The phase III confirmatory ASCENT study will be halted due to compelling evidence of efficacy, according to Immunomedics, the company leading the study.1
The decision was based on the unanimous recommendation by an independent data safety monitoring committee (DSMC) during its routine review of the ASCENT study.
ASCENT is designed to validate the promising safety and efficacy data of sacituzumab govitecan observed in a phase II study of heavily pretreated patients with metastatic triple-negative breast cancer (mTNBC). The primary endpoint for the study is progression-free survival, and secondary endpoints include overall survival and objective response, among others.
“It is my distinct honor to have served as Chairperson of the independent DSMC for this important study,” Julie R. Gralow, MD, Jill Bennett Endowed Professor of Breast Cancer at the University of Washington…