Table 2.

Completed studies with immune checkpoint inhibitors in triple-negative breast cancer

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	[20, 61]
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
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+)	[11, 64]

PD-L1⁺ expression in stroma or ≥ 1% of tumor cells by immunohistochemistry

irRECIST immune-related Response Evaluation Criteria In Solid Tumors, ORR objective response rate, OS overall survival, PD-L1 programmed death-ligand 1, PFS progression-free survival, Q2W every 2 weeks, Q3W every 3 weeks, RECIST Response Evaluation Criteria In Solid Tumors, TNBC triple-negative breast cancer