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EV-301

Enfortumab vedotin versus chemotherapy in previously treated locally advanced or metastatic urothelial carcinoma (EV-301)

Phase 3N = 608NCT03474107

Population
Locally advanced or metastatic urothelial carcinoma previously treated with platinum-containing chemotherapy and with progression during or after a PD-1 or PD-L1 inhibitor
Design
Global, open-label phase 3 trial; 1:1 to enfortumab vedotin 1.25 mg/kg on days 1, 8 and 15 of a 28-day cycle or investigator-chosen docetaxel, paclitaxel or vinflunine on day 1 of a 21-day cycle. Primary endpoint overall survival.
Primary endpoint
OS
Arms
  • Enfortumab vedotin (experimental, n = 301): Enfortumab vedotin 1.25 mg/kg days 1, 8, 15 of a 28-day cycle
  • Investigator-chosen chemotherapy (control, n = 307): Docetaxel, paclitaxel or vinflunine on day 1 of a 21-day cycle
People
Powles T
OSHR 0.70 (95% CI 0.56–0.89)Δ median OS+3.91 monthsPFSHR 0.62 (95% CI 0.51–0.75)Δ median PFS+1.84 months
Show the numbers
Results reported for EV-301
EndpointAnalysisEnfortumab vedotinInvestigator-chosen chemotherapyEffect
OSAll randomised patients (n = 608)interimmedian follow-up 11.1 monthsPowles 2021median 12.88 monthsmedian 8.97 monthsHR 0.70 (95% CI 0.56–0.89)P=0.001Prespecified interim analysis; 301 deaths (134 and 167).
PFSAll randomised patients (n = 608)interimmedian follow-up 11.1 monthsPowles 2021median 5.55 monthsmedian 3.71 monthsHR 0.62 (95% CI 0.51–0.75)P<0.001
Results reported for EV-301
EndpointAnalysisEnfortumab vedotinInvestigator-chosen chemotherapyEffect
OSAll randomised patients (n = 608)interimmedian follow-up 11.1 monthsPowles 2021median 12.88 monthsmedian 8.97 monthsHR 0.70 (95% CI 0.56–0.89)P=0.001Prespecified interim analysis; 301 deaths (134 and 167).
PFSAll randomised patients (n = 608)interimmedian follow-up 11.1 monthsPowles 2021median 5.55 monthsmedian 3.71 monthsHR 0.62 (95% CI 0.51–0.75)P<0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.70.56–0.89
PFS0.620.51–0.75
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%051015202530Months (modelled)
  • Enfortumab vedotin (experimental)
  • Investigator-chosen chemotherapy (control)

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

Data table (modelled values)
MonthsEnfortumab vedotinInvestigator-chosen chemotherapy
0100.0%100.0%
865.0%53.9%
1642.3%29.0%
2427.5%15.7%
3217.9%8.4%
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%024681012Months (modelled)
  • Enfortumab vedotin (experimental)
  • Investigator-chosen chemotherapy (control)

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

Data table (modelled values)
MonthsEnfortumab vedotinInvestigator-chosen chemotherapy
0100.0%100.0%
368.8%57.1%
741.7%27.0%
1028.7%15.4%
1417.4%7.3%
Primary publication: Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Durán I, Lee JL, et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021;384(12):1125-1135. PubMedDOI

Appears in

Sources

  1. Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Durán I, Lee JL, et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021;384(12):1125-1135.

    PubMedDOI