Triple-Negative Breast Cancer Transformative Drug Confirms Compelling Efficacy
A New Jersey based biopharmaceutical company in the area of antibody-drug conjugates announced that its Phase 3 confirmatory ASCENT study will be halted due to compelling evidence of efficacy.
The primary endpoint for Immunomedics’s study is progression-free survival, and secondary endpoints include overall survival and objective response rate, among others.
This decision announced on April 6, 2020, was based on the unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC), during its recent routine review of the ASCENT study.
This study is an international, multi-center, open-label, randomized, Phase 3 study in patients with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including a taxane) for their metastatic disease.
Julie R. Gralow, MD, Jill Bennett Endowed Professor of Breast Cancer, University of Washington School of Medicine; Member, Fred Hutchinson Cancer Research Center, said in a press release, “Triple-negative breast cancer (TNBC) 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 potentially major advance in the treatment of this devastating disease that 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.”
ASCENT is a Phase 3 confirmatory study designed to validate the promising safety and efficacy data of sacituzumab govitecan observed in a Phase 2 study of heavily pretreated patients with metastatic TNBC (mTNBC).
Breast cancer is the second most common cancer among women in the United States (some kinds of skin cancer are the most common). Black and white women get breast cancer at about the same rate, but black women die from breast cancer at a higher rate than white women, says the Centers for Disease Control and Prevention (CDC).
In 2016, the CDC confirmed 245,299 new cases of Female Breast Cancer and 41,487 women died of Female Breast Cancer in the USA.
Triple-negative breast cancer is a kind of breast cancer that does not have any of the receptors that are commonly found in breast cancer. mTNBC is an aggressive histological subtype, with a poor prognosis, says the NIH.
Chemotherapy remains standard of care for mTNBC, although no agent has been specifically approved for this breast cancer subtype.
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 U.S. Food and Drug Administration (FDA) review, with a target action date of June 2, 2020.
The FDA previously granted Breakthrough Therapy Designation for sacituzumab govitecan in this disease setting.
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer.
Triple-negative breast cancer news published by Precision Vaccinations.