13 July 2018 - - Bothell, Washington-based cancer treatment developer Seattle Genetics, Inc. (NASDAQ: SGEN) and Tokyo, Japan-based pharmaceutical company Astellas Pharma Inc. have completed enrollment for the enfortumab vedotin EV-201 phase 2 clinical trial second cohort and have started dosing in the phase 3 EV-301 trial, the companies said.
EV-201 is an ongoing single-arm, single-agent phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a checkpoint inhibitor.
The first cohort, 120 patients at multiple centers, includes those who had also been treated with a platinum chemotherapy and the second cohort, currently enrolling, includes those who were cisplatin ineligible/platinum naïve. The primary endpoint is confirmed objective response rate, per independent review.
Seattle Genetics said the EV-301 trial is a global, randomized phase 3 clinical trial evaluating enfortumab vedotin versus physician's choice of chemotherapy in approximately 550 patients with previously treated locally advanced or metastatic urothelial cancer.
The EV-301 trial is intended to support a broader global registration strategy and to serve as the confirmatory randomized trial in the US for EV-201.
Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics' proprietary, linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumors.
Seattle Genetics develops and commercializes novel antibody-based therapies for the treatment of cancer. The company's antibody-drug conjugate technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells.
Astellas Pharma is dedicated to providing innovative and reliable pharmaceutical products with urology, oncology, immunology, nephrology, and neuroscience as prioritized therapeutic areas, while advancing new therapeutic areas and discovery research leveraging new technologies/modalities.