Sacituzumab govitecan (IMMU-132) had an objective response rate (ORR) of 33% in pretreated patients with triple-negative breast cancer (TNBC), according to updated findings from a phase II study reported by Immunomedics, the manufacturer of the antibody-drug conjugate.
Based on data from the phase II study, sacituzumab govitecan received an FDA breakthrough therapy designation in February 2016 for the treatment of patients with TNBC following at least 2 treatments for metastatic disease. Immunomedics plans to submit an application to the FDA for accelerated approval of sacituzumab govitecan in this setting based on the ongoing phase II trial. The company also plans to launch a confirmatory phase III trial by the end of the 2016, and will publish the phase II study data in a peer-reviewed journal.
1. Bardia A, Diamond R, Mayer A, et al. Safety and efficacy of anti-Trop-2 antibody drug conjugate, sacituzumab govitecan (IMMU-132), in heavily pretreated patients with TNBC. Presented at: the 2015 San Antonio Breast Cancer Symposium; San Antonio, TX; December 8-12, 2015. PD3-06.
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