TOKYO and BOTHELL, Wash. – October 12, 2021 – Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that patient enrollment was completed in Cohort K of the phase 1b/2 EV-103 clinical trial (also known as KEYNOTE-869). The cohort is evaluating PADCEV® (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. Merck is known as MSD outside the United States and Canada.
“Completing enrollment in this study is an important step in investigating the potential for the combination of PADCEV and KEYTRUDA to treat metastatic urothelial cancer,” said Roger Dansey, M.D., Chief Medical Officer, Seagen. “If results of this study are compelling, we may have the opportunity to submit them to the FDA as part of an application for accelerated approval.”
EV-103 is a multi-cohort, open-label, multicenter phase 1b/2 trial of PADCEV alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive bladder cancer and in locally advanced or metastatic urothelial cancer in first- or second-line settings. Key outcome measures of EV-103 Cohort K are objective response rate (ORR) per blinded independent central review (BICR) using RECIST 1.1 and duration of response (DoR). The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation in February 2020 for PADCEV in combination with KEYTRUDA for patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. The designation is based on results from the dose-escalation cohort and expansion cohort A of the EV-103 trial.
“The FDA’s Breakthrough Therapy designation is based on preliminary data on the combination of PADCEV and KEYTRUDA,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Head of Development Therapeutic Areas, Astellas. “Both Cohort K of EV-103 and our ongoing, broader phase 3 EV-302 study are evaluating this platinum-free combination in patients with previously untreated advanced urothelial cancers.” EV-302 is also known as KEYNOTE-A39.
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