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TROPiCS-04

Sacituzumab govitecan versus treatment of physician's choice in advanced urothelial carcinoma after platinum-based chemotherapy and checkpoint inhibitor therapy (TROPiCS-04)

Phase 3N = 711NCT04527991

Population
Advanced urothelial carcinoma that progressed on prior platinum-based chemotherapy and checkpoint inhibitor therapy
Design
Global, open-label, randomised phase 3 trial; 1:1 to sacituzumab govitecan or treatment of physician's choice (paclitaxel, docetaxel or vinflunine). Primary endpoint overall survival; the abstract reports the final analysis.
Primary endpoint
OS
Arms
  • Sacituzumab govitecan (experimental): Sacituzumab govitecan
  • Treatment of physician's choice (control): Paclitaxel, docetaxel or vinflunine
People
Powles T
OSHR 0.86 (95% CI 0.73–1.02)Δ median OS+1.3 monthsPFSHR 0.86 (95% CI 0.72–1.03)Δ median PFS+0.6 monthsΔ ORR+9 points
Show the numbers
Results reported for TROPiCS-04
EndpointAnalysisSacituzumab govitecanTreatment of physician's choiceEffect
OSAll randomised patients (n = 711)finalmedian follow-up 9.2 monthsPowles 2025median 10.3 monthsmedian 9 monthsHR 0.86 (95% CI 0.73–1.02)P=0.087
PFSAll randomised patients (n = 711)finalmedian follow-up 9.2 monthsPowles 2025median 4.2 monthsmedian 3.6 monthsHR 0.86 (95% CI 0.72–1.03)
ORRAll randomised patients (n = 711)finalmedian follow-up 9.2 monthsPowles 202523% (18–27%)14% (10–18%)—
Results reported for TROPiCS-04
EndpointAnalysisSacituzumab govitecanTreatment of physician's choiceEffect
OSAll randomised patients (n = 711)finalmedian follow-up 9.2 monthsPowles 2025median 10.3 monthsmedian 9 monthsHR 0.86 (95% CI 0.73–1.02)P=0.087
PFSAll randomised patients (n = 711)finalmedian follow-up 9.2 monthsPowles 2025median 4.2 monthsmedian 3.6 monthsHR 0.86 (95% CI 0.72–1.03)
ORRAll randomised patients (n = 711)finalmedian follow-up 9.2 monthsPowles 202523% (18–27%)14% (10–18%)—
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.860.73–1.02
PFS0.860.72–1.03
Illustrative — modelled from reported values, not trial data. OS, final.
0%25%50%75%100%0510152025Months (modelled)
  • Sacituzumab govitecan (experimental)
  • Treatment of physician's choice (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSacituzumab govitecanTreatment of physician's choice
0100.0%100.0%
666.8%63.0%
1341.7%36.7%
1927.8%23.1%
2617.4%13.5%
Illustrative — modelled from reported values, not trial data. PFS, final.
0%25%50%75%100%0246810Months (modelled)
  • Sacituzumab govitecan (experimental)
  • Treatment of physician's choice (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSacituzumab govitecanTreatment of physician's choice
0100.0%100.0%
361.0%56.1%
543.8%38.2%
826.7%21.4%
1116.3%12.0%
Primary publication: Powles T, Tagawa S, Vulsteke C, Gross-Goupil M, Park SH, Necchi A, et al. Sacituzumab govitecan in advanced urothelial carcinoma: TROPiCS-04, a phase III randomized trial. Ann Oncol. 2025;36(5):561-571. PubMedDOI

Appears in

Sources

  1. Powles T, Tagawa S, Vulsteke C, Gross-Goupil M, Park SH, Necchi A, et al. Sacituzumab govitecan in advanced urothelial carcinoma: TROPiCS-04, a phase III randomized trial. Ann Oncol. 2025;36(5):561-571.

    PubMedDOI