Table 1.
Baseline Characteristics of Patients with a High Tumor Mutational Burden.*
| Characteristic | Nivolumab plus Ipilimumab (N = 139) | Chemotherapy (N = 160) |
|---|---|---|
| Age—yr | ||
| Median | 64 | 64 |
| Range | 41–87 | 29–80 |
| Age category — no. (%) | ||
| <65 yr | 73 (52.5) | 83 (51.9) |
| ≥65 to <75 yr | 53 (38.1) | 63 (39.4) |
| ≥75yr | 13 (9.4) | 14 (8.8) |
| Sex—no. (%) | ||
| Male | 98 (70.5) | 106 (66.2) |
| Female | 41 (29.5) | 54 (33.8) |
| Region — no. (%) | ||
| North America | 14 (10.1) | 16 (10.0) |
| Europe | 77 (55.4) | 87 (54.4) |
| Asia | 21 (15.1) | 32 (20.0) |
| Rest of world† | 27 (19.4) | 25 (15.6) |
| ECOG performance-status score — no. (%)‡ | ||
| 0 | 56 (40.3) | 49 (30.6) |
| 1 | 82 (59.0) | 110 (68.8) |
| ≥2 | 1 (0.7) | 1 (0.6) |
| Smoking status — no. (%) | ||
| Current or former smoker | 130 (93.5) | 146 (91.2) |
| Never smoked | 7 (5.0) | 11 (6.9) |
| Unknown | 2 (1.4) | 3 (1.9) |
| Tumor histologic type — no. (%) | ||
| Squamous | 45 (32.4) | 55 (34.4) |
| Nonsquamous | 94 (67.6) | 105 (65.6) |
| PD-L1 expression level — no. (%) | ||
| <1% | 38 (27.3) | 48 (30.0) |
| ≥1% | 101 (72.7) | 112 (70.0) |
A high tumor mutational burden was defined as at least 10 mutations per megabase. No significant differences between treatment groups were noted for the baseline characteristics. Percentages may not total 100 because of rounding. PD-L1 denotes programmed death ligand 1.
Included are Argentina, Australia, Brazil, Chile, Colombia, Israel, Lebanon, Mexico, Peru, Turkey, and South Africa.
Eastern Cooperative Oncology Group (ECOG) performance-status scores range from 0 to 5, with higher scores indicating greater disability. Two patients (one in each group) with a score of 1 at screening had an increase in the score between screening and the baseline evaluation at the time of the first dose.