Immunomedics announces phase III ASCENT study of sacituzumab govitecan to treat metastatic triple-negative breast cancer to be stopped for compelling efficacy.

Immunomedics, Inc. has announced that its Phase III confirmatory ASCENT study will be halted due to compelling evidence of efficacy. This decision was based on the unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC), during its recent routine review of the ASCENT study. ASCENT is a Phase III confirmatory study designed to validate the promising safety and efficacy data of sacituzumab govitecan observed in a Phase II study of heavily pretreated patients with metastatic TNBC (mTNBC). The primary endpoint for the study is progression-free survival, and secondary endpoints include overall survival and objective response rate, among others.

A biologics license application resubmission seeking accelerated approval of sacituzumab govitecan for the treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease is currently under FDA review, with a PDUFA target action date of 2 June 2020. The FDA previously granted Breakthrough Therapy Designation for sacituzumab govitecan in this disease setting.