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TROPHY-U-01 Supports Use of Sacituzumab Govitecan-hziy in Metastatic Urothelial Carcinoma

By: Kayci Reyer
Posted: Friday, May 28, 2021

According to findings from the multicohort TROPHY-U-01 trial presented in the Journal of Clinical Oncology, sacituzumab govitecan-hziy, a TROP-2–directed antibody-drug conjugate, has “notable efficacy” for in pretreated metastatic urothelial carcinoma compared with historical controls. In Cohort 1, Scott T. Tagawa, MD, of Weill Cornell Medicine in New York City, and colleagues evaluated the effects of the treatment, which has shown preliminary anticancer activity in this patient population.

“The results from this study supported accelerated approval of [sacituzumab govitecan] in this population,” concluded the study authors.

Cohort 1 of the phase II trial included 113 patients (78% men) with locally advanced, unresectable, or metastatic urothelial carcinoma who had experienced disease progression while undergoing platinum-based combination chemotherapy and checkpoint inhibitor therapy. Patients received 10 mg/kg of sacituzumab govitecan on days 1 and 8 of 21-day cycles, and the median time to follow-up was 9.1 months. The overall response rate was 27% (n = 31). A total of 77% of patients experienced a reduction in measurable disease, and the median duration of response was 7.2 months. Median progression-free survival was 5.4 months, and median overall survival was 10.9 months.

Overall, 6% of patients discontinued treatment due to treatment-related adverse events. The most common treatment-related adverse events of grade 3 or higher were neutropenia (35%), leukopenia (18%), anemia (14%), diarrhea (10%), and febrile neutropenia (10%). Serious treatment-related adverse events that affected multiple patients included febrile neutropenia (n = 10), diarrhea (n = 4), urinary tract infection (n = 4), sepsis (n = 2), and thrombocytopenia (n = 2).

Additional cohorts of TROPHY-U-01 continue to evaluate the role of this antibody-drug conjugate in this patient population.

Disclosure: For full disclosures of the study authors, visit

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