Table 1.
Baseline characteristics (safety population).
| Characteristic | ACY-241 180 mg (n = 4) |
ACY-241 360 mg (n = 5) |
ACY-241 480 mg (n = 8) |
Total (N = 17) |
|---|---|---|---|---|
| Age, median (range), years | 66 (42-74) | 72 (53-81) | 65 (53-77) | 66 (42-81) |
| < 65 years, n (%) | 2 (50) | 1 (20) | 3 (38) | 6 (35) |
| ≥ 65 years, n (%) | 2 (50) | 4 (80) | 5 (63) | 11 (65) |
| Male, n (%) | 3 (75) | 3 (60) | 3 (38) | 9 (53) |
| ECOG PS, n (%) | ||||
| 0 | 2 (50) | 0 | 2 (25) | 4 (24) |
| 1 | 2 (50) | 5 (100) | 6 (75) | 13 (76) |
| Histology, n (%) | ||||
| Adenocarcinoma | 4 (100) | 3 (60) | 8 (100) | 15 (88) |
| Squamous cell | 0 | 2 (40) | 0 | 2 (12) |
| Smoking status, n (%) | ||||
| Current/former smoker | 3 (75) | 4 (80) | 6 (75) | 13 (76) |
| Never smoked | 1 (25) | 1 (20) | 2 (25) | 4 (24) |
| PD-L1 status, n (%) | ||||
| ≥ 1% a | 1 (50) | 3 (60) | 7 (88) | 11 (73) |
| Negative a | 1 (50) | 2 (40) | 1 (13) | 4 (27) |
| Unknown | 2 | 0 | 0 | 2 |
| Mutational status, n (%) | ||||
| Known | 4 (100) | 5 (100) | 6 (75) | 15 (88) |
| KRAS b | 0 | 3 (60) | 4 (67) | 7 (47) |
| EGFR b | 0 | 0 | 1 (17) | 1 (7) |
| Other b,c | 4 (100) | 2 (40) | 1 (17) | 7 (47) |
| Missing | 0 | 0 | 2 | 2 |
| Stage IV at baseline, n (%) | 4 (100) | 5 (100) | 8 (100) | 17 (100) |
ECOG PS, Eastern Cooperative Oncology Group performance status; PD-L1, programmed death ligand 1.
a
Percentages based on patients with known status.
b
Percentages based on patients with known mutations.
c
Other mutations include (but are not limited to) PIK3CA, ERBB2, and BRCA2.