Table 1.
Baseline Demographics, Treatment Arm, and Clinical Characteristics per Tumor Cell PD-L1 Expression Levels and Percentage Levels of CD8+ Tumor Infiltrating Cell That Are PD-1+TIM-3−LAG-3−
| Characteristic | Total (n=167) | TC PD-L1 | % of CD8+PD-1+TIM-3−LAG-3− TIC | ||
|---|---|---|---|---|---|
| ≥1% n=19 | <1%n=121 | High (≥36%) n=74 | Low (<36%) n=24 | ||
| Age | |||||
| Median (Min, Max) | 61.0(37.0, 81.0) | 61 44, 76 | 60 37, 81 | 59.5 38.0, 81.0 | 60.037.0, 78.0 |
| Gender, (%) | |||||
| Female | 46 (27.5) | 7 (36.8) | 30 (24.8) | 22 (29.7) | 4 (16.7) |
| Male | 121 (72.5) | 12 (63.2) | 91 (75.2) | 52 (70.3) | 20 (83.3) |
| Race | |||||
| ASIAN | 7 (4.2) | 1 (5.3) | 4 (3.3) | 2 (2.7) | - |
| BLACK | 3 (1.8) | 1 (5.3) | 1 (0.8) | 1 (1.4) | 1 (4.2) |
| OTHER | 1 (0.6) | - | 1 (0.8) | - | - |
| WHITE | 156 (93.4) | 17 (89.5) | 115 (95.0) | 71 (95.9) | 23 (95.8) |
| Ethnicity | |||||
| Non-Hispanic | 159 (95.2) | 18 (94.7) | 116 (95.9) | 71 (95.9) | 23 (95.8) |
| Not Reported | 8 (4.8) | 1 (5.3) | 5 (4.1) | 3 (4.1) | 1 (4.2) |
| Treatment Arm, niv. dose | |||||
| 0.3 mg/kg | 59 (35.3) | 6 (31.6) | 44 (36.4) | 24 (32.4) | 10 (41.7) |
| 2 mg/kg | 54 (32.3) | 8 (42.1) | 35 (28.9) | 26 (35.1) | 6 (25.0) |
| 10 mg/kg | 54 (32.3) | 5 (26.3) | 42 (34.7) | 24 (32.4) | 8 (33.3) |
| MSKCC Risk Category | |||||
| Favorable | 54 (32.7) | 5 (27.8) | 41 (34.2) | 29 (39.2) | 4 (16.7) |
| Intermediate | 68 (41.2) | 6 (33.3) | 51 (42.5) | 25 (33.8) | 12 (50.0) |
| Poor | 43 (26.1) | 7 (38.9) | 28 (23.3) | 20 (27.0) | 8 (33.3) |
| Missing | 2 | 1 | 1 | - | - |
| ECOG PS | |||||
| 0 | 38 (22.9) | 5 (27.8) | 26 (21.5) | 16 (21.9) | 3 (12.5) |
| 1 | 108 (65.1) | 11 (61.1) | 81 (66.9) | 50 (68.5) | 15 (62.5) |
| 2 | 20 (12.1) | 2 (11.11) | 14 (11.6) | 7 (9.6) | 6 (25.0) |
| Missing | 1 | 1 | - | 1 | - |
| Number of Prior Therapy Adv/Met Setting | |||||
| 1 | 50 (29.9) | 5 (26.3) | 34 (28.1) | 24 (32.4) | 9 (37.5) |
| >1 | 117 (70.1) | 14 (73.7) | 87 (71.9) | 50 (67.6) | 15 (62.5) |
| Number of Prior Anti-Angiogenic Therapy | |||||
| 1 | 104 (62.3) | 13 (68.4) | 72 (59.5) | 50 (67.6) | 15 (62.5) |
| >1 | 63 (37.7) | 6 (31.6) | 49 (40.5) | 24 (32.4) | 9 (37.5) |
Abbreviations: CD8, cluster of differentiation 8; ECOG PS: eastern cooperative oncology group performance status; LAG-3, lymphocyte activation protein-3; MSKCC: Memorial Sloan Kettering Cancer Center; niv., nivolumab; PD-1, programmed cell death 1; PD-L1, programmed cell death 1 ligand 1; TC, tumor cell; TIC, tumor infiltrating cell; TIM-3, T-cell immunoglobulin and mucin-domain containing-3.