What is the role of enfortumab vedotin in the treatment of metastatic breast cancer?

Updated: Feb 23, 2021
  • Author: Kara N Babaian, MD, FACS; Chief Editor: Bradley Fields Schwartz, DO, FACS  more...
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Enfortumab vedotin is an antibody-drug conjugate (ADC) composed of an anti–nectin-4 monoclonal antibody attached to the cell-killing agent, monomethylauristatin E (MMAE). Once the antibody attaches to nectin-4 that is expressed on the tumor, the complex is internalized in the lysosome, which releases MMAE. 

The FDA approved enfortumab vedotin in December 2019 for locally advanced or metastatic urothelial cancer in patients who have received a PD-1/L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting. Approval was based on the single-arm, phase II EV-201 global trial, which enrolled 125 patients with locally advanced or metastatic urothelial cancer who had received prior treatment with a PD-1 or PD-L1 inhibitor and a platinum-based chemotherapy. The primary endpoint of confirmed ORR was 44% per blinded independent central review (55/125; 95% CI, 35.1-53.2). Of patients treated with the single agent enfortumab vedotin, 12% (15/125) experienced a complete response and 32% (40/125) experienced a partial response. [142]

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