Table 1.
Baseline demographics and clinical characteristics in the overall cohort and by ctDNA METex14 status at baseline.
| Characteristic | Total | ctDNA METex14 status at baseline | ||
|---|---|---|---|---|
| N = 66 | Detectable (n = 46) | Undetectable (n = 20) | p Value | |
| Age, median (IQR) (years) | 68.7 (65.4–74.7) | 69.3 (65.6–76.5) | 67.1 (62.0–68.9) | 0.0327 |
| Sex, n (%) | 0.0871 | |||
| Female | 26 (39) | 15 (33) | 11 (55) | |
| Male | 40 (61) | 31 (67) | 9 (45) | |
| ECOG performance status, n (%) | 0.00473 | |||
| 0 | 12 (18) | 4 (9) | 8 (40) | |
| ⩾1 | 54 (82) | 42 (91) | 12 (60) | |
| Time from primary diagnosis to first dosing, median (IQR) (months) | 4.34 (1.28–11.0) | 3.01 (1.25–11.0) | 5.47 (1.31–13.0) | 0.586 |
| Disease stage, n (%) | 0.6348 | |||
| III | 5 (8) | 3 (7) | 2 (10) | |
| IV | 61 (92) | 43 (94) | 18 (90) | |
| Histology, n (%) | 0.0483 | |||
| PSC | 22 (33) | 19 (41) | 3 (15) | |
| Other NSCLC subtypes | 44 (67) | 27 (59) | 17 (85) | |
| Adenocarcinoma | 39 (59) | 24 (52) | 15 (75) | 0.8352 |
| Adenosquamous carcinoma | 1 (2) | 0 | 1 (5) | |
| Squamous cell carcinoma | 3 (5) | 2 (4) | 1 (5) | |
| NSCLC, not otherwise specified | 1 (2) | 1 (2) | 0 | |
| Tumour sites (⩾20% involvement), n (%) | ||||
| Lung | 62 (94) | 44 (96) | 18 (90) | |
| Lymph node | 61 (92) | 43 (94) | 18 (90) | |
| Pleura | 36 (55) | 27 (59) | 9 (45) | |
| Bone | 39 (59) | 31 (67) | 8 (40) | |
| Pleural effusion | 40 (61) | 33 (72) | 7 (35) | |
| Brain | 15 (23) | 11 (24) | 4 (20) | |
| Adrenal gland | 17 (26) | 15 (33) | 2 (10) | |
| Sum of target lesions’ diameters,a median (IQR) (mm) | ||||
| IRC assessment | 86.0 (49.2–118) | 95.6 (56.7–151) | 51.8 (28.3–62.0) | <0.001 |
| Investigators’ assessment | 69.9 (41.1–103) | 89.0 (56.0–121) | 37.8 (20.3–56.0) | <0.001 |
| Prior systemic treatment for advanced disease, n (%) | 0.474 | |||
| 0 | 25 (38) | 18 (39) | 7 (35) | |
| 1 | 31 (47) | 19 (41) | 12 (60) | |
| 2 | 5 (8) | 4 (9) | 1 (5) | |
| 3 | 3 (5) | 3 (7) | 0 | |
| ⩾4 | 2 (3) | 2 (4) | 0 | |
| Type of prior systemic treatment for advanced disease, n (%) | ||||
| Chemotherapy | 39 (59) | 27 (59) | 12 (60) | |
| Immunotherapy | 3 (5) | 2 (4) | 1 (5) | |
| Targeted therapy | 5 (8) | 4 (9) | 1 (5) | |
| Others | 15 (23) | 11 (24) | 4 (20) | |
| Amount of ctDNA, median (IQR) (ng) | 89.4 (52.1–134) | 107 (71.1–150) | 59.1 (49.4–84.3) | 0.00294 |
| bTMB, median (IQR) | 3.17 (1.06–6.34) | 5.29 (2.11–7.40) | 1.06 (0–2.11) | <0.001 |
For investigators’ assessment, five patients without postbaseline tumour evaluation were excluded from the calculation of average sum of target lesions. For IRC assessment, one additional patient assessed to be without target lesion was excluded; six patients in total were excluded from the calculation of average sum of target lesions by the IRC.
bTMB, blood-based tumour mutational burden; ctDNA, circulating tumour DNA; ECOG, Eastern Cooperative Oncology Group; IQR, interquartile range; IRC, independent review committee; METex14, MET exon 14 skipping alteration; NSCLC, non-small cell lung cancer; PSC, pulmonary sarcomatoid carcinoma.