Efficacy of enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer

A recent study found that treatment involving enfortumab vedotin and pembrolizumab produced significantly better outcomes than chemotherapy for patients with untreated locally advanced or metastatic urothelial carcinoma. The results of this study were published in the New England Journal of Medicine.

In this randomized, global, open-label phase 3 trial, a total of 886 patients were assigned in a 1:1 ratio to receive 3-week cycles of enfortumab vedotin (administered intravenously at a dose of 1.25 mg per kilogram of body weight on days 1 and 8) and pembrolizumab (administered intravenously at a dose of 200 mg on day 1) in the enfortumab vedotin-pembrolizumab group (N=442), or gemcitabine and either cisplatin or carboplatin in the chemotherapy group (N=444). Progression-free survival and overall survival were the primary endpoints of the study.

The enfortumab vedotin-pembrolizumab group exhibited a longer progression-free survival compared to the chemotherapy group, with a median of 12.5 months versus 6.3 months, respectively. Similarly, the overall survival was also prolonged in the enfortumab vedotin-pembrolizumab group, with a median of 31.5 months compared to 16.1 months in the chemotherapy group. In terms of treatment cycles, the enfortumab vedotin-pembrolizumab group had a median of 12 cycles (range, 1-46), while the chemotherapy group had a median of 6 cycles (range, 1-6). Notably, treatment-related adverse events of grade 3 or higher were observed in 55.9% of patients in the enfortumab vedotin-pembrolizumab group and in 69.5% of patients in the chemotherapy group.

Based on the above results, it can be concluded that treatment with enfortumab vedotin and pembrolizumab in patients with untreated locally advanced or metastatic urothelial carcinoma resulted in improved outcomes compared to chemotherapy.