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Enfortumab Vedotin Impresses In Urothelial Cancer After Chemo, Immunotherapies

 
• By John Davis

The antibody-drug conjugate being evaluated by Astellas and Seattle Genetics has posted “remarkable” positive top-line results in locally advanced or metastatic urothelial cancer, with a US BLA submission expected later in 2019.  

Goalpost
The goal of a better therapy for urothelial cancer may be within reach. • Source: Shutterstock

Right on cue, Seattle Genetics Inc. and Astellas Pharma Inc. have announced positive top-line results from a pivotal Phase II study of the antibody-drug conjugate (ADC), enfortumab vedotin, in locally advanced or metastatic urothelial cancer, and the partners are on track to submit a US BLA for the antibody-drug conjugate, under the FDA’s accelerated approval pathway, later this year.

In the single-arm trial conducted by Astellas and Seattle Genetics, known as EV-201, there was a 44% objective response rate (ORR) to enfortumab vedotin in the first cohort of patients with locally advanced or metastatic urothelial cancer who had previously received

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