Seattle Genetics, Astellas ADC heading for bladder cancer submission

Seattle Genetics and Astellas plan to seek accelerated approval of antibody-drug conjugate enfortumab vedotin based on data from the pivotal Phase II EV-201 trial to treat bladder cancer.

Interim results showed that among 128 patients in the trial's first cohort who had received both chemotherapy and a PD-1 or PD-L1 inhibitor, enfortumab vedotin led to an objective response rate (ORR) of 44%. Data from a Phase I trial presented at the 2018 American Society of Clinical Oncology (ASCO) meeting showed that the ADC led to an ORR of 41% in all evaluable patients, and 40% in those who received prior checkpoint inhibitor therapy...