Table 1.
Baseline characteristics.
| Characteristic | Main efficacy analysis population (n = 68) | Special-interest efficacy analysis population (n = 42) | Safety set (n = 108) |
|---|---|---|---|
| Median age (range), years | 53.0 (23.0–72.0) | 53.5 (28.0–68.0) | 55.0 (23.0–74.0) |
| Male, n (%) | 36 (52.9) | 19 (45.2) | 55 (50.9) |
| Han Chinese, n (%) | 68 (100) | 42 (100) | 108 (100) |
| Eastern Cooperative Oncology Group performance status, n (%) | |||
| 0 | 25 (36.8) | 15 (35.7) | 41 (38.0) |
| 1 | 43 (63.2) | 27 (64.3) | 67 (62.0) |
| Stage M1, n (%) | 67 (98.5) | 42 (100) | 106 (98.1) |
| Prior lines of therapy (chemotherapy), n (%) | |||
| 1 | 27 (39.7) | 6 (14.3) | 30 (27.8) |
| 2 | 16 (23.5) | 13 (31.0) | 29 (26.9) |
| ≥3 | 25 (36.8) | 23 (54.8) | 49 (45.4) |
| Primary tumour type, n (%) | |||
| Colorectal cancer | 53 (77.9) | 28 (66.7) | 73 (67.6) |
| Endometrial cancer | 5 (7.4) | 5 (11.9) | 8 (7.4) |
| Gastric cancer | 4 (5.9) | 3 (7.1) | 8 (7.4) |
| Other | 6 (8.8) | 6 (14.3) | 19 (17.6) |
| Prior antitumour chemotherapy, n (%) | |||
| Any | 68 (100) | 42 (100) | 108 (100) |
| Oxaliplatin | 57 (83.8) | 34 (81.0) | 81 (75.0) |
| Capecitabine | 48 (70.6) | 31 (73.8) | 73 (67.6) |
| Fluorouracil | 37 (54.4) | 27 (64.3) | 54 (50.0) |
| Irinotecan | 34 (50.0) | 31 (73.8) | 52 (48.1) |
| Docetaxel | 7 (10.3) | 6 (14.3) | 11 (10.2) |
| Other prior antitumour systemic therapy, n (%) | |||
| Any | 41 (60.3) | 28 (66.7) | 65 (60.2) |
| Bevacizumab | 28 (41.2) | 20 (47.6) | 43 (39.8) |
| Cetuximab | 7 (10.3) | 7 (16.7) | 12 (11.1) |
| PD-L1a | |||
| Positive | 30 (44.1) | 17 (40.5) | 43 (39.8) |
| Negative | 29 (42.6) | 21 (50.0) | 54 (50.0) |
| Missing | 9 (13.2) | 4 (9.5) | 11 (10.2) |
| Tumour mutational burdenb | |||
| High | 55 (80.9) | 30 (71.4) | 57 (52.8) |
| Low | 8 (11.8) | 7 (16.7) | 41 (38.0) |
| Missing | 5 (7.4) | 5 (11.9) | 10 (9.3) |
PD-L1 programmed death-ligand 1.
aPositive PD-L1 status was defined as a combined positive score ≥1.
bTumour mutational burden (TMB) high was defined as a score ≥10.