Table 4.
Confirmed responses, progression-free survival, and overall survival associated with PD-L1 expression
| PD-L1 expression (n=142) | PD-L1+ | PD-L1− | P value* | Hazard ratio (95% CI) |
|---|---|---|---|---|
| ≥1% tumour cells, any intensity | ||||
| Prevalence, n | 122 | 20 | — | — |
| Objective response rate, n/N1 (% [95% CI]) | 17/122 (14 [8–21]) | 2/20 (10 [1–32]) | >0·99 | — |
| Median progression-free survival (95% CI), weeks | 12·0 (10·4–17·7) | 5·9 (5·6–7·1) | — | — |
| Progression-free survival rate at 48 weeks (95% CI), % | 21 (13–30) | 5 (0–21) | — | 0·45 (0·27–0·75) |
| Median overall survival (95% CI), months | 8·9 (8·0–NE) | 4·6 (2·8–NE) | — | — |
| Overall survival rate at 12 months (95% CI), % | 39 (26–52) | 36 (14–58) | — | 0·64 (0·34–1·20) |
| ≥5% tumour cells, any intensity | ||||
| Prevalence, n | 84 | 58 | — | — |
| Objective response rate, n/N1 (% [95% CI]) | 12/84 (14 [8–24]) | 7/58 (12 [5–23]) | 0·81 | — |
| Median progression-free survival (95% CI), weeks | 11·9 (6·7–18·3) | 7·8 (6·0–12·0) | — | — |
| Progression-free survival rate at 48 weeks (95% CI), % | 25 (16–36) | 10 (3–21) | — | 0·70 (0·48–1·02) |
| Median overall survival (95% CI), months | 10·6 (7·9–NE) | 8·4 (5·6–NE) | — | — |
| Overall survival rate at 12 months (95% CI), % | 39 (22–55) | 37 (22–52) | — | 0·79 (0·48–1·28) |
| ≥25% tumour cells, moderate-to-high intensity | ||||
| Prevalence, n | 53 | 89 | — | — |
| Objective response rate, n/N1 (% [95% CI]) | 9/53 (17 [8–30]) | 10/89 (11 [6–20]) | 0·45 | — |
| Median progression-free survival (95% CI), weeks | 11·9 (6·1–22·9) | 10·79 (6·0–13·7) | — | — |
| Progression-free survival rate at 48 weeks (95% CI), % | 28 (16–41) | 15 (8–24) | — | 0·79 (0·53–1·18) |
| Median overall survival (95% CI), months | 8·44 (6·0–11·1) | 8·57 (7·16–NE) | — | — |
| Overall survival rate at 12 months (95% CI), % | 28 (12–47) | 48 (35–60) | — | 1·14 (0·70–1·85) |
| ≥10% tumour-associated immune cells in hotspots, any intensity | ||||
| Prevalence, n | 27 | 115 | — | — |
| Objective response rate, n/N1 (% [95% CI]) | 4/27 (15 [4–34]) | 15/115 (13 [8–21]) | 0·76 | — |
| Median progression-free survival (95% CI), weeks | 8·4 (5·7–15·1) | 11·3 (6·7–15·3) | — | — |
| Progression-free survival rate at 48 weeks (95% CI), % | NE | 19 (11–28) | — | 1·19 (0·74–1·92) |
| Median overall survival (95% CI), months | 8·5 (3·9–NE) | 8·9 (7·9–NE) | — | — |
| Overall survival rate at 12 months (95% CI), % | 30 (10–53) | 41 (28–54) | — | 1·20 (0·68–2·14) |
N1, number of patients with tumours evaluable for PD-L1 expression; NE, not estimable; PD-L1, programmed death ligand 1.
*
Fisher exact test; P values were calculated based on the binary comparison of positive vs negative.