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Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy


Oct. 14, 2019


A pivotal phase II study of enfortumab vedotin (anti-NECTIN-4) delivered ORR 44%, including 12% CR, in pre-treated patients (platinum, anti-PD-1/L1).

Combination enfortumab vedotin (anti-NECTIN-4) and pembrolizumab showed ORR 62% in platinum ineligible patients in the first line setting; phase Ib trial. Patients were not preselected for PD-L1 or NECTIN-4 expression. ESMO 2019 abstract 901O

Enfortumab vedotin demonstrated a clinically meaningful response rate with a manageable and tolerable safety profile in patients with locally advanced or metastatic urothelial carcinoma who were previously treated with platinum and anti–PD-1/L1 therapies.