The New England Journal of MedicineEnfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer

Enhanced Outcomes with Enfortumab Vedotin and Pembrolizumab in Urothelial Cancer

In a significant phase 3 trial, researchers compared the effectiveness and safety of enfortumab vedotin and pembrolizumab against traditional platinum-based chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma. This study stands out for its direct comparison of innovative immunotherapy and chemotherapy, providing valuable insights into treatment advancements for this challenging cancer type.

Study Design:

• The research was a global, open-label, phase 3, randomized trial.
• Participants included patients with previously untreated locally advanced or metastatic urothelial carcinoma.
• Patients were randomly assigned to receive either enfortumab vedotin and pembrolizumab or platinum-based chemotherapy (gemcitabine with cisplatin or carboplatin).
• Primary endpoints were progression-free survival and overall survival, assessed by a blinded independent central review.

Key Findings:

• The study included 886 patients, with 442 in the enfortumab vedotin–pembrolizumab group and 444 in the chemotherapy group.
• Progression-free survival was notably longer in the enfortumab vedotin–pembrolizumab group (12.5 months) compared to the chemotherapy group (6.3 months).
• Overall survival was also significantly extended in the enfortumab vedotin–pembrolizumab group (31.5 months) versus the chemotherapy group (16.1 months).
• Fewer patients in the enfortumab vedotin–pembrolizumab group experienced grade 3 or higher treatment-related adverse events compared to the chemotherapy group.

HCN Medical Memo
Enfortumab vedotin and pembrolizumab therapy significantly improved outcomes compared to chemotherapy in patients with untreated advanced or metastatic urothelial carcinoma, maintaining a consistent safety profile.

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