Seattle Genetics, Astellas, Merck To Evaluate Enfortumab Vedotin Plus KEYTRUDA

(RTTNews) - Seattle Genetics, Inc. (SGEN) and Astellas Pharma Inc. have entered a clinical collaboration agreement with Merck to evaluate the combination of Seattle Genetics' and Astellas' antibody-drug conjugate enfortumab vedotin and Merck's anti-PD-1 therapy, KEYTRUDA, in patients with previously untreated metastatic urothelial cancer. The companies will conduct a global, registrational phase 3 clinical trial to be led by Seattle Genetics. The companies currently plan to initiate the trial in the first half of 2020.

Enfortumab vedotin is currently under review by the FDA for the treatment of adult patients with locally advanced or metastatic urothelial cancer. The PDUFA action date is March 15, 2020.