FRIDAY, March 8, 2024 (HealthDay News) — For patients with previously untreated locally advanced or metastatic urothelial carcinoma, enfortumab vedotin and pembrolizumab yield significantly better survival than chemotherapy, according to a study published in the March 7 issue of the New England Journal of Medicine.

Thomas Powles, M.D., from Queen Mary University of London, and colleagues conducted a phase 3, randomized trial to compare the efficacy and safety of enfortumab vedotin and pembrolizumab with platinum-based chemotherapy among patients with previously untreated locally advanced or metastatic urothelial carcinoma. A total of 886 patients were randomly assigned to receive three-week cycles of enfortumab vedotin and pembrolizumab (442 patients) or gemcitabine and either cisplatin or carboplatin (chemotherapy group; 444 patients).

The median duration of follow-up for survival was 17.2 months as of Aug. 8, 2023. The researchers found that the enfortumab vedotin-pembrolizumab group had significantly longer progression-free survival than the chemotherapy group (median, 12.5 versus 6.3 months; hazard ratio for disease progression or death, 0.45), as well as longer overall survival (median, 31.5 versus 16.1 months; hazard ratio for death, 0.47). Treatment-related adverse events of grade 3 or higher occurred in 55.9 and 69.5 percent of patients in the enfortumab vedotin-pembrolizumab and chemotherapy groups, respectively.

“This trial showed a significant survival benefit of enfortumab vedotin and pembrolizumab as compared with chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma,” the authors write.

The study was funded by Astellas and Seagen, the manufacturers of enfortumab, and Merck, the manufacturer of pembrolizumab.

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