logo
Plus   Neg
Share
Email

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

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
NASA's Osiris-Rex robotic spacecraft briefly touched down on near-Earth asteroid Bennu's surface on Tuesday to collect rock and dust samples that will be brought back to Earth in 2023. Bennu is currently more than 200 million miles, or 321 million kilometres, from Earth. Osiris-Rex launched from Cape Canaveral Air Force Station in Florida in September 2016. Amazon said Wednesday that free one-hour grocery pickup is now available to prime members at all U.S. Whole Foods Market locations. Previously, the prime members could pick up Whole Foods orders only at select stores. J.C. Penney said it is near to exiting Chapter 11 ahead of the busy December 2020 holiday season. The beleaguered retailer filed a draft asset purchase agreement towards finalization of the acquisition by Brookfield Asset Management, Inc. and Simon Property Group, Inc. They are expected to buy substantially all of J.C. Penney's retail and operating assets in a combination of cash and debt.
Follow RTT