Table 1.
Demographic and Disease Characteristics of CHECKMATE-743
| Nivolumab and Ipilimumab N=303 |
Chemotherapy N=302 |
|
|---|---|---|
| Age (years) | ||
| Median | 69 | 69 |
| ≥65 (%) | 232 (77) | 206 (68) |
|
| ||
| Race (%) | ||
| White | 266 (88) | 250 (83) |
| Asian | 26 (9) | 39 (13) |
| American Indian or Alaska Native | 2 (0.7) | 4 (1.3) |
| Other | 9 (3.0) | 9 (3.0) |
|
| ||
| ECOG Performance Status (%) | ||
| 0 | 114 (38) | 128 (42) |
| 1 | 189 (62) | 173 (57) |
| 2 | 0 | 1 (0.3) |
|
| ||
| Disease Stage at Study Entry (%) | ||
| I | 12 (4.0) | 20 (7) |
| II | 23 (8) | 22 (7) |
| III | 103 (34) | 106 (35) |
| IV | 160 (53) | 149 (49) |
| Not reported | 5 (1.7) | 5 (1.7) |
|
| ||
| Histology (%) a | ||
| Epithelioid | 229 (76) | 227 (75) |
| Non-epithelioid | 74 (24) | 75 (25) |
|
| ||
| PD-L1 Expression (%) | ||
| Patients with quantifiable baseline expression | 289 (95) | 297 (98) |
| <1% | 57 (20) | 78 (26) |
| ≥1% | 232 (80) | 219 (74) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; PD-L1, programmed death-ligand 1.
a
Histology based upon interactive response technology (IRT) assessment.
Source: U.S. FDA BLA Multi-disciplinary Review and Evaluation (sBLA 125554 and sBLA 125377) and Approval Package (ref. 27).