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Seattle Genetics, Astellas Report Positive Results From EV-201 Trial

Seattle Genetics, Inc. (SGEN) and Astellas Pharma Inc. reported positive topline results from the first cohort of patients in a pivotal phase 2 single-arm clinical trial known as EV-201. The cohort is evaluating enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received previous treatment with both platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. The company said the trial results showed a 44 percent objective response rate per blinded independent central review.

The companies plan to submit a Biologics License Application (BLA) to the FDA later in the year based on the results from the EV-201 trial.

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