Astellas Pharma, and Seattle Genetics recently began dosing the first patient in a registrational, phase two clinical trial of enfortumab vedotin for patients with certain forms of urothelial bladder cancer.
The study, EV-201, is designed to treat patients with locally advanced or metastatic urothelial cancer and who have already been treated with checkpoint inhibitor (CPI) therapy, an Astellas release said. The EV-201 study is being done to support Astellas and Seattle Genetics’ future U.S. Food and Drug Administration (FDA) accelerated approval regulations.
"Locally advanced or metastatic urothelial cancers are often aggressive and treatment-resistant,” Seattle Genetics Chief Medical Officer and Executive Vice President Jonathan Crachman said in the release. “Treatment options are limited for those many patients who do not respond to chemotherapy and checkpoint inhibitors, or CPIs. In addition, there are no FDA-approved therapies for patients who progress following CPI treatment.”
"Initiation of this pivotal phase 2 trial of enfortumab vedotin is a significant advance toward our goal of providing a new treatment option for patients with locally advanced or metastatic urothelial cancer,” Crachman said in the release.