Arjun Balar, MD from NYU Langone’s Perlmutter Cancer Center discusses Astellas and Seagen Announce Positive Topline Results from Second Cohort of Patients in Phase 2 Pivotal Trial of PADCEV® (enfortumab vedotin-ejfv) in Advanced Urothelial Cancer.
Link To Press Release-
TOKYO and BOTHELL, Wash. — October 12, 2020 — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq:SGEN) today reported promising topline results from the second cohort of patients known as EV-201 in the pivotal single-arm phase 2 clinical trial. The cohort is testing the antibody-drug conjugate PADCEV® (enfortumab vedotin-ejfv) for patients with locally advanced or metastatic urothelial cancer who have not undergone platinum-containing chemotherapy and who have been previously treated with a PD-1/L1 inhibitor and are not suitable for cisplatin. The findings showed a 52 percent objective response rate (ORR) [95 percent confidence interval (CI): 40.8, 62.4] and a median response time of 10.9 months per blinded independent central analysis. Neutropenia, rash, fatigue, elevated lipase, diarrhea, reduced appetite, anemia and hyperglycemia were the most commonly recorded Grade 3 or greater treatment-related adverse events that occurred in more than 5 percent of patients. Data from Cohort 2 of the trial will be presented at the forthcoming scientific congress for presentation and will be discussed with the regulatory authorities.
PADCEV is a first-in-class antibody-drug conjugate (ADC) directed toward Nectin-4, a cell-surface protein that is highly expressed in bladder cancer.1,2 In 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to PADCEV on the basis of findings from the first cohort in this study, which included patients whose disease progressed during or after platition
The most prevalent form of bladder cancer (90% of cases) is urothelial cancer, which can also be located in urothelial cells that line the renal pelvis (where urine collects within the kidney), ureter (tube that connects the kidneys to the bladder) and urethra.3 Approximately 580,000 individuals will be diagnosed with bladder cancer globally in 2020, and bladder cancer will be attributed to approximately 580,000 individuals.