Table 2.
Primary efficacy data for the NSCLC cohorts (N = 495) from KEYNOTE-001 [50]
| Cohort | ORR |
|---|---|
| % (95% CI) | |
| All (N = 495)a | 19.4 (16.0–23.2) |
| Previously treated (n = 394)b | 18.0 (14.4–22.2) |
| Previously untreated (n = 101)c | 24.8 (16.7–34.3) |
| PD-L1+ TPS ≥50% (N = 73)d | 45.2 (33.5–57.3)* |
| Previously treated (n = 57) | 43.9 (30.7–57.6) |
| Previously untreated (n = 16) | 50.0 (24.7–75.3) |
| PD-L1+ TPS 1–49% (n = 103) | 16.5 (9.9–25.1) |
| PD-L1+ TPS <1% (n = 28) | 10.7 (2.3–28.2) |
a
Cohorts C, F1, and F2.
b
Cohorts C and F2.
c
Cohort F1.
d
Data for the validation set.
*
Significantly greater than PD-L1+ TPS 1–49% (P < 0.001) and PD-L1+ TPS <1% (P = 0.01).
NSCLC, non-small cell lung cancer; PD-L1+, positive for expression of programmed death ligand 1; TPS, tumor proportion score (percentage of PD-L1+ tumor cells).