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. 2022 Jul 14;195(1):1–15. doi: 10.1007/s10549-022-06665-6

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