BOTHELL, Wash. and TOKYO, March 28,
2019 /PRNewswire/ -- Seattle Genetics, Inc. (Nasdaq: SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.,
"Astellas") today announced positive topline results from the first cohort of patients in a pivotal phase 2
single-arm clinical trial known as EV-201. The cohort is evaluating enfortumab vedotin for the treatment of
patients with locally advanced or metastatic urothelial cancer who have received previous treatment with both platinum-containing
chemotherapy and a PD-1 or PD-L1 inhibitor. Results showed a 44 percent objective response rate (ORR) per blinded independent
central review. The duration of response was consistent with that recently reported in the previous phase 1 study
(EV-101). The most common treatment-related adverse events included fatigue, alopecia, decreased appetite, rash and
peripheral neuropathy. The data will be presented at an upcoming medical meeting.
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 U.S. Food and Drug Administration (FDA) for
patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following treatment
with a PD-1 or PD-L1 inhibitor.
The companies plan to submit a Biologics License Application (BLA) to the FDA later this year based on the results from the
EV-201 trial (cohort 1). A global, randomized phase 3 clinical trial (EV-301) is ongoing and intended to support global
registration as well as to serve as the confirmatory randomized trial for enfortumab vedotin for patients with locally advanced
or metastatic urothelial cancer who have been previously treated with a platinum-containing chemotherapy and a PD-1 or PD-L1
inhibitor.
"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 Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "These results
for enfortumab vedotin indicate it may be able to help patients whose urothelial
cancer progresses following treatment with standard chemotherapy and a PD-1 or PD-L1 inhibitor."
"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," said Steven
Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. "These data are
very encouraging, and we look forward to discussing the data with relevant health authorities."
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 the United States.2 Globally,
approximately 549,000 people were diagnosed with bladder cancer last year, and there were approximately 200,000 deaths
worldwide.3 Approximately 80 percent of people do not respond to PD-1 or PD-L1 inhibitors after a platinum-containing
therapy has failed as an initial treatment for advanced disease.4 There are currently no approved therapies for
metastatic urothelial cancer once it has progressed after chemotherapy and a PD-1 or PD-L1 inhibitor.5
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.
About Seattle Genetics
Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes
transformative therapies targeting cancer to make a meaningful difference in people's lives. The company is headquartered in
Bothell, Washington, and has a European office in Switzerland.
For more information on our robust pipeline, visit www.seattlegenetics.com and follow @SeattleGenetics on Twitter.
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the
health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information,
please visit our website at https://www.astellas.com/en.
About the Astellas and Seattle Genetics Collaboration
Seattle Genetics and Astellas are co-developing enfortumab vedotin under a collaboration that was entered into in 2007, and
expanded in 2009. Under the collaboration, the companies are sharing costs and profits on a 50:50 basis worldwide.
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 FDA in the near term under FDA's Accelerated Approval program based on the results of
the pivotal EV-201 trial; conduct of a comprehensive clinical development program for enfortumab vedotin, which includes an
ongoing randomized phase 3 confirmatory trial (EV-301) intended to support global registration in locally advanced or metastatic
urothelial cancer; and 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 that the data from EV-201 may not be selected for publication at medical conferences; the possibility
of delays in the submission of a BLA to the FDA; that the data from EV-201 may not be sufficient to support accelerated approval;
and the inability to show sufficient activity in EV-301 and subsequent clinical trials; the risk of adverse events or safety
signals; and the possibility of adverse regulatory actions as enfortumab vedotin advances in clinical trials even after promising
results in earlier clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained
under the caption "Risk Factors" included in the company's Annual Report on Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention
or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or
otherwise.
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.
1 American Society of Clinical Oncology. Bladder Cancer: Introduction (10-2017). https://www.cancer.net/cancer-types/bladder-cancer/introduction.
2 https://gco.iarc.fr/today/data/factsheets/populations/840-united-states-of-america-fact-sheets.pdf.
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
(Williston Park) 33(1): 1108.
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 Seattle Genetics.
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