– Risk of death was reduced by 53% in patients treated with enfortumab vedotin plus pembrolizumab compared to chemotherapy –
– Enfortumab vedotin plus pembrolizumab improved median overall survival by more than 15 months vs. chemotherapy –
– Results will form the basis of global regulatory submissions –
TOKYO and BOTHELL, Wash., Oct. 22, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) for PADCEV® (enfortumab vedotin-ejfv) in combination with KEYTRUDA® (pembrolizumab) versus chemotherapy. The combination improved overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2023 as part of the Presidential Session (Abstract #LBA6).
The EV-302 study met its dual primary endpoints of OS and PFS, compared to platinum and gemcitabine chemotherapy. Patients treated with enfortumab vedotin and pembrolizumab experienced: