Table 1.
Non-randomized clinical trials of immune checkpoint blockade with or without chemotherapy in metastatic TNBC
Trial | Key inclusion | Treatment | Subgroups | Sample size | ORR (%) | DCR (%) | Median DOR (months) | Median PFS (months) | Median OS (months) |
---|---|---|---|---|---|---|---|---|---|
NCT01772004a | Any line | Avelumab | 58 | 5.2 | 31 | NR | 5.9 | 9.2 | |
JAVELIN Solid Tumor | |||||||||
NCT01375842 | Any line | Atezolizumab | 115 | 10 | 13 | 21.0 | 1.4 | 8.9 | |
PD-L1 IC ≥ 1% | 91 | 12 | 15 | 21.0 | 1.4 | 10.1 | |||
PD-L1 IC < 1 % | 21 | 0 | 5 | N/A | 1.4 | 6.0 | |||
NCT01848834 | Any line | Pembrolizumab | 32 | 18.5 | 25.9 | NR | 1.9 | 11.2 | |
PD-L1 IC/TC | |||||||||
≥ 1% | |||||||||
KEYNOTE-012 | |||||||||
NCT02447003 | ≥ 2nd line | Pembrolizumab | 170 | 5.3 | 7.6 | NR | 2.0 | 9.0 | |
KEYNOTE-086 | |||||||||
Cohort A | |||||||||
PD-L1 CPS ≥ 1 | 105 | 5.7 | 9.5 | NR | 2.0 | 8.8 | |||
PD-L1 CPS < 1 | 64 | 4.7 | 4.7 | 4.4 | 1.9 | 9.7 | |||
NCT02447003 | 1st line | Pembrolizumab | 84 | 21.4 | 23.8 | 10.4 | 2.1 | 18.0 | |
PD-L1 CPS ≥ 1 | |||||||||
KEYNOTE-086 | |||||||||
Cohort B | |||||||||
NCT01633970 | Any line | Atezolizumab + | 33 | 39.4 | 51.5 | 9.1 | 5.5 | 14.7 | |
Nab-paclitaxel | |||||||||
PD-L1 IC ≥ 1% | 12 | 41.7 | 91.7 | 9.1 | 6.9 | 21.9 | |||
PD-L1 IC < 1% | 12 | 33.3 | 75.0 | 10.2 | 5.1 | 11.4 | |||
NCT02513472 | 1st line | Pembrolizumab + eribulin | PD-L1 CPS ≥ 1 | 29 | 34.5 | NA | 8.3 | 6.1 | 21.0 |
KEYNOTE-150 | |||||||||
PD-L1 CPS < 1 | 31 | 16.1 | 15.2 | 3.5 | 15.2 | ||||
2nd or 3rd line | PD-L1 CPS ≥ 1 | 45 | 24.4 | NA | 8.2 | 4.1 | 14.0 | ||
PD-L1 CPS < 1 | 44 | 18.2 | 8.6 | 3.9 | 15.5 | ||||
NCT03044730a | Any line | Pembrolizumab + capecitabine | 15 | 13 | 60 | NA | 4.0 | 15.3 | |
NCT03121352 | 1st or 2nd line | Pembrolizumab + carboplatin + | 30 | 52 | 77.8 | NA | 6.1 | 11.5 | |
Nab-paclitaxel |
ORR overall response rate, DCR disease control rate, DOR duration of response, PFS progression-free survival, OS overall survival, PD-L1 programmed death-ligand 1, IC immune cell, TC tumor cell, CPS combined positive score, NR not reached, NA not available
aData from the TNBC subgroup of included patients is listed