TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors.

56 The phase III confirmatory ASCENT trial that compared SG with chemotherapy of physician's choice in triple-negative breast cancer reported a highly significant benefit for SG in all end points including ORR (35% v 5%), PFS (5.6 v 1.7 months), and OS (12.1 v 6.7 months). 57 The clinically meaningful activity and safety profile of SG demonstrated in cohort 1 of the TROPHY-U-01 mUC trial led to the accelerated FDA approval of SG 58 for patients with locally advanced or mUC who previously received a platinum-containing chemotherapy and either a programmed death-1 or a programmed death-ligand 1 inhibitor.

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