Seagen, Astellas Pharma report ‘positive’ results from Phase 3 EV-302 trial

Seagen (SGEN) and Astellas Pharma (ALPMY) announced positive topline results from the Phase 3 EV-302 clinical trial for PADCEV in combination with KEYTRUDA versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer, a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body. The EV-302 trial enrolled patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status. The EV-302 study met its dual primary endpoints of overall survival and progression-free survival, compared to chemotherapy. An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. The safety results of the combination are consistent with those of enfortumab vedotin in combination with pembrolizumab previously reported in cisplatin-ineligible patients with la/mUC.