|Seattle Genetics and Astellas Announce Progress in Enfortumab Vedotin Urothelial Cancer Clinical Development Program|
-Enrollment of EV-201 Pivotal Trial Cohort Designed to Support Potential Expedited Registration Pathway in the U.S. Completed-
-First Patient Dosed in Phase 3 Global Confirmatory Trial-
The companies expect to report topline efficacy and safety results from
this first cohort of the EV-201 trial, which is intended to support
potential registration under the U.S. Food and Drug Administration’s
The companies also today announced dosing of the first patient in EV-301,
a global, randomized phase 3 clinical trial evaluating enfortumab
vedotin in patients with previously treated locally advanced or
metastatic urothelial cancer. The EV-301 trial is intended to support a
broader global registration strategy and to serve as the confirmatory
randomized trial in the U.S. for EV-201. Enfortumab vedotin has been
granted Breakthrough Therapy Designation by the
“With enfortumab vedotin, we have the opportunity to address some of the
unmet need in advanced urothelial cancer,” said
“Despite recent treatment advances, the unfortunate reality is that many
patients with metastatic urothelial cancer currently find that their
disease will progress after anti-PD-1 or PD-L1 therapy, highlighting the
need to identify additional therapeutic options,” said
In addition to EV-201 and EV-301, enfortumab vedotin is also under evaluation in a phase 1 clinical trial (EV-103) in combination with pembrolizumab (Keytruda®) in cisplatin-ineligible first-line patients with locally advanced or metastatic urothelial cancer.
About EV-201 Trial
EV-201 is an ongoing single-arm, single-agent pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a checkpoint inhibitor, including those who had also been treated with a platinum chemotherapy (first cohort) and those who were cisplatin ineligible / platinum naïve (second cohort). Approximately 120 patients were enrolled in the first cohort at multiple centers. The primary endpoint is confirmed objective response rate, per independent review. Secondary endpoints include assessments of response duration, disease control, overall survival, progression-free survival, safety and tolerability. The second cohort continues to enroll cisplatin-ineligible, platinum naïve patients with urothelial cancer who have received a PD-1/PD-L1 inhibitor but not a platinum agent.
About EV-301 Trial
EV-301 trial is a global, open label, randomized phase 3 trial designed to evaluate enfortumab vedotin versus physician’s choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in approximately 550 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/PD-L1 inhibitor and platinum-based therapies. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, overall response rate, disease control rate, duration of response and quality of life.
More information about the enfortumab vedotin clinical trials can be found at https://www.clinicaltrials.gov.
About Urothelial Cancer
According to the
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 identified as an ADC target by Astellas, which is expressed on many solid tumors.
The safety and efficacy of the agent discussed herein 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. 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.
About the Astellas and Seattle Genetics Collaboration
Seattle Genetics Forward Looking Statement
Certain statements made in this press release are forward looking, such
as those, among others, relating to the companies’ expected reporting of
topline efficacy and safety results from the first cohort of the EV-201
trial in the first half of 2019 and the intended use of the data to
support potential registration under the U.S. Food and Drug
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.
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