Sacituzumab govitecan

In a phase I/II trial, 108 women with TNBC who received at least two previous chemotherapy regimens (median, three) were treated with sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of a 21-day cycle.[61][Level of evidence C3]

In a phase I/II trial, 108 women with TNBC who received at least two previous chemotherapy regimens (median, three) were treated with sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of a 21-day cycle.[61][Level of evidence C3]

A response rate of 33.3% (95% CI, 24.6%–43.1%) was observed.

In a phase I/II trial, 108 women with TNBC who received at least two previous chemotherapy regimens (median, three) were treated with sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of a 21-day cycle.[61][Level of evidence C3]

The median duration of response was 7.7 months (95% CI, 4.9–10.8).

In a phase I/II trial, 108 women with TNBC who received at least two previous chemotherapy regimens (median, three) were treated with sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of a 21-day cycle.[61][Level of evidence C3]

The main toxicity was neutropenia, and four deaths occurred during treatment.[61][Level of evidence C3]

In a phase I/II trial, 108 women with TNBC who received at least two previous chemotherapy regimens (median, three) were treated with sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of a 21-day cycle.[61][Level of evidence C3]

The FDA granted accelerated approval to sacituzumab govitecan for patients with metastatic TNBC after at least two previous lines of therapy.

A phase III randomized trial (ASCENT [NCT02574455]) confirmed the efficacy of sacituzumab govitecan in patients with metastatic TNBC that was relapsed or refractory to two or more previous chemotherapy regimens. The trial randomly assigned 468 women without brain metastases to receive either sacituzumab govitecan or the physician's choice of single-agent chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). The primary end point was PFS. All patients had previous taxane exposure. Patients received sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of each 21-day cycle.[62]

A phase III randomized trial (ASCENT [NCT02574455]) confirmed the efficacy of sacituzumab govitecan in patients with metastatic TNBC that was relapsed or refractory to two or more previous chemotherapy regimens. The trial randomly assigned 468 women without brain metastases to receive either sacituzumab govitecan or the physician's choice of single-agent chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). The primary end point was PFS. All patients had previous taxane exposure. Patients received sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of each 21-day cycle.[62]

In the chemotherapy arm, 54% of patients received eribulin, 20% received vinorelbine, 13% received capecitabine, and 12% received gemcitabine.

A phase III randomized trial (ASCENT [NCT02574455]) confirmed the efficacy of sacituzumab govitecan in patients with metastatic TNBC that was relapsed or refractory to two or more previous chemotherapy regimens. The trial randomly assigned 468 women without brain metastases to receive either sacituzumab govitecan or the physician's choice of single-agent chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). The primary end point was PFS. All patients had previous taxane exposure. Patients received sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of each 21-day cycle.[62]

The median PFS was 5.6 months (95% CI, 4.3–6.3; 166 events) in the sacituzumab govitecan arm and 1.7 months (95% CI, 1.5–2.6; 150 events) in the chemotherapy arm (HRdisease progression or death, 0.41; 95% CI, 0.32–0.52; P < .001).[62][Level of evidence A1]

A phase III randomized trial (ASCENT [NCT02574455]) confirmed the efficacy of sacituzumab govitecan in patients with metastatic TNBC that was relapsed or refractory to two or more previous chemotherapy regimens. The trial randomly assigned 468 women without brain metastases to receive either sacituzumab govitecan or the physician's choice of single-agent chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). The primary end point was PFS. All patients had previous taxane exposure. Patients received sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of each 21-day cycle.[62]

The median OS was 12.1 months (95% CI, 10.7–14.0) in the sacituzumab govitecan arm and 6.7 months (95% CI, 5.8–7.7) in the chemotherapy arm (HRdeath, 0.48; 95% CI, 0.38–0.59; P < .001).

A phase III randomized trial (ASCENT [NCT02574455]) confirmed the efficacy of sacituzumab govitecan in patients with metastatic TNBC that was relapsed or refractory to two or more previous chemotherapy regimens. The trial randomly assigned 468 women without brain metastases to receive either sacituzumab govitecan or the physician's choice of single-agent chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). The primary end point was PFS. All patients had previous taxane exposure. Patients received sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of each 21-day cycle.[62]

The overall response rate was 35% in the sacituzumab govitecan arm and 5% in the chemotherapy arm.

A phase III randomized trial (ASCENT [NCT02574455]) confirmed the efficacy of sacituzumab govitecan in patients with metastatic TNBC that was relapsed or refractory to two or more previous chemotherapy regimens. The trial randomly assigned 468 women without brain metastases to receive either sacituzumab govitecan or the physician's choice of single-agent chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). The primary end point was PFS. All patients had previous taxane exposure. Patients received sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of each 21-day cycle.[62]

Key treatment-related adverse events of grade 3 or higher occurred more often in patients who received sacituzumab govitecan than patients who received chemotherapy: neutropenia (51% vs. 33%), leukopenia (10% vs. 5%), diarrhea (10% vs. <1%), anemia (8% vs. 5%), and febrile neutropenia (6% vs. 2%).