Immunotherapy monotherapy

KEYNOTE-119 (NCT02555657) was a phase III, randomized, open-label, multicenter, international trial that enrolled patients with metastatic TNBC. Patients had received one or two previous systemic treatments for metastatic disease and had previous treatment with an anthracycline or taxane. The trial randomly assigned 622 patients to receive intravenous pembrolizumab 200 mg once every 3 weeks for 35 cycles (pembrolizumab group), or to the investigator's choice of single-drug chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). The primary end point was OS as assessed in each of the following groups: patients with a PD-L1 CPS of 10 or more, patients with a CPS of 1 or more, and all patients.[63]

KEYNOTE-119 (NCT02555657) was a phase III, randomized, open-label, multicenter, international trial that enrolled patients with metastatic TNBC. Patients had received one or two previous systemic treatments for metastatic disease and had previous treatment with an anthracycline or taxane. The trial randomly assigned 622 patients to receive intravenous pembrolizumab 200 mg once every 3 weeks for 35 cycles (pembrolizumab group), or to the investigator's choice of single-drug chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). The primary end point was OS as assessed in each of the following groups: patients with a PD-L1 CPS of 10 or more, patients with a CPS of 1 or more, and all patients.[63]

In patients with a PD-L1 CPS of 10 or more, the median OS was 12.7 months (95% CI, 9.9–16.3) in the pembrolizumab group and 11.6 months (95% CI, 8.3–13.7) in the chemotherapy group (HR, 0.78; 95% CI, 0.57–1.06; log-rank P = .057).[63][Level of evidence A1]

KEYNOTE-119 (NCT02555657) was a phase III, randomized, open-label, multicenter, international trial that enrolled patients with metastatic TNBC. Patients had received one or two previous systemic treatments for metastatic disease and had previous treatment with an anthracycline or taxane. The trial randomly assigned 622 patients to receive intravenous pembrolizumab 200 mg once every 3 weeks for 35 cycles (pembrolizumab group), or to the investigator's choice of single-drug chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). The primary end point was OS as assessed in each of the following groups: patients with a PD-L1 CPS of 10 or more, patients with a CPS of 1 or more, and all patients.[63]

In patients with a CPS of 1 or more, the median OS was 10.7 months (95% CI, 9.3–12.5) in the pembrolizumab group and 10.2 months (95% CI, 7.9–12.6) in the chemotherapy group (HR, 0.86; 95% CI, 0.69–1.06; log-rank P = .073).

KEYNOTE-119 (NCT02555657) was a phase III, randomized, open-label, multicenter, international trial that enrolled patients with metastatic TNBC. Patients had received one or two previous systemic treatments for metastatic disease and had previous treatment with an anthracycline or taxane. The trial randomly assigned 622 patients to receive intravenous pembrolizumab 200 mg once every 3 weeks for 35 cycles (pembrolizumab group), or to the investigator's choice of single-drug chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). The primary end point was OS as assessed in each of the following groups: patients with a PD-L1 CPS of 10 or more, patients with a CPS of 1 or more, and all patients.[63]

Among all patients, the median OS was 9.9 months (95% CI, 8.3–11.4) in the pembrolizumab group and 10.8 months (95% CI, 9.1–12.6) in the chemotherapy group (HR, 0.97; 95% CI, 0.82–1.15).