Longer OS With Enfortumab Vedotin Than Chemo in Advanced Urothelial Carcinoma

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.

Reference

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.