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Astellas and Seagen Announce Phase 3 Trial Results Demonstrating Survival Advantage of PADCEV® (enfortumab vedotin-ejfv) in Patients with Previously Treated Advanced Urothelial Cancer

Published: 2021-02-12 19:15:00 ET

- Findings from the EV-301 Trial Showed Significant Improvements in Overall Survival and Progression-Free Survival Compared to Chemotherapy -

- EV-301 Intended to Support Global Registrations, Convert Accelerated to Regular Approval in U.S. -

- Data Published in the New England Journal of Medicine, Presented at the 2021 ASCO Genitourinary Cancers Symposium -

TOKYO and BOTHELL, Wash., Feb. 12, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced primary results from the phase 3 EV-301 trial comparing PADCEV® (enfortumab vedotin-ejfv) to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. At the time of pre-specified interim analysis, patients who received PADCEV in the trial lived a median of 3.9 months longer than those who received chemotherapy. Median overall survival was 12.9 vs. 9.0 months, respectively (HR=0.70 [95 percent Confidence Interval (CI): 0.56-0.89], p=0.001). For patients in the PADCEV arm of the trial, maculopapular rash, fatigue and decreased neutrophil count were the most frequent Grade 3 or greater treatment-related adverse events (TRAEs) occurring in more than 5 percent of patients.

Urothelial cancer is the most common type of bladder cancer and can also be found in the renal pelvis, ureter and urethra.1

The findings were published in the New England Journal of Medicine and presented during the virtual scientific program of the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) (Abstract 393).

"Improving survival is especially meaningful in patients who have had their cancer progress following chemotherapy or other treatment," said Daniel P. Petrylak, M.D., Professor of Medicine and of Urology, Yale Cancer Center, and corresponding author of the published study.

"Enfortumab vedotin is the first medicine to reduce the risk of death compared to chemotherapy in patients with locally advanced or metastatic urothelial cancer who have received a platinum-containing chemotherapy and an immunotherapy," said Professor Thomas Powles, M.D., Director, Barts Cancer Centre, Queen Mary University of London, who presented results at ASCO GU.

Patients who received PADCEV in the trial also showed improvement in the following secondary endpoints:

Median progression-free survival, which is the time without progression of cancer, was 5.6 months for PADCEV vs. 3.7 months for chemotherapy (HR=0.62 [95 percent CI: 0.51-0.75]; p

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