Outcomes for trials involving the use of antibody-drug conjugates

Clinical trial identification/referenceClinical settingTreatment settingOutcome(s)
CT02091999/Rosenberg et al. [41]Patients with Nectin-4-expressing solid tumors who progressed on ≥ 1 prior chemotherapy regimen and/or programmed death-1 (PD1) receptor/programmed death ligand-1 (PDL-1) inhibitor, including a cohort of patients with metastatic urothelial carcinoma who received prior anti-PD-L1 therapy.Patients received escalating doses of enfortumab vedotin up to 1.25 mg/kg on days 1, 8, and 15 of every 28-day cycle.Median overall survival was 12.3 months, and the overall survival rate at 1 year was 51.8%.
NCT03219333/Yu et al. [42]Patients with locally advanced or metastatic urothelial carcinoma previously treated with PD-1 or PD-L1 inhibitors. Cohort 2 included adults (aged ≥ 18 years) with an Eastern Cooperative Oncology Group performance status score of 2 or less who were considered ineligible for cisplatin at enrolment and who had not received platinum-containing chemotherapy in the locally advanced or metastatic setting.Enfortumab vedotin was given intravenously at a dose of 1.25 mg/kg on days 1, 8, and 15 of every 28-day cycle.Objective response rate was 52% with 18 of 89 patients achieving a complete response and 31% of patients achieving a partial response.
NCT03474107/Rosenberg et al. [43]Patients with locally advanced or metastatic urothelial carcinoma who had received prior platinum-containing chemotherapy and had disease progression during or after PD-1/L1 inhibitor treatment.Patients randomized to enfortumab vedotin received doses of 1.25 mg/kg (maximum weight, 100 kg) on days 1, 8, and 15 of each 28-day cycle and those randomized to chemotherapy received docetaxel 75 mg/m2, paclitaxel 175 mg/m2, or vinflunine 320 mg/m2 (capped at 35% of patients) on day 1 of each 21-day cycle.Risk of death was reduced by 30% with enfortumab vedotin versus chemotherapy. Median overall survival estimates were 12.91 months and 8.94 months for enfortumab vedotin and chemotherapy, respectively.
NCT03547973/Tagawa et al. [44]Patients with locally advanced or unresectable or metastatic urothelial carcinoma who had progressed after prior platinum-based combination chemotherapy and checkpoint inhibitors.Patients received sacituzumab govitecan 10 mg/kg on days 1 and 8 of 21-day cycles.At a median follow-up of 9.1 months, the objective response rate was 27%; 77% had a decrease in measurable disease. The median duration of response was 7.2, with median progression-free survival and overall survival of 5.4 months and 10.9 months, respectively.