Table 4.
Baseline characteristics in the nivolumab arm among the ITT population and 2-year survivors.
| Patients, n (%) | Nivolumab |
|
|---|---|---|
| ITT (n = 240) | 2-year survivors (n = 37) | |
| ECOG performance status | ||
| 0 | 49 (20.4) | 10 (27.0) |
| ≥1 | 190 (79.2) | 27 (73.0) |
| Not reported | 1 (0.4) | 0 |
| Tobacco use | ||
| Current/former | 191 (79.6) | 31 (83.8) |
| Never | 39 (16.3) | 6 (16.2) |
| Unknown | 10 (4.2) | 0 |
| Prior cetuximab use | 147 (61.3) | 19 (51.4) |
| Yes | 147 (61.3) | 19 (51.4) |
| No | 93 (38.8) | 18 (48.6) |
| Number of lines of prior systemic therapy | ||
| 1 | 106 (44.2) | 14 (37.8) |
| 2 | 80 (33.3) | 16 (43.2) |
| ≥3 | 54 (22.5) | 7 (18.9) |
| Site of primary tumor | ||
| Oral cavity | 108 (45.0) | 13 (35.1) |
| Pharynx | 92 (38.3) | 17 (45.9) |
| Larynx | 34 (14.2) | 5 (13.5) |
| Other | 6 (2.5) | 2 (5.4) |
| Tumor PD-L1 expression | ||
| Expressors (≥1%) | 96 (40.0) | 16 (43.2) |
| Non-expressors (< 1%) | 76 (31.7) | 15 (40.5) |
| Tumor HPV status | ||
| Positive | 64 (26.7) | 12 (32.4) |
| Negative | 56 (23.3) | 13 (35.1) |
| Unknown/not reported | 120 (50.0) | 12 (32.4) |
ECOG, Eastern Cooperative Oncology Group; HPV, human papillomavirus; ITT, intent-to-treat; PD-L1, programmed death ligand 1.