|Seattle Genetics and Astellas Initiate Phase 1b Trial of Enfortumab Vedotin in Combination with Immune Checkpoint Inhibitor Therapies in Locally Advanced or Metastatic Urothelial Cancer|
-ADC Combination Study Focuses on First-Line Treatment-
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“The initiation of EV-103 is an important step in investigating the
utility of enfortumab vedotin in earlier lines of therapy, including the
first-line setting, for locally advanced and metastatic urothelial
cancer, where patients ineligible for cisplatin-based chemotherapy
continue to have limited treatment options,” said
The EV-103 study is a single arm, open label multicenter trial that will enroll up to 85 patients with locally advanced or metastatic urothelial cancer who are ineligible for first line cisplatin-based chemotherapy or have progressed following treatment with a regimen containing platinum-based chemotherapy. Enfortumab vedotin will be administered during weeks one and two of every three-week cycle, and pembrolizumab or atezolizumab will also be administered during week one of this period. The primary objective of the trial is to assess the safety and tolerability of enfortumab vedotin in combination with CPI therapy. Secondary endpoints include the recommended dose in combination with CPIs, overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS), among other measures.
“We are pleased to be moving forward with evaluating enfortumab vedotin
in combination with CPI therapy, as we look to further investigate the
potential of this agent in some of the hardest-to-treat cancers,” said
Enfortumab vedotin is also being studied as monotherapy in a pivotal
clinical trial for patients with advanced urothelial cancer who have
received prior CPI therapy, called EV-201 (NCT03219333), to support
potential registration under the U.S. Food and Drug Administration’s
About Urothelial Cancer
Urothelial cancer is most commonly found in the bladder (90 percent).
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, industry-leading 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.
About the Astellas and Seattle Genetics Collaboration
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 and risk of adverse events as enfortumab vedotin advance
in clinical trials even after promising results in earlier clinical
trials. In addition, as our drug candidates or those of our
collaborators advance in clinical trials, adverse events and/or
regulatory actions may occur which affect the future development of
those drug candidates and possibly other compounds using similar
technology. More information about the risks and uncertainties faced by
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.