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TROPHY-U-01

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

Phase 2NCT03547973

Population
Metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors (cohort 1)
Design
Multicohort, open-label, phase II registrational study. Cohort 1: locally advanced, unresectable or metastatic urothelial carcinoma progressing after platinum-based chemotherapy and a checkpoint inhibitor; sacituzumab govitecan 10 mg/kg on days 1 and 8 of 21-day cycles. Primary outcome centrally reviewed objective response rate.
Primary endpoint
ORR
Arms
  • Cohort 1: sacituzumab govitecan (experimental, n = 113): Sacituzumab govitecan 10 mg/kg days 1 and 8 of 21-day cycles
People
Tagawa ST
Show the numbers
Results reported for TROPHY-U-01
EndpointAnalysisCohort 1: sacituzumab govitecanControlEffect
ORRCohort 1 (n = 113)Objective response rate by central reviewprimarymedian follow-up 9.1 monthsTagawa 202127% (19.5–36.6%)——
DORCohort 1 respondersprimarymedian follow-up 9.1 monthsTagawa 2021median 7.2 months (4.7–8.6)——
PFSCohort 1 (n = 113)primarymedian follow-up 9.1 monthsTagawa 2021median 5.4 months (3.5–7.2)——
OSCohort 1 (n = 113)primarymedian follow-up 9.1 monthsTagawa 2021median 10.9 months (9.0–13.8)——
Results reported for TROPHY-U-01
EndpointAnalysisCohort 1: sacituzumab govitecanControlEffect
ORRCohort 1 (n = 113)Objective response rate by central reviewprimarymedian follow-up 9.1 monthsTagawa 202127% (19.5–36.6%)——
DORCohort 1 respondersprimarymedian follow-up 9.1 monthsTagawa 2021median 7.2 months (4.7–8.6)——
PFSCohort 1 (n = 113)primarymedian follow-up 9.1 monthsTagawa 2021median 5.4 months (3.5–7.2)——
OSCohort 1 (n = 113)primarymedian follow-up 9.1 monthsTagawa 2021median 10.9 months (9.0–13.8)——
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%051015Months (modelled)
  • Cohort 1: sacituzumab govitecan (experimental)

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

Data table (modelled values)
MonthsCohort 1: sacituzumab govitecan
0100.0%
561.8%
942.0%
1426.0%
1817.7%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%024681012Months (modelled)
  • Cohort 1: sacituzumab govitecan (experimental)

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

Data table (modelled values)
MonthsCohort 1: sacituzumab govitecan
0100.0%
368.0%
740.7%
1027.7%
1416.6%
Primary publication: Tagawa ST, Balar AV, Petrylak DP, Kalebasty AR, Loriot Y, Fléchon A, et al. 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. J Clin Oncol. 2021;39(22):2474-2485. PubMedDOI

Appears in

Sources

  1. Tagawa ST, Balar AV, Petrylak DP, Kalebasty AR, Loriot Y, Fléchon A, et al. 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. J Clin Oncol. 2021;39(22):2474-2485.

    PubMedDOI