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Durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a phase 1/2 open-label study

Phase 1/2NCT01693562

Population
Locally advanced or metastatic urothelial carcinoma that progressed on, was ineligible for, or declined prior chemotherapy; 95.3% postplatinum
Design
Ongoing open-label phase 1/2 study; durvalumab 10 mg/kg intravenously every 2 weeks for up to 12 months or until progression, starting another anticancer therapy or unacceptable toxicity. Primary endpoints were safety and confirmed objective response rate per RECIST v1.1 by blinded independent central review.
Primary endpoint
ORR
Arms
  • Durvalumab (experimental, n = 191): Durvalumab 10 mg/kg every 2 weeks, up to 12 months
People
Powles T
Show the numbers
Results reported for Durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a phase 1/2 open-label study
EndpointAnalysisDurvalumabControlEffect
ORRAll treated patients (n = 191)interimmedian follow-up 5.78 monthsPowles 201717.8% (12.7–24.0%)—90-day update; 7 complete responses.
OSAll treated patients (n = 191)interimmedian follow-up 5.78 monthsPowles 2017median 18.2 months; 55% at 12 mo—Median OS 95% CI 8.1 months to not estimable; 1-year OS 95% CI 44% to 65%. Median PFS 1.5 months (95% CI 1.4 to 1.9).
Results reported for Durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a phase 1/2 open-label study
EndpointAnalysisDurvalumabControlEffect
ORRAll treated patients (n = 191)interimmedian follow-up 5.78 monthsPowles 201717.8% (12.7–24.0%)—90-day update; 7 complete responses.
OSAll treated patients (n = 191)interimmedian follow-up 5.78 monthsPowles 2017median 18.2 months; 55% at 12 mo—Median OS 95% CI 8.1 months to not estimable; 1-year OS 95% CI 44% to 65%. Median PFS 1.5 months (95% CI 1.4 to 1.9).
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%010203040Months (modelled)
  • Durvalumab (experimental)

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

Data table (modelled values)
MonthsDurvalumab
0100.0%
1165.8%
2341.6%
3427.4%
4617.3%
Primary publication: Powles T, O'Donnell PH, Massard C, Arkenau HT, Friedlander TW, Hoimes CJ, et al. Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study. JAMA Oncol. 2017;3(9):e172411. PubMedDOI

Appears in

Sources

  1. Powles T, O'Donnell PH, Massard C, Arkenau HT, Friedlander TW, Hoimes CJ, et al. Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study. JAMA Oncol. 2017;3(9):e172411.

    PubMedDOI