Table 3.

Main results of clinical trials testing immune checkpoint inhibitors alone or in combination with chemotherapy in advanced/metastatic triple-negative breast cancer.

Drug(s)	Phase	N	PD-L1 stratified	ORR (%)	Median PFS	Median OS	Trial
Monotherapy
Pembrolizumab	I	32	≥1% TC	18.5	1.9 (1.7–5.5)	11.2 (5.3-NR)	KEYNOTE-012 (NCT01848834)
			Overall	5.3	2.0 (1.9–2.0)	9.0 (7.6–11.2)
Pembrolizumab	II	170	≥1 CPS	5.7	2.0 (1.9–2.1)	8.8 (7.1–11.2)	KEYNOTE-086-A (NCT02447003)
			Negative	4.7	1.9 (1.7–2.0)	9.7 (6.2–12.6)
Pembrolizumab	II	84	≥1 CPS	21.4	2.1 (2.0–2.2)	18.0 (12.9–23.0)	KEYNOTE-086-B (NCT02447003)
			Overall	9.6	2.1 (1.33–1.92)	9.9 (0.82–1.15)
Pembrolizumab	III	622	≥1 CPS	12.3	2.1 (1.08–1.68)	10.7 (0.69–1.06)	KEYNOTE-119 (NCT02555657)
			≥10 CPS	17.7	2.1 (0.82–1.59)	12.7 (0.57–1.06)
			≥20 CPS	26.3	3.4 (0.49–1.18)	14.9 (0.38–0.88)
			Overall	5.2	5.9 (5.7–6.9)	9.2 (4.3–NR)
Avelumab	I	58	≥10% IC	22.2	NA	NA	JAVELIN (NCT01772004)
			<10% IC	2.6	NA	NA
Atezolizumab	I	115	≥1% IC	10	1.4 (1.3–1.6)	8.9 (7.0–12.6)	NCT01375842
Combinations
Pembrolizumab + eribulin	I/II	106	Overall	26.4	4.2 (4.1–5.6)	17.7 (13.7–NR)	ENHANCE-1 (NCT02513472)
			≥1 CPS (1 line)	34.5	6.1 (4.1–10.2)	21.0 (8.3–29.0)
			<1 CPS (1 line)	16.1	3.5 (2.0–4–2)	15.2 (12.8–19.4)
			≥1 CPS (2–3 line)	24.4	4.1 (2.1–4.8)	14.0 (11.0–19.4)
			<1 CPS (2–3 line)	18.2	3.9 (2.3–6–3)	15.5 (12.4-18-7)
Atezolizumab + nabpaclitaxel	I	33	Overall	39.4	9.1 (2.0–20.9)	14.7 (10.1–NR)	NCT01375842
Atezolizumab + nabpaclitaxel	III	902	Overall	56	7.2 (0.69–0.92)	21.0 (0.72–1.02)	IMpassion130 (NCT02425891)
			≥1% IC	58.9	7.5 (0.49–0.78)	25.0 (0.54–0.93)

PFS and OS are expressed as median (95% confidence interval), in months.

PFS progression-free survival OS overall survival, NR not reached, TC tumor cells, CPS combined positive score, IC immune cells, NA not available.