Sacituzumab govitecan
Sacituzumab govitecan (previously IMMU-132) is an antibody-drug conjugate being investigated as a treatment for cancers such as pancreatic cancers, small-cell lung cancer (SCLC) and triple-negative breast cancer.[1]
It is a conjugate of the humanized anti-Trop-2 monoclonal antibody (hRS7) with SN-38, the active metabolite of irinotecan.[2] Each antibody having on average 6.7 molecules of SN-38 attached.[3]
Clinical
A poster presentation reported some activity in a phase II trial for metastatic gastrointestinal cancers.[4]
Activity has been seen in a phase II trial for metastatic triple-negative breast cancer (TNBC);[5] these results led to designation by the FDA as Breakthrough Therapy, an expedited investigational drug development pathway, in February 2016.[6] It was included in the I-SPY2 adaptive clinical trial for breast cancer and has 'graduated' to the later stage trials.[3]
References
- ↑ FDA Fast Track for TNBC
- ↑ Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. 2015
- 1 2 Novel Agents are Targeting Drivers of TNBC. 2016
- ↑ P-162 Interim Results of IMMU-132 (Sacituzumab Govitecan), an Anti-Trop-2 Antibody-Drug Conjugate (ADC), in Patients (pts) with Metastatic Gastrointestinal (GI) Cancers
- ↑ Immunomedics Reports Complete Responses in Patients With Metastatic Triple-Negative Breast Cancer After Sacituzumab Govitecan Treatment
- ↑ New Therapy Shows Early Promise, Continues to Progress in Triple-Negative Breast Cancer. Feb 2016
External links
- IMMU-132 (Sacituzumab Govitecan) Mentions FDA Orphan drug status, mechanism of action, and clinical trials