Updated results from phase 1b/II (EV-103) trial of Padcev with pembrolizumab for first-line treatment for advanced urothelial cancer. Seattle Genetics + Astellas
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Bristol Myers Squibb announced the Phase III CheckMate -901 trial, comparing Opdivo (nivolumab) plus Yervoy (ipilimumab) to standard-of-care chemotherapy as a first-line treatment for patients with untreated unresectable or metastatic urothelial carcinoma, did not meet the primary endpoint of overall survival (OS) in patients whose tumor cells express PD-L1 greater than 1% at final analysis.
After meeting with the FDA, Sesen Bio Inc., plans to conduct an additional Phase III clinical trial for Vicineum for the treatment of NMIBC (non-muscle invasive bladder cancer) in connection with the potential resubmission of a BLA.
Astellas Pharma Inc. and Seagen Inc.announced that the European Commission (EC) has approved Padcev (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor.