Multinational phase 3 trial of first-line sacituzumab govitecan for advanced triple-negative breast cancer

Patients with previously untreated, locally advanced unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibition have limited treatment options. The multinational phase 3 ASCENT-03 trial evaluated the antibody-drug conjugate sacituzumab govitecan (SG) for these patients. Patients were randomized 1:1 to SG or chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin). The median progression-free survival was significantly longer with SG than with chemotherapy. Adverse events of grade 3 or higher occurred in 66% of the patients in the SG group and 62% of the patients in the chemotherapy group, and the incidence of adverse events that led to discontinuation of SG or at least one chemotherapy drug was 4% and 12%, respectively. The authors conclude that SG led to significantly longer PFS than chemotherapy among patients with advanced TNBC who were not candidates for treatment with PD-1 or PD-L1 inhibitors.