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Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer
March 28, 2019 at 3:01 AM EDT
- Companies Plan to Submit Biologics License Application Later This Year -
Enfortumab vedotin is an investigational antibody-drug conjugate (ADC)
that targets Nectin-4, a therapeutic target that is highly expressed in
multiple solid tumors including urothelial cancers. Based on preliminary
results from a phase 1 trial (EV-101), enfortumab vedotin was granted
Breakthrough Therapy designation by the
The companies plan to submit a Biologics License Application (BLA) to
“Despite recent approvals of multiple checkpoint inhibitors for
previously treated locally advanced or metastatic urothelial cancer,
there remains a high unmet need for effective treatments upon
progression after initial chemotherapy and immunotherapy,” said
“After progression on platinum-containing chemotherapy and a PD-1 or
PD-L1 inhibitor, patients with locally advanced or metastatic urothelial
cancer are left with no approved standard of care treatment options,”
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
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.
About The EV-201 Trial
EV-201 is an ongoing single-arm, pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1 or PD-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). The EV-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 at clinical trials.gov.
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 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 Details
Seattle 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
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
data from cohort 1 of the EV-201 trial in upcoming medical conferences,
and plan to submit a Biologics License Application (BLA) to the
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.
3 Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424.
4 Alhalabi O, Shah AY, Lemke EA, Gao J (2019). Immune
checkpoint inhibitors in urothelial cancer. Oncology (
5 National Comprehensive Cancer Network. Bladder Cancer (Version 1.2019). http://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.
6 Data on file at