Urothelial cancer is the most common type of bladder cancer (90 percent of cases).1 In 2018, more than 82,000 people were diagnosed with bladder cancer in the United States.2 Globally, approximately 549,000 people were diagnosed with bladder cancer last year, and there were approximately 200,000 deaths worldwide.3 Approximately 80 percent of people do not respond toPD-1 orPD-L1 inhibitors after a platinum-containing therapy has failed as an initial treatment for advanced disease.4 There are currently no approved therapies for metastatic urothelial cancer once it has progressed after chemotherapy and aPD-1 orPD-L1 inhibitor.5
In addition to the ongoing confirmatory phase 3 study intended to also support global registration, development of enfortumab vedotin is underway in earlier lines of treatment for locally advanced or metastatic urothelial cancer, including in newly diagnosed patients in combination with pembrolizumab and/or platinum chemotherapy.
AboutEV-201 Trial
EV-201 is an ongoingsingle-arm, pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with aPD-1 orPD-L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy and who are ineligible for cisplatin (cohort 2). TheEV-201 phase 2 trial continues to enroll patients in cohort 2. In cohort 1, 128 patients were enrolled at multiple centers internationally.6 The primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability. More information about enfortumab vedotin clinical trials can be found atclinical trials.gov.
About Enfortumab Vedotin
Enfortumab vedotin is an investigational ADC composed of ananti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent (MMAE) using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targetsNectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumors.
The safety and efficacy of enfortumab vedotin are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated.
Seattle Genetics Conference Call DetailsSeattle Genetics’ management will host a conference call and webcast to discuss the announcement of enfortumab vedotin topline data. The event will be held today at 6:00 a.m. Pacific Time (PT); 9:00 a.m. Eastern Time (ET). The live event will be available from the Seattle Genetics website atwww.seattlegenetics.com, under the Investors section, or by calling866-288-0540 (domestic) or786-460-7199 (international). The conference ID is 3807860. A replay of the live event will be available starting on March 28, 2019 on the Seattle Genetics website or by calling888-203-1112 (domestic) or719-457-0820 (international), using conference ID 3807860. The telephone replay will be available until 5:00 p.m. PT on April 1, 2019.
About Seattle Genetics
Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. The company is headquartered in Bothell, Washington, and has a European office in Switzerland. For more information on our robust pipeline, visitwww.seattlegenetics.com and follow @SeattleGenetics on Twitter.
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