BOTHELL, Wash., and
TOKYO, July
9, 2018 /PRNewswire/ -- Seattle Genetics, Inc.
(Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and
CEO: Kenji Yasukawa, Ph.D.,
"Astellas") today announced completion of enrollment for the
enfortumab vedotin EV-201 pivotal phase 2 clinical trial cohort of
patients with locally advanced or metastatic urothelial cancer who
have been previously treated with both platinum chemotherapy and a
checkpoint inhibitor (PD-L1 or PD-1). Enfortumab vedotin is an
investigational antibody-drug conjugate (ADC) that targets
Nectin-4.
The companies expect to report topline efficacy and safety
results from this first cohort of the EV-201 trial, which is
intended to support potential registration under the U.S. Food and
Drug Administration's (FDA) accelerated approval pathway, in the
first half of 2019.
The companies also today announced dosing of the first patient
in EV-301, a global, randomized phase 3 clinical trial evaluating
enfortumab vedotin in patients with previously treated locally
advanced or metastatic urothelial cancer. The EV-301 trial is
intended to support a broader global registration strategy and to
serve as the confirmatory randomized trial in the U.S. for EV-201.
Enfortumab vedotin has been granted Breakthrough Therapy
Designation by the FDA for patients with locally advanced or
metastatic urothelial cancer who were previously treated with
checkpoint inhibitors.
"With enfortumab vedotin, we have the opportunity to address
some of the unmet need in advanced urothelial cancer," said
Roger Dansey, M.D., Chief Medical
Officer at Seattle Genetics. "With our partners Astellas, we are
pleased to advance the enfortumab vedotin clinical trial program
with the vision of bringing a new treatment option to patients with
advanced urothelial cancer worldwide."
"Despite recent treatment advances, the unfortunate reality is
that many patients with metastatic urothelial cancer currently find
that their disease will progress after anti-PD-1 or PD-L1 therapy,
highlighting the need to identify additional therapeutic options,"
said Steven Benner, M.D., Senior
Vice President and Global Therapeutic Area Head, Oncology
Development, Astellas. "Following encouraging results from our
ongoing phase 1 study, we and our partners at Seattle Genetics
decided to proceed with these registrational trials. We look
forward to future clinical development milestones for enfortumab
vedotin."
In addition to EV-201 and EV-301, enfortumab vedotin is also
under evaluation in a phase 1 clinical trial (EV-103) in
combination with pembrolizumab (Keytruda®) in
cisplatin-ineligible first-line patients with locally advanced or
metastatic urothelial cancer.
About EV-201 Trial
EV-201 is an ongoing single-arm,
single-agent pivotal phase 2 clinical trial of enfortumab vedotin
for patients with locally advanced or metastatic urothelial cancer
who have been previously treated with a checkpoint inhibitor,
including those who had also been treated with a platinum
chemotherapy (first cohort) and those who were cisplatin ineligible
/ platinum naïve (second cohort). Approximately 120 patients were
enrolled in the first cohort at multiple centers. The primary
endpoint is confirmed objective response rate, per independent
review. Secondary endpoints include assessments of response
duration, disease control, overall survival, progression-free
survival, safety and tolerability. The second cohort continues to
enroll cisplatin-ineligible, platinum naïve patients with
urothelial cancer who have received a PD-1/PD-L1 inhibitor but not
a platinum agent.
About EV-301 Trial
EV-301 trial is a global, open
label, randomized phase 3 trial designed to evaluate enfortumab
vedotin versus physician's choice of chemotherapy (docetaxel,
paclitaxel or vinflunine) in approximately 550 patients with
locally advanced or metastatic urothelial cancer who were
previously treated with a PD-1/PD-L1 inhibitor and platinum-based
therapies. The primary endpoint is overall survival. Secondary
endpoints include progression-free survival, overall response rate,
disease control rate, duration of response and quality of life.
More information about the enfortumab vedotin clinical trials
can be found at https://www.clinicaltrials.gov.
About Urothelial Cancer
According to the American
Cancer Society, urothelial cancer, also known as transitional cell
carcinoma (TCC), is the most common type of bladder
cancer1 (90 percent of cases). Approximately 81,000
people in the U.S. are anticipated to be diagnosed with bladder
cancer during 2018. Bladder cancer is the fourth most common cancer
in men, but is less common in women. Outcomes are poor for people
diagnosed with metastatic disease, with a five-year survival rate
of 4.8 percent.2
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 the agent discussed herein 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. 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.
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.
ADCETRIS® (brentuximab vedotin) utilizes the company's
industry-leading antibody-drug conjugate (ADC) technology and is
currently approved for the treatment of multiple CD30-expressing
lymphomas. Beyond ADCETRIS, the company has established a pipeline
of novel targeted therapies at various stages of clinical testing,
including three in ongoing pivotal trials for solid tumors.
Enfortumab vedotin for metastatic urothelial cancer and tisotumab
vedotin for metastatic cervical cancer utilize our proprietary ADC
technology. Tucatinib, a small molecule tyrosine kinase inhibitor,
is in a pivotal trial for HER2-positive metastatic breast cancer.
In addition, we are leveraging our expertise in empowered
antibodies to build a portfolio of proprietary immuno-oncology
agents in clinical trials targeting hematologic malignancies and
solid tumors. 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
Astellas and Seattle Genetics entered into the
ADC collaboration in January 2007 and expanded it
in November 2009. Under the collaboration, the companies are
co-developing and have options to globally co-commercialize
enfortumab vedotin.
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 topline efficacy and safety results from the first cohort of the
EV-201 trial in the first half of 2019 and the intended use of the
data to support potential registration under the U.S. Food and Drug
Administration's (FDA) accelerated approval pathway, 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 possible delays in
the availability of data from EV-201 and that the data from EV-201
may not be sufficient to support accelerated approval, and the
inability to show sufficient activity in the 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 Quarterly Report on Form 10-Q for the
quarter ended March 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 Cancer Society. What is bladder cancer?
https://www.cancer.org/cancer/bladder-cancer/about/what-is-bladder-cancer.html.
Accessed 05-08-2018.
2 National Cancer Institute. Surveillance, Epidemiology,
and End Results Program. Cancer stat facts: bladder cancer.
https://seer.cancer.gov/statfacts/html/urinb.html. Accessed
05-08-2018.
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SOURCE Astellas Pharma Inc.