Key bladder cancer data pave way for Seattle Genetics to submit marketing application for armed antibody
Seattle Genetics is one step closer to getting its second armed antibody across the finish line, after the ‘breakthrough’ Astellas-partnered drug — enfortumab vedotin — helped patients with advanced or metastatic urothelial cancer, whose disease progressed despite treatment with both platinum-containing chemotherapy and a checkpoint inhibitor, in a key study.
The drug induced a 44% objective response rate (ORR) in 128 patients — and although detailed results from the single-arm EV-201 study will be revealed at a later date, the data are compelling enough for Seattle to submit a US marketing application for the antibody drug conjugate (ADC), the company said on Thursday. A late-stage trial designed to confirm the drug’s safety and efficacy in this patient population is ongoing.
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