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) | ||||
