The phase III confirmatory ASCENT study of the antibody drug-conjugate sacituzumab govitecan will be stopped based on efficacy across multiple study endpoints following unanimous recommendation from the independent data safety monitoring committee, according to a news release issued earlier this month by Immunomedics, the manufacturer of the study drug.
The ASCENT study is designed to validate safety and efficacy data observed in a phase II study of heavily pretreated patients with metastatic triple-negative breast cancer. The primary endpoint for the study is progression-free survival, and secondary endpoints include overall survival and objective response rate.
During a recent routine review of the trial, the independent data safety monitoring committee decided the study would be halted due to compelling evidence of efficacy.
‘Potential Major Advance’
Julie R. Gralow, MD, FACP, FASCO
Julie R. Gralow, MD, FACP, FASCO, Chairperson of the independent data safety monitoring committee for the study, said “Triple-negative breast cancer is a disease with extremely limited treatment options beyond classic chemotherapy. 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, which affects younger women and African American women at higher rates. I look forward to the release of the full and final analyses of these study data when they are available for public presentation.” Dr. Gralow is the Jill Bennett Endowed Professor of Breast Cancer at the University of Washington School of Medicine and a member of the Fred Hutchinson Cancer Research Center.
A biologics license application resubmission seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease is currently under U.S. Food and Drug Administration (FDA) review. The FDA previously granted Breakthrough Therapy designation for sacituzumab govitecan in this disease setting.
