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UROLOGICAL CANCER

Benefit with enfortumab vedotin confirmed

Nature Reviews Clinical Oncology volume 18, page 258 (2021)Cite this article

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In December 2019, the FDA granted accelerated approval to the nectin-4-targeted antibody–drug conjugate (ADC) enfortumab vedotin for patients with previously treated advanced-stage urothelial carcinoma based on data from a single-arm study. Now, a phase III trial has revealed that enfortumab vedotin is associated with improved overall survival (OS) in these patients.

In this trial, 608 patients who previously received an anti-PD-1/PD-L1 antibody and a platinum-containing regimen were randomly assigned (1:1) to receive enfortumab vedotin or physician’s choice of chemotherapy. Median OS and progression-free survival were longer with the ADC: 12.9 versus 9.0 months (HR 0.70, 95% CI 0.56–0.89; P = 0.001) and 5.6 versus 3.7 months (HR 0.62, 95% CI 0.51–0.75; P < 0.001), respectively. Overall response rate (ORR) and complete response rate were also higher with the ADC: 40.6% and 4.9%, respectively, versus 17.9% and 2.7% (P < 0.001). Of note, the ORR and complete response rate that led to the accelerated approval of enfortumab vedotin were 44% and 12%, respectively.

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  1. Nature Reviews Clinical Oncology http://www.nature.com/nrclinonc

    Diana Romero

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  1. Diana Romero
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Correspondence to Diana Romero.

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Romero, D. Benefit with enfortumab vedotin confirmed. Nat Rev Clin Oncol 18, 258 (2021). https://doi.org/10.1038/s41571-021-00493-1

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