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April 22, 2021 VOL. 384 NO. 16 1529-1541

Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer

By Aditya Bardia
From Massachusetts General Hospital Cancer Center, Boston.

Patients with metastatic triple-negative breast cancer have a poor prognosis. Sacituzumab govitecan is an antibody−drug conjugate composed of an antibody targeting the human trophoblast cell-surface antigen 2 (Trop-2), which is expressed in the majority of breast cancers, coupled to SN-38 (topoisomerase I inhibitor) through a proprietary hydrolyzable linker. This randomized, phase 3 trial evaluated sacituzumab govitecan as compared with single-agent chemotherapy of the physician's choice in 468 patients with relapsed or refractory metastatic triple-negative breast cancer. The median progression-free survival was 5.6 months with sacituzumab govitecan and 1.7 months with chemotherapy. The median overall survival was 12.1 months with sacituzumab govitecan and 6.7 months with chemotherapy. The percentage of patients with an objective response was 35% with sacituzumab govitecan and 5% with chemotherapy. The incidences of key treatment-related adverse events of grade 3 or higher were neutropenia (51% with sacituzumab govitecan and 33% with chemotherapy), leukopenia (10% and 5%), diarrhea (10% and <1%), anemia (8% and 5%), and febrile neutropenia (6% and 2%). There were three deaths owing to adverse events in each group; no deaths were considered to be related to sacituzumab govitecan treatment. Progression-free and overall survival were significantly longer with sacituzumab govitecan than with single-agent chemotherapy among patients with metastatic triple-negative breast cancer. Myelosuppression and diarrhea were more frequent with sacituzumab govitecan.

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