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Seattle Genetics and Astellas Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer
July 16, 2019 at 8:00 AM EDT
-Submission Based on Pivotal Phase 2 Trial Results Recently Presented at Annual Meeting of
The submission is based on results from the first cohort of patients in the EV-201 pivotal phase 2 clinical trial that were presented as a late-breaking abstract at the annual meeting of the
“There is an urgent need for new therapies for patients with advanced urothelial cancer, and we look forward to working with our partner Astellas and the
“There are limited treatment options for patients with advanced urothelial cancer, and we are encouraged by the results observed in the pivotal trial for enfortumab vedotin,” said
Based on preliminary results from a phase 1 trial (EV-101), the
A global, randomized phase 3 confirmatory clinical trial (EV-301) is ongoing and is intended to support global registrations. Another ongoing trial, EV-103, is evaluating enfortumab vedotin in earlier lines of treatment for patients with locally advanced or metastatic urothelial cancer, including in combination with pembrolizumab and/or platinum chemotherapy in newly diagnosed patients as well as patients whose cancer progressed from earlier-stage disease.
About the EV-201 Trial
EV-201 is an ongoing single-arm, pivotal phase 2 clinical trial of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy or who are ineligible for cisplatin (cohort 2). In cohort 1, 128 patients were enrolled at multiple centers internationally.ii 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. EV-201 continues to enroll patients in cohort 2.
More information about enfortumab vedotin clinical trials can be found at clinical trials.gov.
About Urothelial Cancer
Urothelial cancer is the most common type of bladder cancer (90 percent of cases).iii In 2018, more than 82,000 people were diagnosed with bladder cancer in
About Enfortumab Vedotin
Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule that is expressed on many solid tumors, and that has been identified as an ADC target by Astellas.
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 or become commercially available for the uses being investigated.
About the Astellas and Seattle Genetics Collaboration
Seattle Genetics Forward Looking Statements
Certain statements made in this press release are forward looking, such as those, among others, relating to the potential
Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.
i Vlachostergios P, Jakubowski C, Niaz J, et al. (2018). Antibody-Drug Conjugates in Bladder Cancer. Bladder Cancer (Version 4.2018). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6087439/pdf/blc-4-blc180169.pdf
ii Data on file at
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