Table 2 Completed studies with immune checkpoint inhibitors in triple-negative breast cancer
From: Recent advances in triple negative breast cancer: the immunotherapy era
Trial | Setting | Drug | Patients | Results | Ref. |
|---|---|---|---|---|---|
Single agent immunotherapy | |||||
 KEYNOTE-012 NCT01848834 | Advanced PD-L1+ TNBC | Pembrolizumab 10 mg/kg Q2W | 27 | ORR, 18.5% Median PFS, 1.9 months Median OS, 11.2 months | [60] |
 KEYNOTE-086 NCT02447003 | Advanced, untreated, any PD-L1 TNBC (cohort A) Advanced, untreated PD-L1+ TNBC (cohort B) | Pembrolizumab 200 mg Q3W | Cohort A: 170 Cohort B: 84 | ORR Cohort A, 4.7% ORR Cohort B, 22.6% Median PFS Cohort A, 2 months Median PFS Cohort B, 2.1 months Median OS Cohort A, 8.9 months Median OS Cohort B, 19.2 months | |
 JAVELIN NCT01772004 | TNBC unselected for PD-L1 (68.8% had PD-L1+ tumors) | Avelumab 10 mg/kg every 2 weeks | 58 | ORR, 5.2% (22.2% in PD-L1+) Median PFS, 1.5 months Median OS, 9.2 months | [62] |
 NCT01375842 | Advanced TNBC unselected for PD-L1 (65.7% had PD-L1+ tumors) | Atezolizumab 15 or 20 mg/kg, or at a 1200-mg flat dose, Q3W | 116 | ORR, 10% (12.7% in PD-L1+) Median PFS, 1.4 months by RECIST Median PFS, 1.9 months by irRECIST Median OS, 8.9 months | [63] |
Combination of immunotherapy and chemotherapy | Â | ||||
 KEYNOTE-150 NCT02513472 | Advanced TNBC unselected for PD-L1 | Eribulin ± pembrolizumab 200 mg Q3W | 107 | ORR, 26.4% (30.6% in PD-L1+) Median PFS, 4.2 months Median OS, 17.7 months | [59] |
 IMpassion130 NCT02425891 | Untreated metastatic TNBC unselected for PD-L1 | Nab-paclitaxel ± atezolizumab 840 mg Q2W | 902 (451 treated with atezolizumab) | ORR, 56% (58.9% in PD-L1+) Median PFS, 7.2 months Median PFS, 7.5 months (PD-L1+) Median OS, 21.3 months Median OS, 25 months (PD-L1+) | |