TROPHY-U-01
After platinum chemotherapy and checkpoint inhibition, what activity did sacituzumab govitecan show in advanced urothelial carcinoma?
Key reported outcomes
Values are reproduced from the linked sources. Bars are a visual aid and are scaled within each outcome row; do not compare bar lengths across different endpoints.
27%
5.4 months
10.9 months
At median follow-up of 9.1 months, ORR was 27%; median PFS was 5.4 months and median OS 10.9 months. Grade ≥3 treatment-related neutropenia occurred in 35%, leukopenia 18%, anaemia 14% and diarrhoea 10%.
Critical appraisal
Single-arm evidence and historical comparisons are vulnerable to selection bias. The subsequent confirmatory TROPiCS-04 study did not establish the required benefit, and the US accelerated approval for urothelial carcinoma was withdrawn in November 2024.
Absolute-effect discipline: NNT/NNH is not calculated unless a defensible absolute difference and a common time horizon are available. Median survival differences and hazard ratios alone are not converted into NNT.
Current-practice context
Reviewed 2026-10-14; this is a dated evidence-context note, not a substitute for local guidelines or individual clinical judgement.
Historical evidence only for the withdrawn US urothelial indication; do not present sacituzumab govitecan as a currently FDA-approved standard for urothelial carcinoma. Regulatory status differs by jurisdiction and should be checked locally.
Freshness status: this page has a dated context and source links, but is not a claim that every relevant guideline or subsequent publication has been exhaustively reviewed.