Table 1.
Characteristics at baseline by prior cetuximab exposure
| Patients with prior exposure to cetuximab |
Patients without prior exposure to cetuximab |
|||||
|---|---|---|---|---|---|---|
| Characteristic | Nivolumab (n = 147) |
IC (n = 74) |
Total (n = 221) |
Nivolumab (n = 93) |
IC (n = 47) |
Total (n = 140) |
| Age, median (range), y | 60 (31–83) | 62 (32–78) | 60 (31–83) | 59 (29–79) | 59 (28–78) | 59 (28–79) |
| ≥65 y, n (%) | 39 (26.5) | 28 (37.8) | 67 (30.3) | 29 (31.2) | 17 (36.2) | 46 (32.9) |
| ECOG PS, n (%) | ||||||
| 0 | 29 (19.7) | 12 (16.2) | 41 (18.6) | 20 (21.5) | 11 (23.4) | 31 (22.1) |
| 1 | 116 (78.9) | 59 (79.7) | 175 (79.2) | 73 (78.5) | 35 (74.5) | 108 (77.1) |
| 2 | 1 (0.7) | 2 (2.7) | 3 (1.4) | 0 | 1 (2.1) | 1 (0.7) |
| Not reported | 1 (0.7) | 1 (1.4) | 2 (0.9) | 0 | 0 | 0 |
| Site of primary tumor, n (%) | ||||||
| Oral cavity | 62 (42.2) | 42 (56.8) | 104 (47.1) | 46 (49.5) | 25 (53.2) | 71 (50.7) |
| Pharynx | 59 (40.1) | 22 (29.7) | 81 (36.7) | 33 (35.5) | 15 (31.9) | 48 (34.3) |
| Larynx | 24 (16.3) | 9 (12.2) | 33 (14.9) | 10 (10.8) | 5 (10.6) | 15 (10.7) |
| Other | 2 (1.4) | 1 (1.4) | 3 (1.4) | 4 (4.3) | 2 (4.3) | 6 (4.3) |
| Region, n (%) | ||||||
| North America | 57 (38.8) | 26 (35.1) | 83 (37.6) | 44 (47.3) | 18 (38.3) | 62 (44.3) |
| Europe | 75 (51.0) | 39 (52.7) | 114 (51.6) | 34 (36.6) | 23 (48.9) | 57 (40.7) |
| Rest of world | 15 (10.2) | 9 (12.2) | 24 (10.9) | 15 (16.1) | 6 (12.8) | 21 (15.0) |
| Tobacco use, n (%) | ||||||
| Current/former | 118 (80.3) | 53 (71.6) | 171 (77.4) | 73 (78.5) | 33 (70.2) | 106 (75.7) |
| Never | 22 (15.0) | 18 (24.3) | 40 (18.1) | 17 (18.3) | 13 (27.7) | 30 (21.4) |
| Unknown | 7 (4.8) | 3 (4.1) | 10 (4.5) | 3 (3.2) | 1 (2.1) | 4 (2.9) |
| HPV status, n (%) | ||||||
| Positive | 36 (24.5) | 18 (24.3) | 54 (24.4) | 27 (29.0) | 11 (23.4) | 38 (27.1) |
| Negative | 33 (22.4) | 20 (27.0) | 53 (24.0) | 22 (23.7) | 17 (36.2) | 39 (27.9) |
| Unknown | 1 (0.7) | 2 (2.7) | 3 (1.4) | 1 (1.1) | 0 | 1 (0.7) |
| Not reported | 77 (52.4) | 34 (45.9) | 111 (50.2) | 43 (46.2) | 19 (40.4) | 62 (44.3) |
| Tumor PD-L1 expression, n (%) | ||||||
| ≥1% (PD-L1 expressors) | 52 (35.4) | 40 (54.1) | 92 (41.6) | 36 (38.7) | 21 (44.7) | 57 (40.7) |
| <1% (PD-L1 non-expressors) | 50 (34.0) | 20 (27.0) | 70 (31.7) | 23 (24.7) | 18 (38.3) | 41 (29.3) |
| Not quantifiable | 45 (30.6) | 14 (18.9) | 59 (26.7) | 34 (36.6) | 8 (17.0) | 42 (30.0) |
| Lines of prior systemic cancer therapy, n (%) | ||||||
| 1 | 44 (29.9) | 23 (31.1) | 67 (30.3) | 62 (66.7) | 35 (74.5) | 97 (69.3) |
| 2 | 57 (38.8) | 32 (43.2) | 89 (40.3) | 23 (24.7) | 12 (25.5) | 35 (25.0) |
| ≥3 | 46 (31.3) | 19 (25.7) | 65 (29.4) | 8 (8.6) | 0 | 8 (5.7) |
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; HPV, human papillomavirus; IC, investigator’s choice; PD-L1, programmed death ligand 1.