Table 1.
Baseline Characteristics of Patients With aNSCLC by KRAS Mutational Status and Treatment Line
| 1L | 2L | |||||
|---|---|---|---|---|---|---|
| Characteristic, n (%) | KRAS WT n = 1344 | KRAS G12C n = 454 | p | KRAS WT n = 782 | KRAS G12C n = 234 | p |
| Sex | ||||||
| Female | 488 (36.3) | 281 (61.9) | < 0.001 | 296 (37.9) | 143 (61.1) | < 0.001 |
| Male | 856 (63.7) | 173 (38.1) | 486 (62.1) | 91 (38.9) | ||
| Age at line start | ||||||
| 18–64 years | 479 (35.6) | 169 (37.2) | 0.572 | 292 (37.3) | 92 (39.3) | 0.591 |
| ≥ 65 years | 865 (64.4) | 285 (62.8) | 490 (62.6) | 142 (60.7) | ||
| Race | ||||||
| White | 955 (71.1) | 327 (72.0) | 0.108 | 546 (69.8) | 167 (71.4) | 0.598 |
| Asian | 12 (0.9) | ≤5 (≤1.1) | 9 (1.2) | ≤5 (≤2.1) | ||
| Black or African American | 107 (8.0) | 25 (5.5) | 63 (8.1) | 17 (7.3) | ||
| Hispanic or Latino | ≤5 (≤1.1) | |||||
| Other | 167 (12.4) | 61 (13.4) | 113 (14.5) | 29 (12.4) | ||
| Missing | 103 (7.7) | 35 (7.7) | 51 (6.5) | ≥16 (≥6.8) | ||
| Smoking status | ||||||
| Previous or current | 1255 (93.4) | 445 (98.0) | < 0.001 | 727 (93.0) | 228 (97.4) | 0.018 |
| Stage at initial diagnosis before progressing to advanced disease | ||||||
| Stage I at initial diagnosis | 112 (8.3) | 52 (11.5) | 0.005 | 65 (8.3) | 34 (14.5) | 0.001 |
| Stage II at initial diagnosis | 80 (6.0) | ≥30 (≥6.6) | 46 (5.9) | ≥7 (≥2.9) | ||
| Stage III at initial diagnosis | 326 (24.3) | 74 (16.3) | 221 (28.3) | 41 (17.5) | ||
| Stage IV at initial diagnosis | 808 (60.1) | 293 (64.5) | 440 (56.3) | 147 (62.8) | ||
| Unknown stage at initial diagnosis | 18 (1.3) | ≤5 (≤1.1) | 10 (1.3) | ≤5 (≤2.1) | ||
| Histology | ||||||
| Non-squamous | 745 (55.4) | 415 (91.4) | < 0.001 | 411 (52.6) | 214 (91.5) | < 0.001 |
| Squamous | 532 (39.6) | 19 (4.2) | 337 (43.1) | 9 (3.8) | ||
| NOS | 67 (5.0) | 20 (4.4) | 34 (4.3) | 11 (4.7) | ||
| TMBa | ||||||
| High | 638 (47.5) | 174 (38.3) | < 0.001 | 171 (21.9) | 38 (16.2) | < 0.001 |
| Low | 689 (51.3) | 235 (51.8) | 599 (76.6) | 171 (73.1) | ||
| Missing or unknown | 17 (1.3) | 45 (9.9) | 12 (1.5) | 25 (10.7) | ||
| PD-L1b | ||||||
| High (≥50%) | 139 (10.3) | 83 (18.3) | < 0.001 | 73 (9.3) | 35 (15.0) | 0.003 |
| Low (1–49%) | 208 (15.5) | 69 (15.2) | 116 (14.8) | 40 (17.1) | ||
| Negative (< 1%) | 228 (17.0) | 46 (10.1) | 134 (17.1) | 21 (9.0) | ||
| Missing or unknown | 769 (57.2) | 256 (56.4) | 459 (58.7) | 138 (59.0) | ||
| Cancer type | ||||||
| De novo | 809 (60.2) | 294 (64.8) | 0.095 | 441 (56.4) | 147 (62.8) | 0.095 |
| Recurrent | 535 (39.8) | 160 (35.2) | 341 (43.6) | 87 (37.2) | ||
| ECOG PS (Eastern Cooperative Oncology Group performance status) | ||||||
| 0 | 326 (24.3) | 110 (24.2) | 0.231 | 149 (19.1) | 49 (20.9) | 0.560 |
| 1 | 544 (40.5) | 163 (35.9) | 371 (47.4) | 106 (45.3) | ||
| ≥ 2 | 193 (14.3) | 76 (16.8) | 143 (18.3) | 45 (19.2) | ||
| Missing or unknown | 361 (20.5) | 105 (23.1) | 119 (15.2) | 34 (14.5) | ||
| Drug category | ||||||
| Chemotherapy | 937 (69.7) | 281 (61.9) | 0.003 | 272 (34.8) | 83 (35.5) | 0.379 |
| CIT | 145 (10.8) | 72 (15.9) | 445 (56.9) | 138 (59.0) | ||
| Combination CIT and chemotherapy | 262 (19.5) | 101 (22.2) | 65 (8.3) | 13 (5.6) | ||
| STK11 and/or KEAP1 mutational status | ||||||
| STK11 WT-KEAP1 WT | 881 (65.6) | 240 (52.9) | < 0.001 | 515 (65.9) | 125 (53.4) | 0.022 |
| mSTK11-mKEAP1 | 133 (9.9) | 65 (14.3) | 0.012 | 78 (10.0) | 31 (13.2) | 0.194 |
| mSTK11-KEAP1 WT | 129 (9.0) | 59 (13.0) | 0.05 | 72 (9.2) | 30 (12.8) | 0.136 |
| STK11 WT-mKEAP1 | 201 (15.0) | 32 (7.0) | < 0.001 | 117 (15.0) | 19 (8.1) | 0.010 |
| Treatment Start Year Group | ||||||
| 2009–2015 | 134 (10.0) | 54 (11.9) | 0.176 | 31 (4.0) | 15 (6.4) | 0.238 |
| 2016–2017 | 377 (28.1) | 137 (30.2) | 215 (27.5) | 73 (31.2) | ||
| 2018–2020 | 833 (62.0) | 263 (57.9) | 536 (68.5) | 146 (62.4) | ||
1L first line; 2L second line; aNSCLC advanced non-small cell lung cancer; CIT cancer immunotherapy; ECOG PS Eastern Cooperative Oncology Group performance status; mt mutation; NOS not otherwise specified; PD-L1 programmed death-ligand 1; TMB tumor mutational burden; WT wild type
aTMB was categorized as high or low using a different threshold (mutations [mut]/megabase[Mb]) for each treatment line; TMB high was defined as ≥10 mut/Mb in the 1L and ≥ 16 mut/Mb in the 2L.
bPD-L1high was defined as Tumor Proportion Score ≥ 50%, low 1–49% and negative < 1%