ORR according to tumor PD-L1 status (cut-off indicates percentage of tumor cells expressing PD-L1)
| PD-L1 positive | PD-L1 negative | P value | |
| ≥1% cut-off | |||
| Patients, n | 88 | 23 | – |
| ORR (95% CI), % | 19.3 (11.7 to 29.1) | 8.7 (1.1 to 28.0) | 0.353 |
| Median PFS (95% CI), months | 4.0 (2.7 to 6.0) | 1.5 (1.4 to 5.4) | – |
| Median OS (95% CI), months | 14.1 (11.2 to 18.2) | 11.3 (1.6 to NE) | – |
| ≥50% cut-off | |||
| Patients, n | 53 | 58 | – |
| ORR (95% CI), % | 22.6 (12.3 to 36.2) | 12.1 (5.0 to 23.3) | 0.207 |
| Median PFS (95% CI), months | 5.4 (2.8 to 9.6) | 2.4 (1.4 to 2.8) | – |
| Median OS (95% CI), months | 14.2 (11.9 to NE) | 13.6 (6.8 to 18.2) | – |
| ≥80% cut-off | |||
| Patients, n | 38 | 73 | – |
| ORR (95% CI), % | 26.3 (13.4 to 43.1) | 12.3 (5.8 to 22.1) | 0.109 |
| Median PFS (95% CI), months | 5.4 (2.7 to 11.1) | 2.7 (1.4 to 4.2) | – |
| Median OS (95% CI), months | 14.2 (12.4 to 16.9) | 14.0 (8.4 to 19.7) | – |
NE, not estimable (not reached); ORR, objective response rate; OS, overall survival; PD-L1, programmed death ligand 1 ; PFS, progression-free survival.