TABLE 1.
Baseline demographic and disease characteristics a .
| Characteristic | Overall study population | Japanese subgroup | ||||
|---|---|---|---|---|---|---|
| Cemiplimab (n = 304) | Chemotherapy (n = 304) | Overall (N = 608) | Cemiplimab (n = 29) | Chemotherapy (n = 27) | Overall (N = 56) | |
| Age | ||||||
| Median (range), years | 51.0 (22–81) | 50.0 (24–87) | 51.0 (22–87) | 57.0 (34–78) | 52.0 (30–81) | 57.0 (30–81) |
| <65 years, n (%) | 269 (88.5) | 264 (86.8) | 533 (87.7) | 19 (65.5) | 19 (70.4) | 38 (67.9) |
| Body weight, median (range), kg | 61.8 (35.9–128.7) | 61.2 (35.0–120.0) | 61.6 (35.0–128.7) | 52.7 (35.9–84.2) | 50.0 (36.6–81.7) | 51.5 (35.9–84.2) |
| Body mass index, median (range) kg/m2 | 23.5 (14.2–49.0) | 23.7 (14.2–46.6) | 23.6 (14.2–49.0) | 21.5 (15.9–36.8) | 19.8 (15.0–32.7) | 21.3 (15.0–36.8) |
| Region of enrollment, n (%) | ||||||
| Asia | 83 (27.3) | 83 (27.3) | 166 (27.3) | 29 (100) | 27 (100) | 56 (100) |
| North America | 32 (10.5) | 34 (11.2) | 66 (10.9) | NA | NA | NA |
| Rest of the world | 189 (62.2) | 187 (61.5) | 376 (61.8) | NA | NA | NA |
| ECOG performance status, n (%) | ||||||
| 0 | 142 (46.7) | 141 (46.4) | 283 (46.5) | 22 (75.9) | 19 (70.4) | 41 (73.2) |
| 1 | 162 (53.3) | 163 (53.6) | 325 (53.5) | 7 (24.1) | 8 (29.6) | 15 (26.8) |
| Histology/cytology, n (%) | ||||||
| SCC | 240 (78.9) | 233 (76.6) | 473 (77.8) | 27 (93.1) | 26 (96.3) | 53 (94.6) |
| AC | 64 (21.1) | 71 (23.4) | 135 (22.2) | 2 (6.9) | 1 (3.7) | 3 (5.4) |
| Extent of disease, n (%) | ||||||
| Metastatic | 284 (93.4) | 290 (95.4) | 574 (94.4) | 28 (96.6) | 24 (88.9) | 52 (92.9) |
| Recurrent or persistent | 20 (6.6) | 14 (4.6) | 34 (5.6) | 1 (3.4) | 3 (11.1) | 4 (7.1) |
| Prior lines of therapy for recurrent or metastatic disease, n (%) | ||||||
| 1 | 177 (58.2) | 169 (55.6) | 346 (56.9) | 12 (41.4) | 12 (44.4) | 24 (42.9) |
| >1 | 124 (40.8) | 135 (44.4) | 259 (42.6) | 17 (58.6) | 15 (55.6) | 32 (57.1) |
| Prior bevacizumab use, n (%) b | ||||||
| Yes | 148 (48.7) | 149 (49.0) | 297 (48.8) | 18 (62.1) | 15 (55.6) | 33 (58.9) |
| No | 156 (51.3) | 155 (51.0) | 311 (51.2) | 11 (37.9) | 12 (44.4) | 23 (41.1) |
| Prior paclitaxel use, n (%) | ||||||
| Yes | 273 (89.8) | 287 (94.4) | 560 (92.1) | 29 (100) | 26 (96.3) | 55 (98.2) |
| No | 31 (10.2) | 17 (5.6) | 48 (7.9) | 0 | 1 (3.7) | 1 (1.8) |
| Prior lines of cancer systemic therapy, n (%) | ||||||
| 1 | 81 (26.6) | 66 (21.7) | 147 (24.2) | 3 (10.3) | 2 (7.4) | 5 (8.9) |
| >1 | 223 (73.4) | 238 (78.3) | 461 (75.8) | 26 (89.7) | 25 (92.6) | 51 (91.1) |
| Number of patients with any prior cancer‐related radiotherapy, n (%) | 262 (86.2) | 259 (85.2) | 521 (85.7) | 25 (86.2) | 24 (88.9) | 49 (87.5) |
Abbreviations: AC, adenocarcinoma or adenosquamous carcinoma; ECOG, Eastern Cooperative Oncology Group; NA, not applicable; SCC, squamous cell carcinoma.
a
Data cutoff date: January 4, 2021.
b
Based on interactive web response system data.