Table 1.
Patient Demographics and Baseline Characteristics
| Demographic or Characteristics | Part A Vidutolimod + Atezolizumab n = 13 |
Part B Vidutolimod + Atezolizumab + RT n = 16 |
|---|---|---|
| Median age, y (range) | 65 (48–75) | 57 (44–76) |
| Male | female, n (%) | 6 (46.2) | 7 (53.8) | 10 (62.5) | 6 (37.5) |
| ECOG PS 0 | 1, n (%) | 4 (30.8) | 9 (69.2) | 3 (18.8) | 13 (81.3) |
| Baseline disease location(s),a n (%) | ||
| Any lung | 11 (84.6) | 16 (100) |
| Lung only | 3 (23.1) | 1 (6.3) |
| Lung and lymph nodes only | 3 (23.1) | 4 (25.0) |
| Any visceral disease | 5 (38.5) | 4 (25.0) |
| Any CNS disease | 0 | 1 (6.3) |
| Any bone disease | 5 (38.5) | 8 (50.0) |
| Any liver disease | 2 (15.4) | 1 (6.3) |
| PD-L1 status, n (%) | ||
| Negative | 5 (38.5) | 4 (25.0) |
| Positive | 5 (38.5) | 6 (37.5) |
| Unknown | 3 (23.1) | 6 (37.5) |
| Median number of prior systemic cancer treatment regimens, n (range)b | 3 (1–5) | 3 (1–6) |
| 1 Prior therapy, n (%) | 1 (7.7) | 3 (18.8) |
| 2–3 Prior therapies, n (%) | 7 (53.8) | 9 (56.3) |
| ≥4 Prior therapies, n (%) | 5 (38.5) | 4 (25.0) |
| Prior anti–PD-1 or PD-L1 treatment, n (%) | 13 (100) | 16 (100) |
| Monotherapy, n (%) | 11 (84.6) | 6 (37.5) |
| Combination therapy, n (%) | 2 (15.4) | 12 (75.0) |
| Prior anti–PD-1/PD-L1 best response, n (%) | ||
| PR | 1 (7.7) | 1 (6.3) |
| Stable disease | 3 (23.1) | 11 (68.8) |
| PD | 9 (69.2) | 4 (25.0) |
CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group performance status; PD, progressive disease; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; PR, partial response; RECIST v1.1, Response Evaluation in Solid Tumors, version 1.1; RT, radiation therapy.
a
Based on screening RECIST v1.1 target and nontarget lesions. Patients with more than one baseline disease location are included in multiple categories. “Any” indicates that patients may have had lesions in other areas.
b
Combination treatments, including those administered on the same day, are counted as a single prior treatment regimen.