TOKYO and BOTHELL, Wash., July
16, 2019 /PRNewswire/ -- Astellas Pharma Inc. (TSE:
4503, President and CEO: Kenji
Yasukawa, Ph.D., "Astellas") and Seattle Genetics,
Inc. (Nasdaq:SGEN) today announced submission of a Biologics
License Application for accelerated approval to the U.S. Food and
Drug Administration for the investigational agent 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.
The submission is based on results from the first cohort of
patients in the EV-201 pivotal phase 2 clinical trial that were
presented as a late-breaking abstract at the annual meeting of the
American Society of Clinical Oncology (ASCO) in June. Enfortumab
vedotin is an investigational antibody-drug conjugate (ADC) that
targets Nectin-4, a protein that is highly expressed in urothelial
cancers.i
"There are limited treatment options for patients with advanced
urothelial cancer, and we are encouraged by the results observed in
the pivotal trial for enfortumab vedotin," said Andrew Krivoshik, M.D., Ph.D., Senior Vice
President and Oncology Therapeutic Area Head at Astellas.
"There is an urgent need for new therapies for patients with
advanced urothelial cancer, and we look forward to working with our
partner Astellas and the FDA on the review of this application,"
said Roger Dansey, M.D., Chief
Medical Officer at Seattle Genetics.
Based on preliminary results from a phase 1 trial (EV-101), the
FDA granted enfortumab vedotin Breakthrough Therapy designation for
patients with locally advanced or metastatic urothelial cancer
whose disease has progressed during or following checkpoint
inhibitor therapy.
A global, randomized phase 3 confirmatory clinical trial
(EV-301) is ongoing and is intended to support global
registrations. Another ongoing trial, EV-103, is evaluating
enfortumab vedotin in earlier lines of treatment for patients with
locally advanced or metastatic urothelial cancer, including in
combination with pembrolizumab and/or platinum chemotherapy in
newly diagnosed patients as well as patients whose cancer
progressed from earlier-stage disease.
About the EV-201 Trial
EV-201 is an ongoing single-arm, pivotal phase 2 clinical trial
of enfortumab vedotin in patients with locally advanced or
metastatic urothelial cancer who have been previously treated with
a PD-1/L1 inhibitor and a platinum-containing chemotherapy (cohort
1) and those who have not received a platinum-containing
chemotherapy or who are ineligible for cisplatin (cohort
2). In cohort 1, 128 patients were enrolled at multiple
centers internationally.ii 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. EV-201 continues to enroll
patients in cohort 2.
More information about enfortumab vedotin clinical trials can be
found at clinical trials.gov.
About Urothelial Cancer
Urothelial cancer is the most common type of bladder cancer (90
percent of cases).iii In 2018, more than 82,000 people
were diagnosed with bladder cancer in the
United States. Globally, approximately 549,000 people were
diagnosed with bladder cancer last year, and there were
approximately 200,000 deaths worldwide.iv
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 that is expressed on many solid tumors,
and that has been identified as an ADC target by Astellas.
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 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 Statements
Certain statements made in this press release are forward
looking, such as those, among others, relating to 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; the conduct of an ongoing randomized phase 3
confirmatory clinical trial (EV-301) intended to support global
registrations, and of a trial (EV-103) evaluating enfortumab
vedotin in earlier lines of treatment for patients with locally
advanced or metastatic urothelial cancer, including in combination
with pembrolizumab and/or platinum chemotherapy in newly diagnosed
patients as well as patients whose cancer progressed from
earlier-stage disease; and the therapeutic potential of enfortumab
vedotin including its possible safety, efficacy, and
therapeutic uses. 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 the Biologics License Application submission based
on the EV-201 trial may not be accepted for filing by, or
ultimately approved by, the FDA in a timely manner or at all or
with the requested label; that the data from EV-201 may not be
sufficient to support accelerated approval; that EV-301 and EV-103
and subsequent clinical trials may fail to establish sufficient
efficacy; that adverse events or safety signals may occur; and that
adverse regulatory actions could occur 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 Quarterly Report on Form 10-Q
for the quarter ended March 31, 2019
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, except as required by law.
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.
i Vlachostergios P, Jakubowski C, Niaz J, et al.
(2018). Antibody-Drug Conjugates in Bladder Cancer. Bladder Cancer
(Version 4.2018).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6087439/pdf/blc-4-blc180169.pdf
ii Data on file at Seattle Genetics
iii American Society of Clinical Oncology.
Bladder Cancer: Introduction (05-2019).
https://www.cancer.net/cancer-types/bladder-cancer/introduction.
iv International Agency for Research on Cancer.
Cancer tomorrow: bladder. http://gco.iarc.fr/tomorrow.
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