Table 1.
Baseline Patient and Disease Characteristics of the Study Cohorts
| Characteristic | Cohort A, (n = 40) | Cohort B, (n = 9) | Cohort C, (n = 9) | Cohort D, (n = 12) | Cohorts A+B+C, (n = 58) |
|---|---|---|---|---|---|
| Sex, n (%) | |||||
| Male | 31 (77.5) | 6 (66.7) | 5 (55.6) | 5 (41.7) | 42 (72.4) |
| Female | 9 (22.5) | 3 (33.3) | 4 (44.4) | 7 (58.3) | 16 (27.6) |
| Age | |||||
| Median (range), y | 65 (41.0–83.0) | 61 (56.0–79.0) | 60 (40.0–77.0) | 58 (47.0–75.0) | 64 (40.0–83.0) |
| <65 | 20 (50.0) | 6 (66.7) | 5 (55.6) | 9 (75.0) | 31 (53.4) |
| ≥65 | 20 (50.0) | 3 (33.3) | 4 (44.4) | 3 (25.0) | 27 (46.6) |
| Race | |||||
| White | 14 (35.0) | 6 (66.7) | 2 (22.2) | 3 (25.0) | 22 (37.9) |
| Black | 1 (2.5) | 2 (22.2) | 0 | 0 | 3 (5.2) |
| Others/not collected at the site | 25 (62.5) | 1 (11.1) | 7 (77.8) | 9 (75.0) | 33 (56.9) |
| ECOG performance status | |||||
| 0 | 12 (30.0) | 1 (11.1) | 4 (44.4) | 4 (33.3) | 17 (29.3) |
| 1 | 28 (70.0) | 8 (88.9) | 5 (55.6) | 8 (66.7) | 41 (70.7) |
| PD-L1 TPS,a n (%) | |||||
| 1.0% to <50.0% | 7 (17.5) | 0 | 3 (33.3) | 2 (16.7) | 10 (17.2) |
| ≥50% TPS | 1 (2.5) | 1 (11.1) | 0 | 0 | 2 (3.4) |
| <1.0% TPS | 8 (20.0) | 2 (22.2) | 2 (22.2) | 2 (16.7) | 12 (20.7) |
| Missing | 24 (60.0) | 6 (66.7) | 4 (44.4) | 8 (66.7) | 34 (58.6) |
| No. of previous anticancer therapy regimens, n (%) | |||||
| 1 | 0 | 1 (11.1)b | 3 (33.3)b | 2 (16.7)b | 4 (6.9)b |
| 2 | 0 | 1 (11.1) | 0 | 9 (75.0) | 1 (1.7) |
| 3 | 0 | 0 | 0 | 0 | 0 |
| ≥4 | 0 | 0 | 0 | 1 (8.3) | 0 |
| Tumor histology, n (%) | |||||
| Adenocarcinoma | 38 (95.0) | 2 (22.2) | 4 (44.4) | 11 (91.7) | 44 (75.9) |
| Squamous cell carcinoma | 0 (0.0) | 6 (66.7) | 5 (55.6) | 1 (8.3) | 11 (19.0) |
| Adenosquamous carcinoma | 1 (2.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.7) |
| Other | 1 (2.5) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 2 (3.4) |
| Time since the initial cancer diagnosis | |||||
| Median (range), mo | 1.6 (0.5–123.1) | 2.4 (1.0–141.9) | 2.8 (0.9–32.5) | 18.8 (6.3–40.1) | 1.6 (0.5–141.9) |
| Time since documented, locally advanced, inoperable, or metastatic disease | |||||
| Median (range), mo | 1.3 (0.1–50.1) | 2.2 (0.2–36.1) | 1.6 (0.5–2.6) | 15.7 (4.9–33.7) | 1.4 (0.1–50.1) |
ECOG, Eastern Cooperative Oncology Group; PD-L1, programmed death-ligand 1; TPS, tumor proportion score.
a
PD-L1 immunohistochemistry data were generated using clone 22C3.
b
These patients received adjuvant therapy as part of locally advanced therapy that was allowed only if the therapy was completed at least 6 months before the diagnosis of metastatic disease.