibitor, NA not available
aOthers include large cell carcinoma, adenosquamous carcinoma and other undefined pathological subtypes
bTwo patients with both ALK and ROS1 rearrangement positive status in dose-escalation phase
cOne patient with both ALK and ROS1 rearrangement positive status in dose-expansion phase
dOne of the four patients received crizotinib generics