Table 1.
Baseline characteristics of the intention-to-treat patient population
| Characteristic | Cemiplimab + chemotherapy (n = 312) | Placebo + chemotherapy (n = 154) | Total (n = 466) |
|---|---|---|---|
| Age, years | |||
| Median (IQR) | 63.0 (57–68) | 63.0 (57–68) | 63.0 (57–68) |
| ≥65, n (%) | 128 (41.0) | 60 (39.0) | 188 (40.3) |
| Sex, n (%) | |||
| Women | 44 (14.1) | 31 (20.1) | 75 (16.1) |
| Men | 268 (85.9) | 123 (79.9) | 391 (83.9) |
| Geographic region, n (%) | |||
| Europe | 270 (86.5) | 138 (89.6) | 408 (87.6) |
| Asia | 42 (13.5) | 16 (10.4) | 58 (12.4) |
| Histology, n (%) | |||
| Non-squamous | 179 (57.4) | 87 (56.5) | 266 (57.1) |
| Squamous | 133 (42.6) | 67 (43.5) | 200 (42.9) |
| PD-L1 expression, n (%) | |||
| <1% | 95 (30.4) | 44 (28.6) | 139 (29.8) |
| 1–49% | 114 (36.5) | 61 (39.6) | 175 (37.6) |
| ≥50% | 103 (33.0) | 49 (31.8) | 152 (32.6) |
| ECOG PS, n (%) | |||
| 0 | 51 (16.3) | 18 (11.7) | 69 (14.8) |
| 1 | 259 (83.0) | 134 (87.0) | 393 (84.3) |
| Brain metastasis, n (%) | 24 (7.7) | 7 (4.5) | 31 (6.7) |
| Cancer stage at screening, n (%) | |||
| Metastatic | 267 (85.6) | 130 (84.4) | 397 (85.2) |
| Locally advanced | 45 (14.4) | 24 (15.6) | 69 (14.8) |
| Smoking history, n (%) | |||
| Current smoker | 173 (55.4) | 75 (48.7) | 248 (53.2) |
| Past smoker | 96 (30.8) | 55 (35.7) | 151 (32.4) |
| Never smoker | 43 (13.8) | 24 (15.6) | 67 (14.4) |
| Previous cancer-related therapy, n (%) | |||
| Systemic adjuvant therapy | 5 (1.6) | 1 (0.6) | 6 (1.3) |
| Systemic other | 1 (0.3) | 0 | 1 (0.2) |
| Radiotherapy | 40 (12.8) | 11 (7.1) | 51 (10.9) |
The intention-to-treat population includes all randomized patients.