|View printer-friendly version|
Seattle Genetics and Astellas Present at ASCO 2018 on Enfortumab Vedotin in Patients with Locally Advanced or Metastatic Urothelial Cancer Previously Treated with Checkpoint Inhibitor Therapy
June 3, 2018 at 9:00 AM EDT
-Updated Data from Phase 1 EV-101 Study Highlighted in
“Many patients with locally advanced or metastatic urothelial cancer
previously treated with checkpoint inhibitors have a poor prognosis and
limited subsequent treatment options,”said Jonathan E.
Rosenberg, M.D., medical oncologist at
“We are encouraged by these updated data for enfortumab vedotin, which
further support the rapid expansion of a comprehensive clinical trial
program and the registrational study that is already underway in
metastatic urothelial cancer,” said
The following updated results were presented by Dr. Rosenberg:
Updated Results from the Enfortumab Vedotin Phase 1 (EV-101) Study in
Patients with Metastatic Urothelial Cancer: (Abstract #4504, oral
abstract session on
EV-201 Study: A Single-Arm, Open-Label, Multicenter Study of
Enfortumab Vedotin for Treatment of Patients with Locally Advanced or
Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint
Inhibitor Therapy (Abstract #TPS4590, poster session on
In addition, the EV-201 trial in progress poster was presented at the meeting. 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 checkpoint inhibitor therapy, including those who had also been treated with a platinum chemotherapy and those who were platinum naive.
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.
Seattle Genetics Forward Looking Statement
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the therapeutic
potential of enfortumab vedotin, its possible safety, efficacy, and
therapeutic uses and anticipated development activities including future
clinical trials and intended regulatory actions. Actual results or
developments may differ materially from those projected or implied in
these forward-looking statements. Factors that may cause such a
difference include the inability to show sufficient activity in the
clinical trials, the risk of adverse events or safety signals, and the
possibility of adverse regulatory actions as enfortumab vedotin advance
in clinical trials even after promising results in earlier clinical
trials. More information about the risks and uncertainties faced by
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.
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.