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EV-201

Enfortumab vedotin in locally advanced or metastatic urothelial carcinoma previously treated with platinum chemotherapy and anti-PD-1/L1 therapy (EV-201)

Phase 2NCT03219333

Population
Locally advanced or metastatic urothelial carcinoma previously treated with PD-1 or PD-L1 inhibitors (cohort 1 also with platinum chemotherapy; cohort 2 cisplatin-ineligible without prior platinum in the advanced setting)
Design
Global, single-arm phase 2 study of enfortumab vedotin 1.25 mg/kg on days 1, 8 and 15 of 28-day cycles; primary endpoint confirmed objective response rate per RECIST 1.1 by blinded independent central review.
Primary endpoint
ORR
Arms
  • Cohort 1: after platinum and PD-1/L1 therapy (experimental, n = 125): Enfortumab vedotin 1.25 mg/kg days 1, 8, 15 of 28-day cycles
  • Cohort 2: cisplatin-ineligible, after PD-1/PD-L1 therapy (experimental, n = 89): Enfortumab vedotin 1.25 mg/kg days 1, 8, 15 of 28-day cycles
People
Rosenberg JE
Show the numbers
Results reported for EV-201
EndpointAnalysisCohort 1: after platinum and PD-1/L1 therapy / Cohort 2: cisplatin-ineligible, after PD-1/PD-L1 therapyControlEffect
ORRCohort 1 (n = 125)primarymedian follow-up 10.2 monthsRosenberg 201944% (35.1–53.2%)—12% complete responses.
DORCohort 1 respondersprimaryRosenberg 2019median 7.6 months—Range 0.95 to 11.30+ months.
ORRCohort 2, treated patients (n = 89)primarymedian follow-up 13.4 monthsYu 202152% (41–62%)—20% of patients had a complete response and 31% a partial response.
Results reported for EV-201
EndpointAnalysisCohort 1: after platinum and PD-1/L1 therapy / Cohort 2: cisplatin-ineligible, after PD-1/PD-L1 therapyControlEffect
ORRCohort 1 (n = 125)primarymedian follow-up 10.2 monthsRosenberg 201944% (35.1–53.2%)—12% complete responses.
DORCohort 1 respondersprimaryRosenberg 2019median 7.6 months—Range 0.95 to 11.30+ months.
ORRCohort 2, treated patients (n = 89)primarymedian follow-up 13.4 monthsYu 202152% (41–62%)—20% of patients had a complete response and 31% a partial response.
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%051015Months (modelled)
  • Cohort 1: after platinum and PD-1/L1 therapy (experimental)

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

Data table (modelled values)
MonthsCohort 1: after platinum and PD-1/L1 therapy
0100.0%
563.4%
1040.2%
1427.9%
1917.7%
Primary publication: Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol. 2019;37(29):2592-2600. PubMedDOI

Appears in

Sources

  1. Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol. 2019;37(29):2592-2600.

    PubMedDOI

  2. Yu EY, Petrylak DP, O'Donnell PH, Lee JL, van der Heijden MS, Loriot Y, et al. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV‑201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021;22(6):872-882.

    PubMedDOI