Table 3.
Association between baseline characteristics and response in the week 12 and week 24 analysis populations.a
| Characteristic, n (%) | Week 12 assessment population |
Week 24 assessment population |
||||
|---|---|---|---|---|---|---|
| SD; n = 107 | PR; n = 164 | CR; n = 23 | SD; n = 39 | PR; n = 160 | CR; n = 42 | |
| Sex | ||||||
| Male | 75 (70.1) | 114 (69.5) | 14 (60.9) | 16 (41.0) | 36 (22.5) | 17 (40.5) |
| Female | 32 (29.9) | 50 (30.5) p = 0.673 |
9 (39.1) | 23 (59.0) | 124 (77.5) p = 0.01 |
25 (59.5) |
| Tumour size, b | ||||||
| <2.5 | 18 (16.8) | 32 (19.5) | 17 (73.9) | 6 (15.4) | 27 (16.9) | 28 (66.7) |
| 2.5 to <5 | 36 (33.6) | 49 (29.9) | 5 (21.7) | 14 (35.9) | 39 (24.4) | 10 (23.8) |
| 5 to <10 | 31 (29.0) | 37 (22.5) | 1 (4.4) | 14 (35.9) | 43 (26.9) | 3 (7.1) |
| ≥10 | 22 (20.6) | 46 (28.1) p < 0.001 |
0 | 5 (12.8) | 51 (31.9) p < 0.001 |
1 (2.4) |
| PD-L1 tumour status c | ||||||
| Positive | 66 (77.6) | 124 (91.2) | 17 (89.5) | 22 (75.9) | 114 (87.7) | 32 (91.4) |
| Negative | 19 (22.4) | 12 (8.8) p < 0.05 |
2 (10.5) | 7 (24.1) | 16 (12.3) p = 0.17 |
3 (8.6) |
| ECOG PS | ||||||
| 0 | 77 (72.0) | 118 (71.9) | 22 (95.6) | 30 (76.9) | 112 (70.0) | 38 (90.5) |
| 1 | 30 (28.0) | 46 (28.1) p < 0.05 |
1 (4.4) | 9 (23.1) | 48 (30.0) p < 0.05 |
4 (9.5) |
| Metastatic stage | ||||||
| M0/M1a/M1b | 34 (31.8) | 49 (29.9) | 15 (65.2) | 15 (38.5) | 46 (28.7) | 23 (54.8) |
| M1c | 73 (68.2) | 115 (70.1) p < 0.01 |
8 (34.8) | 24 (61.5) | 114 (71.3) p < 0.01 |
19 (45.2) |
CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; PD-L1, programmed death ligand 1; PR, partial response; SD, stable disease.
Association of baseline characteristics and clinical assessment was evaluated using the chi-square test of independence. p values are not adjusted for multiplicity.
Baseline tumour size was measured by adding the sum of the longest dimensions of all measurable baseline target lesions.
Among those with PD-L1eevaluable tumours (week 12: SD, n = 85; PR, n = 136; CR, n = 19. Week 24: SD, n = 29; PR, n = 130; CR, n = 35). PD-L1 positivity was defined as membranous staining in at least 1% of tumour cells.