Table 1. Summary of results of trails concerning PD-L1 inhibitors.
| Study | Drugs | Subgroup | No. | ORR (%) | mPFS (month) | mOS (month) |
| PD-L1, programmed cell death ligand 1; ORR, objective response rate; mPFS, median progression-free survival; mOS, median overall survival; aTNBC, advanced triple-negative breast cancer; MBC, metastatic breast cancer; ITT, intention-to-treatment; NA, not available; CPS, combined positive score; IC, immune cell: TILs, tumor infiltrating lymphocytes; #, the first interim analysis; ##, the second interim analysis; *, final OS analysis. | ||||||
| SAFIR02-
BREAST (21) |
Durvalumab vs. maintenance chemotherapy | MBC | 131 vs. 68 | NA | 2.7 vs. 4.6 | 21.8 vs. 17.9 |
| TNBC | 47 vs. 35 | NA | NA | 21.2 vs. 14.0 | ||
| PD-L1+IC≥1% | 18 vs. 14 | NA | NA | 27.3 vs. 12.1 | ||
| PD-L1+IC<1% | 17 vs. 12 | NA | NA | 19.5 vs. 14.0 | ||
| JAVELIN
(22) |
Avelumab | MBC | 168 | 3.0 | 5.9 | 8.1 |
| TNBC | 58 | 5.2 | 5.9 | 9.2 | ||
| PD-L1+IC≥10% (MBC) | 12 | 16.7 | 6.1 | 11.3 | ||
| PD-L1+IC<10% (MBC) | 124 | 1.6 | 5.9 | 6.8 | ||
| PD-L1+TC≥1% vs. <1% (MBC) | 85 vs. 51 | 2.4 vs. 3.9 | 5.9 vs. 6.0 | 6.5 vs. 8.3 | ||
| PD-L1+TC≥5% vs. <5% (MBC) | 23 vs. 113 | 4.3 vs. 2.7 | 6.0 vs. 5.9 | 6.5 vs. 7.5 | ||
| PD-L1+TC≥25% vs. <25% (MBC) | 3 vs. 133 | 0 vs. 3.0 | 6.0 vs. 5.9 | 9.2vs. 6.8 | ||
| PD-L1+IC≥10% (TNBC) | 9 | 22.2 | NA | NA | ||
| PD-L1+IC<10% (TNBC) | 39 | 2.6 | NA | NA | ||
|
NCT01375842
(23) |
Atezolizumab | TNBC | 115 | 10.0 | 1.4 | 8.9 |
| TNBC (first line) vs. TNBC (second line) | 21 vs. 94 | 24.0 vs. 6.0 | 1.6 vs. 1.4 | 17.6 vs. 7.3 | ||
| PD-L1+ (IC≥1%) vs. PD-L1− (IC<1%) | 21 vs. 91 | 0 vs. 11.0 | 1.4 vs. 1.4 | 10.1 vs. 6.0 | ||
| PD-L1+ (IC≥5%) vs. PD-L1− (IC<5%) | 38 vs. 74 | 5.0vs. 12.0 | 1.8 vs. 2.0 | 10.5 vs. 7.0 | ||
| PD-L1+ (IC≥10%) vs. PD-L1− (IC<10%) | 54 vs. 56 | 7.0 vs. 13.0 | NA | 12.6 vs. 6.7 | ||
|
NCT01633970
(33) |
Atezolizumab +
nab-paclitaxel |
TNBC | 33 | 39.4 | 5.5 | 14.7 |
| TNBC (first line) vs. TNBC (≥second line) | 13 vs. 20 | 53.8 vs. 30.0 | 8.6 vs. 5.1 | 24.2 vs. 12.4 | ||
| PD-L1+ (IC≥1%) vs. PD-L1− (IC<1%) | 12 vs. 12 | 41.4 vs. 33.3 | 6.9 vs. 5.1 | 21.9 vs. 11.4 | ||
| IMpassion130
(28)# |
Nab-paclitaxel +
atezolizumab/ placebo |
ITT | 451 vs.451 | 56.0 vs.45.9 | 7.2 vs. 5.5 | 21.3 vs. 17.6 |
| PD-L1+ (PD-L1+IC≥1%) | 185 vs.184 | 58.9vs. 42.6 | 7.5 vs. 5.0 | 25.0 vs. 15.5 | ||
| IMpassion130
(29)## |
Nab-paclitaxel +
atezolizumab/ placebo |
ITT | 451 vs.451 | 56.0 vs. 45.9 | 7.2 vs. 5.5 | 21.0 vs. 18.7 |
| PD-L1+ (PD-L1+IC≥1%) | 185 vs.184 | 58.9 vs. 42.6 | 7.5 vs. 5.0 | 25.0 vs. 18.0 | ||
| IMpassion130
(30)* |
Nab-paclitaxel +
atezolizumab/ placebo |
ITT | 451 vs. 451 | 56.0 vs. 45.9 | 7.2vs. 5.5 | 21.0 vs. 18.7 |
| PD-L1+ (PD-L1+IC≥1%) | 185 vs.184 | 58.9 vs. 42.6 | 7.5 vs. 5.0 | 25.4 vs. 17.9 | ||
| IMpassion130
(32) (Japanese) |
Nab-paclitaxel +
atezolizumab/ placebo |
ITT | 34 vs. 31 | 67.6 vs. 51.6 | 7.4 vs. 4.6 | NA vs. 16.8 |
| PD-L1+ (PD-L1+IC≥1%) | 12 vs. 13 | 75.0 vs. 53.8 | 10.8 vs. 3.8 | NA vs. 13.3 | ||
|
NCT02628132
(35) |
Durvalumab +
weekly paclitaxel |
TNBC | 14 | 35.7 | 5 | 20.7 |
| IMpassion131
(34) |
Paclitaxel +
atezolizumab/ placebo |
ITT | 431 vs. 220 | 43.0 vs. 36.0 | 5.7 vs. 5.6 | 19.2 vs. 22.8 |
| PD-L1+ (PD-L1+IC≥1%) | 191 vs. 101 | 52.0 vs. 44.0 | 6.0 vs. 5.7 | 22.1 vs. 28.3 | ||
| MEDIOLA
(42) |
Durvalumab +
olaparib |
Overall population | 34 | 63.3 | 8.2 | 21.5 |
| TNBC | 17 | 58.5 | 4.9 | 20.5 | ||
| Hormone receptor positive | 13 | 69.2 | 9.9 | 22.4 | ||
| 0−1 prior lines | 20 | 70.0 | 11.7 | 23.4 | ||
| 2 prior lines | 10 | 50.0 | 6.5 | 16.9 | ||
| PD-L1+ TC≥1% vs. <1% | 10 vs. 17 | 80.0vs. 52.9 | 6.7 vs. 8.2 | 23.9 vs. 18.8 | ||
| PD-L1+ IC≥1% vs. <1% | 17 vs. 10 | 64.7 vs. 60.0 | 6.7 vs. 8.2 | 21.5vs. 16.9 | ||
| CD3 TILs≥458/mm² vs. <458/mm² | 13 vs. 13 | 53.8vs. 61.5 | 6.7vs. 8.3 | 19.2vs. 19.2 | ||
| CD8 TILs≥458/mm² vs. <458/mm² | 13 vs. 12 | 61.5vs. 58.3 | 9.9vs. 7.2 | 23.9vs. 18.6 | ||
| BRCA1 mutation | 14 | 64.3 | 4.9 | 19.2 | ||
| BRCA2 mutation | 16 | 62.5 | 9.9 | 21.5 | ||