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Seattle Genetics, Astellas Say Phase 3 Trial Of PADCEV Meets Primary Endpoint - Quick Facts

(RTTNews) - Biotechnology company Seattle Genetics, Inc. (SGEN) and Japanese pharmaceutical company Astellas Pharma Inc. (ALPMY, ALPMY) announced Friday that a phase 3 trial of PADCEV (enfortumab vedotin-ejfv) met its primary endpoint of overall survival compared to chemotherapy.

The results were reviewed by an independent Data Monitoring Committee following a planned interim analysis. The trial stopped early due to positive results at planned interim analysis.

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.

In the trial, PADCEV significantly improved overall survival (OS), with a 30 percent reduction in risk of death. PADCEV also significantly improved progression-free survival (PFS), a secondary endpoint, with a 39 percent reduction in risk of disease progression or death.

The global EV-301 clinical trial compared PADCEV to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.

The EV-301 trial is a global, multicenter, open-label, randomized phase 3 trial designed to evaluate PADCEV versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in approximately 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1 or PD-L1 inhibitor and platinum-based therapies.

The results will be submitted to the U.S. Food and Drug Administration (FDA) as the confirmatory trial following the drug's accelerated approval in 2019. EV-301 is also intended to support global registrations.

Seattle Genetics and Astellas are co-developing PADCEV under a 50:50 worldwide development and commercialization collaboration that was entered into in 2007 and expanded in 2009.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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