Under the terms of the agreement, the three companies will conduct and fund a global, registrational phase 3 clinical trial to be led by
'We look forward to initiating a randomized phase 3 trial in patients with previously untreated locally advanced or metastatic urothelial cancer,' said
'An unmet medical need exists for previously untreated patients with metastatic urothelial cancer, and we are committed to studying enfortumab vedotin in combination with other agents in different stages of urothelial cancer,' said
Enfortumab vedotin is currently under review by the
KEYTRUDA is a registered trademark of
About Urothelial Cancer
Urothelial cancer is the most common type of bladder cancer (90 percent of cases).1 In 2019, more than 80,000 people will be diagnosed with bladder cancer in
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
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 or become commercially available for the uses being investigated.
About
About Astellas
About the Astellas and Seattle Genetics Collaboration
Seattle Genetics Forward Looking Statements
Certain statements made in this press release are forward looking, such as those, among others, relating to clinical development plans including the proposed phase 3 trial of enfortumab vedotin in combination with pembrolizumab as a potential treatment option for previously untreated metastatic urothelial cancer; the therapeutic potential of enfortumab vedotin including its possible safety, efficacy, and therapeutic uses, including in previously untreated metastatic urothelial cancer, and the potential FDA approval of enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. 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 possibility that ongoing and subsequent clinical trials of enfortumab vedotin, including the proposed phase 3 trial of enfortumab vedotin in combination with pembrolizumab, may fail to establish sufficient efficacy; that adverse events or safety signals may occur; that adverse regulatory actions or other setbacks could occur as enfortumab vedotin advances in clinical trials even after promising results in earlier clinical trials and that the Biologics License Application submission and any future potential supplemental Biologics License Application submissions for enfortumab vedotin may not be approved by the FDA in a timely manner or at all or with the requested label(s). 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.
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.
Contact:
Tel: (425) 527-4641
Email: mgreer@seagen.com
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