Sacituzumab govitecan

The global phase III TROPiCS-02 trial (NCT03901339) randomly assigned 543 patients to receive either sacituzumab govitecan or physician’s choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). Patients had locally recurrent inoperable or metastatic breast cancer that was endocrine-resistant, chemotherapy-treated, hormone receptor–positive, and HER2-negative. Patients had received three median lines of chemotherapy for advanced disease, and 99% of patients had previously received a CDK4/6 inhibitor. The primary end point was PFS by blinded independent central review.[52][Level of evidence B1]

The global phase III TROPiCS-02 trial (NCT03901339) randomly assigned 543 patients to receive either sacituzumab govitecan or physician’s choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). Patients had locally recurrent inoperable or metastatic breast cancer that was endocrine-resistant, chemotherapy-treated, hormone receptor–positive, and HER2-negative. Patients had received three median lines of chemotherapy for advanced disease, and 99% of patients had previously received a CDK4/6 inhibitor. The primary end point was PFS by blinded independent central review.[52][Level of evidence B1]

An analysis noted a 34% reduction in the risk of progression or death (HR, 0.66; 95% CI, 0.53–0.83; P = .0003). The median PFS was 5.5 months in the sacituzumab govitecan group and 4.0 months in the chemotherapy group. The PFS at 6 and 12 months was 46% and 21% for patients who received sacituzumab govitecan and 30% and 7% for patients who received chemotherapy.

The global phase III TROPiCS-02 trial (NCT03901339) randomly assigned 543 patients to receive either sacituzumab govitecan or physician’s choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). Patients had locally recurrent inoperable or metastatic breast cancer that was endocrine-resistant, chemotherapy-treated, hormone receptor–positive, and HER2-negative. Patients had received three median lines of chemotherapy for advanced disease, and 99% of patients had previously received a CDK4/6 inhibitor. The primary end point was PFS by blinded independent central review.[52][Level of evidence B1]

Median OS data are not mature.

The global phase III TROPiCS-02 trial (NCT03901339) randomly assigned 543 patients to receive either sacituzumab govitecan or physician’s choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). Patients had locally recurrent inoperable or metastatic breast cancer that was endocrine-resistant, chemotherapy-treated, hormone receptor–positive, and HER2-negative. Patients had received three median lines of chemotherapy for advanced disease, and 99% of patients had previously received a CDK4/6 inhibitor. The primary end point was PFS by blinded independent central review.[52][Level of evidence B1]

Key grade 3 or higher treatment-related adverse events were neutropenia (occurring in 51% of patients who received sacituzumab govitecan and 38% of patients who received chemotherapy) and diarrhea (occurring in 9% of patients who received sacituzumab govitecan and 1% of patients who received chemotherapy). One patient in the sacituzumab govitecan group died of a treatment-related adverse event (septic shock related to neutropenic colitis).

The global phase III TROPiCS-02 trial (NCT03901339) randomly assigned 543 patients to receive either sacituzumab govitecan or physician’s choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine). Patients had locally recurrent inoperable or metastatic breast cancer that was endocrine-resistant, chemotherapy-treated, hormone receptor–positive, and HER2-negative. Patients had received three median lines of chemotherapy for advanced disease, and 99% of patients had previously received a CDK4/6 inhibitor. The primary end point was PFS by blinded independent central review.[52][Level of evidence B1]

The objective response rate by blinded independent central review was 21% in the sacituzumab govitecan group and 14% in the chemotherapy group. The clinical benefit rate was higher with sacituzumab govitecan than with chemotherapy (34% vs. 22%).