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Sacituzumab Govitecan Succeeds in Phase III TNBC Trial, as FDA Weighs Approval

Jason M. Broderick @jasoncology
Published: Monday, Apr 06, 2020

Julie R. Gralow, MD, clinical director of Breast Medical Oncology at Seattle Cancer Care Alliance and professor of Medical Oncology at University of Washington School of Medicine

Julie R. Gralow, MD

The confirmatory phase III ASCENT study exploring sacituzumab govitecan in patients with metastatic triple-negative breast cancer (TNBC) has been stopped due to “compelling evidence of efficacy,” according to a statement from the company developing the antibody-drug conjugate (ADC), Immunomedics.1

The BLA for sacituzumab govitecan was based on findings from a phase I/II study, which included 108 patients with TNBC at a median age of 55 years (range, 31-80). The majority of patients had visceral metastases (80%). Sacituzumab govitecan was administered at 10 mg/kg on days 1 and 8 of each 28-day cycle. Patients’ ECOG performance status was 0 (30%) and 1 (70%), and the median time from metastatic diagnosis to treatment in the study was 1.5 years. Overall, 57 patients had moderate (2+) to strong (3+) TROP-2 expression by immunohistochemistry and 5 had weak or absent staining for the marker. The data were not available for the remaining patients.

The median number of prior regimens was 3 (range, 2-10), which include checkpoint inhibitors for 16.7%. Additionally, 41% of patients were treated in the third-line setting and 59% were in the fourth-line or greater setting. The most common prior therapies were taxanes (98%), anthracyclines (86%), cyclophosphamide (85%), and platinum agents (75%).

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