TOKYO - 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 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: Median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months (95% CI: 13.9-18.3) in the chemotherapy arm.

Significantly prolonged OS, reducing the risk of death by 53% compared to treatment with chemotherapy (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P

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