Sacituzumab govetecan also known as IMMU-132 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with triple-negative breast cancer (TNBC).
Triple-Negative Breast Cancer includes about 15% of all breast cancer types and has an annual incidence estimated to be about 40,000 people, with 20,000 diagnosed with metastatic TNBC, in the United States alone. As the name implies, Triple-Negative Breast Cancer does not express estrogen, progesterone or the HER2 receptor, and is, therefore, insensitive to most of the available targeted therapies for breast cancer treatment, including HER2-directed therapy.
TNBC has a particularly aggressive course and currently there is no single standard chemotherapy to treat patients with relapsed/refractory metastatic TNBC. New treatment strategies are needed.
Researchers recently reported the results of an early-phase clinical trial to evaluate the safety and effectiveness of treatment with the antibody drug conjugate sacituzumab govetecan (IMMU-132) in heavily pretreated individuals with advanced TNBC. Sacituzumab govitecan targets Trop-2, a calcium signal transducer that drives cancer cell growth in a majority of TNBC patients. IMMU-132 delivers high doses of SN-38, the active metabolite of Irinotecan that is 1000 times more active than Irinotecan itself.
In this early study IMMU-132 was well tolerated and produced an overall response rate of 30% in patients that had failed an average of 5 previous therapies. Additionally, 45% of patients had stable disease (SD), with 16% of the responses lasting for greater than 6 months.
Reference: Bardia A, Diamond JR, Mayer IA, et al. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate (ADC) for the treatment of relapsed/refractory, metastatic triple-negative breast cancer (mTNBC): Updated results. Presented at: 2016 San Antonio Breast Cancer
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