Professor Thomas Powles, MD of Barts Cancer Centre, Queen Mary University of London speaks about Seattle Genetics and Astellas Announce PADCEV® (enfortumab vedotin-ejfv) Significantly Improved Overall Survival in Phase 3 Trial in Previously Treated Locally Advanced or Metastatic Urothelial Cancer.
Link to Press Release -
BOTHELL, Wash. & TOKYO—(BUSINESS WIRE)—Seattle Genetics, Inc. (Nasdaq: SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today reported that their primary endpoint of overall survival relative to chemotherapy was reached by a phase 3 trial of PADCEV® (enfortumab vedotin-ejfv). Following a planned interim study, the findings were reviewed by an independent Data Management Committee. For adult patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and a PD-1/L1 inhibitor, the global EV-301 clinical trial compared PADCEV with chemotherapy.
In the study, PADCEV significantly enhanced overall survival (OS), decreasing the risk of death by 30 percent (Hazard Ratio [HR]=0.70; [95 percent Confidence Interval (CI): 0.56, 0.89]; p=0.001). A secondary endpoint, PADCEV also dramatically improved progression-free survival (PFS) with a 39 percent decrease in disease progression or death risk (HR=0.61 [95 percent CI: 0.50, 0.75]; p<0.00001).
Adverse events were consistent with those reported in the U.S. for patients in the PADCEV arm of the study. Prescribing Details for more than 5% of patients with rash, hyperglycemia, reduced neutrophil count, weakness, anemia, and decreased appetite as the most common Grade 3 or greater adverse event(s). Data from EV-301 will be sent to the forthcoming scientific congress for presentation. The chance to obtain PADCEV will be given to patients in the chemotherapy arm of the study.
The findings will be filed with the U.S. As the confirmatory trial following the accelerated approval of the drug in 2019, the Food and Drug Administration (FDA). The aim of the EV-301 is also to help global registration.
About 580,000 individuals will be diagnosed with bladder cancer globally in 2020.1 Urothelial cancer accounts for 90% of all bladder cancers and can also be located in the renal pelvis (where urine collects inside the kidney), ureter (the tube that connects the kidneys to the bladder), and urethra.2 About 80% of individuals do not respond to platinum-positive PD-1 or PD-L1 inhibitors.
Concerning the EV-301 Trial
The EV-301 (NCT03474107) trial is a national, multicenter, open-label, randomized phase 3 trial designed to test PADCEV versus doctor's choice of chemotherapy (docetaxel, paclitaxel, or vinflunine) in approximately 600 locally advanced or metastatic urothelial cancer patients who have been previously treated with a platinum-based PD-1 or PD-L1 inhibitor. Compared to those treated with chemotherapy, the primary outcome is the overall survival of participants treated with PADCEV. Secondary endpoints include progression-free survival, response length, and overall response rate, as well as the measurement of criteria of safety/tolerability and quality of life.
Please visit www.clinicaltrials.gov for more information on the EV-301 clinical trial.