Table 10.
Confirmed response, progression-free survival, and overall survival in patient subgroups defined by PD-L1 expression in tumor or immune cells
| PD-L1+ | PD-L1− | P valuea | Hazard ratio (95% CI) | |
|---|---|---|---|---|
| ≥ 1% Tumor cells, any intensity | ||||
| Prevalence, n | 85 | 51 | – | – |
| ORR (95% CI), n/N1 (%) | 2/85 (2.4 [0.3, 8.2]) | 2/51 (3.9 [0.5, 13.5]) | 0.631 | – |
| Median PFS (95% CI) (weeks) | 5.9 (5.7, 6.0) | 6.0 (5.9, 6.0) | – | 1.183 (0.815, 1.716) |
| PFS rate at 24 weeks (95% CI) (%) | 6.2 (2.1, 13.6) | 12.8 (5.3, 23.8) | – | |
| Median OS (95% CI) (months) | 6.5 (3.7, 9.2) | 8.3 (6.3, ne) | – | 1.331 (0.815, 2.174) |
| OS rate at 12 months (95% CI) (%) | 35.6 (24.2,47.1) | 36.8 (14.8, 59.3) | – | |
| ≥ 5% Tumor cells, any intensity | ||||
| Prevalence, n | 23 | 113 | – | – |
| ORR (95% CI), n/N1 (%) | 1/23 (4.3 [0.1, 21.9]) | 3/113 (2.7 [0.6, 7.6]) | 0.528 | – |
| Median PFS (95% CI) (weeks) | 6.0 (5.7, 7.1) | 5.9 (5.9, 6.0) | – | 0.782 (0.473, 1.290) |
| PFS rate at 24 weeks (95% CI) (%) | 15.5 (3.3, 36.0) | 7.7 (3.6, 13.8) | – | |
| Median OS (95% CI) (months) | 6.5 (2.2, ne) | 7.5 (5.1, 11.3) | – | 1.057 (0.556, 2.010) |
| OS rate at 12 months (95% CI) (%) | ne | 35.9 (23.7, 48.2) | – | |
| ≥ 25% Tumor cells, high intensity (≥ 2+) | ||||
| Prevalence, n | 3 | 133 | – | – |
| ORR (95% CI), n/N1 (%) | 0/3 (0 [0, 70.8]) | 4/133 (3.0 [0.8,7.5]) | 1.000 | – |
| Median PFS (95% CI) (weeks) | 6.0 (5.4, ne) | 5.9 (5.9, 6.0) | – | 0.695 (0.172, 2.813) |
| PFS rate at 24 weeks (95% CI) (%) | ne | 8.6 (4.5, 14.5) | – | |
| Median OS (95% CI) (months) | 9.2 (ne, ne) | 6.8 (4.9, 10.8) | – | 0.441 (0.061, 3.177) |
| OS rate at 12 months (95% CI) (%) | 0 (ne, ne) | 36.3 (25.0, 47.6) | – | |
| ≥ 10% Tumor-associated immune cells, any intensity | ||||
| Prevalence, n | 12 | 124 | – | – |
| ORR (95% CI), n/N1 (%) | 2/12 (16.7 [2.1, 48.4]) | 2/124 (1.6 [0.2, 5.7]) | 0.039 | – |
| Median PFS (95% CI) (weeks) | 6.1 (2.3, 24,1) | 5.9 (5.9, 6.0) | – | 0.656 (0.341, 1.263) |
| PFS rate at 24 weeks (95% CI) (%) | 25.0 (6.0, 50.5) | 7.0 (3.2, 12.9) | – | |
| Median OS (95% CI) (months) | 11.3 (1.4, ne) | 6.8 (4.7, 9.2) | – | 0.620 (0.250, 1.541) |
| OS rate at 12 months (95% CI) (%) | 33.3 (1.7, 74.4) | 37.4 (27.4, 47.4) | – | |
ne not estimable, N1 number of patients with evaluable PD-L1 expression, ORR objective response rate, OS overall survival, PD-L1 programmed death-ligand 1, PFS progression-free survival
aFisher’s exact test