TABLE 1.
Patient baseline demographic and clinical characteristics. a
| Covariate | Pooled tTMB <16 mut/Mb (n = 811) | Pooled tTMB ≥16 mut/Mb (n = 175) | P‐value |
|---|---|---|---|
| Median age (range), years | 65 (20‐88) | 65 (37‐89) | .1211 |
| Median albumin (range), g/L | 40 (0.035‐270) | 39 (0.039‐49) | .3577 |
| Anti‐drug antibody positive, n (%) | 216 (32.9) | 48 (29.3) | .3791 |
| Missing records, n (%) | 154 (19.0) | 11 (6.3) | — |
| Median baseline SLD (range), mm | 60 (10‐310) | 58 (11.1‐309) | .5840 |
| Median body weight (range), kg | 74 (37‐149) | 75 (35.4‐149) | .5018 |
| White, n (%) | 624 (76.9) | 145 (82.9) | .7337 |
| Median C‐reactive protein (range), mg/L | 12.6 (0.26‐318) | 15.6 (0.41‐288) | .0373* |
| Missing records, n (%) | 223 (27.5) | 22 (12.6) | — |
| Median ECOG PS (range) | 1 (0‐2) | 1 (0‐2) | .6248 |
| Female, n (%) | 307 (37.9) | 48 (27.4) | .0092** |
| Median lactate dehydrogenase (range), U/L | 223 (0.83‐3137) | 209 (77‐1407) | .0521 |
| Median prior lines of therapy (range) | 2 (1‐4) | 2 (1‐3) | .8991 |
| Missing records, n (%) | 99 (12.2) | 19 (10.9) | — |
| Median neutrophil to lymphocyte ratio (range) | 3.81 (0.865‐59.7) | 4.00 (0.965‐46.5) | .3695 |
| Median no. of metastatic sites (range) | 2 (0‐7) | 2 (0‐7) | .6914 |
| Median no. of tumor types present b | 16 | 8 | — |
| PD‐L1 TC2/3, n (%) c | 147 (18.2) | 45 (25.7) | .0239* |
| Missing records, n (%) | 5 (0.6) | — | — |
| PD‐L1 IC2/3, n (%) d | 331 (40.8) | 83 (47.4) | .1078 |
| Median tTMB (range), mut/Mb | 7.02 (0‐15.8) | 22.8 (16.7‐403) | <.0001**** |
Significance of the difference between patient groups at baseline was evaluated using a Chi‐square test for categorical variables, and Mann‐Whitney test for continuous variable, P < .05, P < .01, and P < .0001 are denoted by *, **, and **** respectively.
ECOG PS, Eastern Cooperative Oncology Group performance score; IC, tumor‐infiltrating immune cell; mUC, metastatic urothelial carcinoma; NSCLC, non‐small cell lung cancer; PD‐L1, programmed death‐ligand 1; SLD, sum of longest diameter; TC, tumor cell; tTMB, tissue tumor mutational burden.
Distribution of patients by tTMB status included 50% NSCLC, 42.4% mUC, and 7.27% encompassing >13 tumor types.
See Table S2 for tumor types within each subgroup.
PD‐L1 expression on ≥5% of TC.
≥5% of the tumor area occupied by PD‐L1–expressing IC per VENTANA SP142 immunohistochemistry assay.