Longer OS With Enfortumab Vedotin Than Chemo in Advanced Urothelial Carcinoma

By Cecilia Brown - November 10, 2022

Enfortumab vedotin led to longer survival than standard chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma, according to results from a phase 3 trial.

Nobuaki Matsubara, of the National Cancer Center Hospital East in Chiba, Japan, and colleagues conducted the study to “further analyze the efficacy and safety” of enfortumab vedotin, a nectin-4-directed antibody and microtubule inhibitor conjugate, in a Japanese population. The US Food and Drug Administration in 2021 approved enfortumab vedotin for use in cisplatin-ineligible patients who have received at least 1 prior line of therapy.

The subgroup analyses of the open-label EV-301 trial included 86 patients with locally advanced or metastatic urothelial carcinoma. The researchers randomized patients 1:1 to receive enfortumab vedotin 1.25 mg/kg on days 1, 8, and 15 in 28-day cycles (n=36) or a preselected standard chemotherapy—docetaxel or paclitaxel—on day 1 of each 21-day cycle (n=50). The study’s primary end point was overall survival (OS), while secondary end points included progression-free survival (PFS) and overall response rate (ORR).

Patients receiving enfortumab vedotin had a longer median OS (15.18 months) than patients receiving standard chemotherapy (10.55 months; hazard ratio [HR], 0.437; 95% CI, 0.209-0.914). The median PFS was also longer in patients receiving enfortumab vedotin (6.47 months) than in those receiving standard chemotherapy (5.39 months; HR, 0.464; 95% CI, 0.258-0.835). The confirmed ORR was 34.4% in patients receiving enfortumab vedotin, while it was 21.3% in those receiving standard chemotherapy.

Treatment-related adverse events occurred in 97.9% of patients receiving standard chemotherapy and in 91.7% of those receiving enfortumab vedotin, with grade 3 or higher treatment-related adverse events occurring in 75% and 63.9% of patients, respectively.

“This subgroup analysis confirmed that [enfortumab vedotin], with consistent efficacy and safety/tolerability in the EV-301 Japanese subgroup and overall study population, represents an important treatment option for previously treated patients with [locally advanced or metastatic urothelial carcinoma],” the researchers concluded.


Japanese subgroup analysis of EV-301: an open-label, randomized phase 3 study to evaluate enfortumab vedotin versus chemotherapy in subjects with previously treated locally advanced or metastatic urothelial carcinoma.