The phase III confirmatory ASCENT 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 triple negative breast cancer—will be halted due to compelling evidence of efficacy.
The primary endpoint for the study is progression-free survival, and secondary endpoints include overall survival and objective response rate, among others. This decision was based on the unanimous recommendation by the independent data safety monitoring committee during its recent routine review of the ASCENT study.
Immunomedics Inc. sponsors the trial.
“The remarkable results we observed across multiple endpoints in the ASCENT study warranted early discontinuation of the trial and are indicative of a potential major advance in the treatment of this devastating disease that affects younger women and African American women at higher rates,” Julie R. Gralow, Jill Bennett Endowed Professor of Breast Cancer, University of Washington School of Medicine and member of Fred Hutchinson Cancer Research Center, said in a statement.
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 under FDA review, with a PDUFA target action date of June 2, 2020. The FDA previously granted Breakthrough Therapy Designation for sacituzumab govitecan in this disease setting.
