Enfortumab vedotin showed strong clinical activity in patients with locally advanced or metastatic urothelial carcinoma who previously received both platinum-containing chemotherapy and immune checkpoint therapy, according to topline results from the pivotal phase II EV-201 trial announced by Seattle Genetics and Astellas, the manufacturers of the antibody-drug conjugate (ADC).
Grade ≥3 AEs in the RP2D cohort included urinary tract infection (8%), hypophosphatemia (3%), hyponatremia (5%), anemia (8%), and hyperuricemia (5%). Across all treatment doses, there were 3 patient deaths (cardiac arrest, small intestinal perforation and sepsis, and acute renal failure), none of which was considered to be related to enfortumab vedotin.
- Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer. Seattle Genetics. Published March 28, 2019. Accessed March 28, 2019. https://bit.ly/2OuyERy.
- Petrylak DP, Perez RP, Zhang J, et al. A phase I study of enfortumab vedotin: updated analysis of patients with metastatic urothelial cancer. J Clin Oncol 35, 2017 (suppl; abstr 106).
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