|Seattle Genetics and Astellas Initiate Pivotal Trial of Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer|
-Solid Tumor Antibody-Drug Conjugate (ADC) Enfortumab Vedotin to be Evaluated as a Monotherapy in Patients Previously Treated with a Checkpoint Inhibitor-
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“Locally advanced or metastatic urothelial cancers are often aggressive
and treatment-resistant. Treatment options are limited for those many
patients who do not respond to chemotherapy and checkpoint inhibitors,
or CPIs. In addition, there are no
The primary endpoint of the single-arm, open-label trial is confirmed objective response rate (ORR), per independent review. Secondary endpoints include assessments of overall survival, progression free-survival, safety and tolerability. The study will enroll approximately 120 patients at multiple centers globally, and enfortumab vedotin will be administered three of every four weeks for the duration of treatment.
“The initiation of the EV-201 clinical trial demonstrates our continued
commitment to patients living with locally advanced or metastatic
urothelial cancer,” said
The companies also plan to initiate a combination trial of enfortumab vedotin with CPI therapy in late 2017.
For more information about the phase 2 pivotal trial, including enrolling centers, please visit www.clinicaltrials.gov.
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
Nectin-4 is highly expressed in urothelial cancers, particularly in bladder cancer. Preclinical data demonstrate that enfortumab vedotin binds to Nectin-4 on cancer cells and releases the cell-killing agent into these target cells upon internalization.
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 possibility that
EV-201 will generate data that would be sufficient to support potential
registration of enfortumab vedotin under the U.S. Food and Drug
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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