Sacituzumab govitecan in patients with metastatic breast cancer: pooled safety analysis of data from patients in North America, Europe, and Asia

Abstract

Background: Sacituzumab govitecan (SG) is an antibody-drug conjugate that has significantly improved survival outcomes versus standard of care across multiple studies in patients with previously treated metastatic breast cancer (mBC). Cancer treatment is associated with differing rates of treatment-emergent adverse events (TEAEs) based on patient race/location. We evaluated consistency and manageability of SG safety in mBC across multiple clinical studies and regions in this pooled analysis. Materials and methods: Safety data for patients who received SG treatment (10 mg/kg, days 1 and 8 every 21-day cycle) were pooled from clinical studies in North America/Europe (NA/EU; ASCENT, TROPiCS-02, IMMU-132-01) and Asia (EVER-132-001, EVER-132-002, ASCENT-J02). Results: The analysis included 969 patients (688 NA/EU, 281 Asia). In NA/EU, 74% of patients experienced grade >= 3 TEAEs. TEAEs leading to treatment discontinuation (5%) or death (1%) were uncommon. The most common TEAEs were neutropenia, nausea, and diarrhea. The safety profile was similar for patients in Asia, with 78% experiencing grade >= 3 TEAEs and low rates of TEAEs leading to treatment discontinuation (4%) or death (3%). Neutropenia, anemia, leukopenia, increased aspartate aminotransferase, increased alanine aminotransferase, and hypoalbuminemia were more frequently reported in Asia versus NA/EU; diarrhea and fatigue were more common in NA/EU. Conclusions: The safety profile of SG was manageable and consistent with previous studies, with low rates of TEAEs leading to treatment discontinuation or death; some differences in TEAE rates were observed between NA/EU and Asia. This analysis provides further support for SG as a treatment for mBC across multiple patient subgroups.