BOTHELL, Wash. and TOKYO, Sept. 16,
2019 /PRNewswire/ -- Seattle Genetics, Inc. (Nasdaq:SGEN)
and Astellas Pharma Inc. (TSE: 4503, President and CEO:
Kenji Yasukawa, Ph.D., "Astellas")
today announced that the U.S. Food and Drug Administration (FDA)
has accepted the Biologics License Application (BLA) for the
investigational agent enfortumab vedotin and granted Priority
Review 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
filing 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 oral presentation at the annual meeting of the
American Society of Clinical Oncology (ASCO) in June 2019. Under the Prescription Drug User Fee
Act (PDUFA), the FDA has set a target action date of March 15, 2020. Enfortumab vedotin is a novel
investigational antibody-drug conjugate (ADC) that targets
Nectin-4, a protein that is highly expressed in urothelial
cancers.1
The FDA granted enfortumab vedotin Breakthrough Therapy
designation in March 2018, for
patients with locally advanced or metastatic urothelial cancer
whose disease has progressed during or following checkpoint
inhibitor therapy.
"The FDA's filing of the application for enfortumab vedotin and
granting of Priority Review is a significant milestone toward
offering a new treatment to patients with advanced urothelial
cancer who have a clear unmet need," said Roger Dansey, M.D., Chief Medical Officer
at Seattle Genetics.
"If approved, enfortumab vedotin will likely play an important
role in the treatment of advanced urothelial cancer, and we look
forward to working with the FDA as the review process advances,"
said Andrew Krivoshik, M.D., Ph.D.,
Senior Vice President and Oncology Therapeutic Area Head at
Astellas.
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, 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). In cohort 1, 128 patients were
enrolled at multiple centers internationally.2 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). In 2018, more than 82,000 people were diagnosed
with bladder cancer in the United
States.3 Globally, approximately 549,000 people
were diagnosed with bladder cancer last year, and there were
approximately 200,000 deaths worldwide.4
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 Zug, 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, 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 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 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 June 30, 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.
- Astellas Pharma Global Development, Inc. Bladder Cancer (2019).
https://bladdercancerjournal.com/study-escalating-doses-asg-22ce-given-monotherapy-subjects-metastatic-urothelial-cancer-and-other
- Data on file at Seattle Genetics.
- American Society of Clinical Oncology. Bladder Cancer:
Statistics (05-2019).
https://www.cancer.net/cancer-types/bladder-cancer/statistics
- 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.
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SOURCE Astellas Pharma Inc.