Table 1.
Demographics and Baseline Clinical Characteristics in the tTMB-Evaluable Populations in Each Study
| Characteristics | KEYNOTE-189 |
KEYNOTE-407 |
||||
|---|---|---|---|---|---|---|
| tTMB-Evaluable Population (n = 293) | Single-Gene Mutation-Evaluable Population (n = 289) | Total Population (n = 616) | tTMB-Evaluable Population (n = 312) | Single-Gene Mutation-Evaluable Populationa (n = 285) | Total Population (n = 559) | |
| Median age, y (IQR) | 64 (56–69) | 63 (56–69) | 64 (57–69) | 66 (60–71) | 66 (60–71) | 65 (60–71) |
| Male | 166 (56.7) | 162 (56.1) | 363 (58.9) | 252 (80.8) | 230 (80.7) | 455 (81.4) |
| ECOG performance status 1 | 164 (55.9) | 162 (56.1) | 346 (56.2) | 215 (68.9) | 194 (68.1) | 396 (70.8) |
| Former or current smoker | 260 (88.7) | 256 (88.6) | 543 (88.1) | 291 (93.3) | 265 (93.0) | 518 (92.7) |
| PD-L1 TPS | ||||||
| <1% | 99 (33.8) | 98 (33.9) | 190 (30.8) | 111 (35.6) | 100 (35.1) | 194 (34.7) |
| 1%–49% | 910 (31.1) | 90 (31.1) | 186 (30.2) | 117 (37.5) | 111 (38.9) | 207 (37.0) |
| ≥50% | 98 (33.4) | 96 (33.2) | 202 (32.8) | 83 (26.6) | 74 (26.0) | 146 (26.1) |
| Could not be evaluatedb | 5 (1.7) | 5 (1.7) | 38 (6.2) | 0 (0.0) | 0 (0.0) | 12 (2.1) |
ECOG, Eastern Cooperative Oncology Group; IQR, interquartile range; PD-L1 TPS, programmed death-ligand 1 tumor proportion score; tTMB, tissue tumor mutational burden; WES, whole-exome sequencing.
Note: Data are presented as n (%) unless otherwise noted.
a
KRAS and STK11 mutation data were excluded for KEYNOTE-407 because these mutations are rare in squamous NSCLC, and the number of patients with these mutations who also had evaluable WES data from both tumor and normal DNA was small.
b
Specimens had an inadequate number of tumor cells or no tumor cells.