Table 1.
Demographic and Baseline Disease Characteristics
| Characteristic | Monotherapy |
Combination |
||
|---|---|---|---|---|
| 1 × 108 CFU n = 6 |
1 × 109 CFU n = 12 |
Total N = 18 |
Total N = 12 |
|
| Age, y, median (range) | 65 (56–73) | 64 (47–79) | 64 (47–79) | 64 (38–77) |
| Sex, n (%) | ||||
| Female | 4 (67) | 7 (58) | 11 (61) | 4 (33) |
| Male | 2 (33) | 5 (42) | 7 (39) | 8 (67) |
| Race, n (%) | ||||
| White | 2 (33) | 9 (75) | 11 (61) | 12 (100) |
| Black or African American | 3 (50) | 2 (17) | 5 (28) | 0 |
| Asian | 0 | 1 (8) | 1 (6) | 0 |
| Unknown | 1 (17) | 0 | 1 (6) | 0 |
| Cancer stage, n (%) | ||||
| IIIA | 0 | 0 | 0 | 1 (8)a |
| IIIB | 1 (17) | 0 | 1 (6) | 1 (8) |
| IV | 5 (83) | 12 (100) | 17 (94) | 10 (83) |
| ECOG PS, n (%) | ||||
| 0 | 2 (33) | 0 | 2 (11) | 5 (42) |
| 1 | 4 (67) | 12 (100) | 16 (89) | 7 (58) |
| Mutation status, n (%) | ||||
| EGFR mutation | 1 (17) | 3 (25) | 4 (22) | 0 |
| KRAS mutation | 1 (17) | 5 (42) | 6 (33) | 2 (17) |
| No mutationb | 2 (33) | 3 (25) | 5 (28) | 9 (75) |
| Unknown | 2 (33) | 1 (8) | 3 (17) | 1 (8) |
| Previous lines of therapy, n (%) | ||||
| 1 | 0 | 0 | 0 | 4 (33) |
| >1 | 6 (100) | 12 (100) | 18 (100) | 8 (67) |
| Previous systemic therapy, n (%) | 6 (100) | 12 (100) | 18 (100) | 12 (100) |
| Chemotherapy | 6 (100) | 12 (100) | 18 (100) | 12 (100) |
| PD-1/PD-L1 inhibitors | 3 (50) | 12 (100) | 15 (83) | 8 (67) |
| Tyrosine kinase inhibitor | 1 (17) | 4 (33) | 5 (28) | 1 (8) |
| Other | 4 (67) | 6 (50) | 10 (56) | 6 (50) |
CFU, colony-forming unit; ECOG PS, Eastern Cooperative Oncology Group performance status; PD-1, programmed cell death protein-1; PD-L1, programmed death-ligand 1.
a
Initial diagnosis was stage IIIA but entered the study as stage IV.
b
Screened for EGFR, KRAS, ROS1, and ALK.