Item | Statistical analysis |
---|
HR / RRa (95%CI) | P-value |
---|
Overall |
OS |
0.67
| 0.47 | 0.94 |
0.02
|
PFS | 0.79 | 0.60 | 1.04 | 0.10 |
Overall |
ORR | 1.26 | 0.93 | 1.72 | 0.14 |
All cause AE | 0.98 | 0.95 | 1.01 | 0.25 |
Grade 3–5 AE | 0.87 | 0.76 | 1.01 | 0.06 |
PD-L1 Highb |
OS | 1.09 | 0.52 | 2.28 | 0.82 |
PFS | 1.55 | 0.84 | 2.84 | 0.16 |
PD-L1 Lowc |
OS |
0.43
| 0.24 | 0.76 |
< 0.01
|
PFS | 0.80 | 0.51 | 1.26 | 0.33 |
PD-L1 Negatived |
OS | 0.74 | 0.40 | 1.38 | 0.35 |
PFS |
0.46
| 0.28 | 0.75 |
< 0.01
|
- Abbreviations: CI confidence interval, HR Hazard ratio, RR Risk ratio, OS overall survival, PFS progression-free survival, ORR objective response rate, AE adverse event, PD-L1 programmed death ligand 1. A statistical test with P-value ≤ 0.05 was considered as significant
- In IMpower131, PD-L1 expression was scored by immunohistochemistry (SP142 assay) in tumor cells (as percentage of PD-L1-expressing tumor cells ≥50%, TC3; ≥5% and < 50%, TC2; ≥1% and < 5%, TC1 and < 1%, TC0) and tumor-infi ltrating immune cells (as percentage of tumor area:≥10%, IC3; ≥5% and < 10%, IC2; ≥1% and < 5%, IC1; and < 1%, IC0). In KEYNOTE-407, PD-L1 expression was scored by immunohistochemistry (22C3 assay) in tumor cells (as percentage of PD-L1-expressing tumor cells TPS ≥50%, ≥1% and <50%, and < 1%)
- aHR is used for OS and PFS evaluation, RR is used for ORR and AE evaluation
- bPD-L1 High is defined as TC3 or IC3 in IMpower131, TPS ≥50% in KEYNOTE-407
- cPD-L1 Low is defined as TC1/2 or IC1/2 in IMpower131, TPS ≥1% and < 50% in KEYNOTE-407
- dPD-L1 Negative is defined as TC0 and IC0 in IMpower131, TPS < 1% in KEYNOTE-407