TOKYO and BOTHELL, Wash., Oct.
10, 2017 /PRNewswire/ -- Astellas Pharma Inc. (TSE:
4503, President and CEO: Yoshihiko
Hatanaka, "Astellas") and Seattle Genetics
Inc., (NASDAQ: SGEN) today announced dosing of the first
patient in EV-201, a registrational phase 2 clinical trial of
enfortumab vedotin for patients with locally advanced or metastatic
urothelial cancer who have been previously treated with checkpoint
inhibitor (CPI) therapy. The EV-201 study will assess the antitumor
activity and safety of enfortumab vedotin to support potential
registration under the U.S. Food and Drug Administration's (FDA)
accelerated approval regulations.
"Locally advanced or metastatic urothelial cancers are often
aggressive and treatment-resistant. Treatment options are limited
for those many patients who do not respond to chemotherapy and
checkpoint inhibitors, or CPIs. In addition, there are no
FDA-approved therapies for patients who progress following CPI
treatment," said Jonathan Drachman,
M.D., Chief Medical Officer and Executive Vice President, Research
and Development at Seattle Genetics. "Initiation of this pivotal
phase 2 trial of enfortumab vedotin is a significant advance toward
our goal of providing a new treatment option for patients with
locally advanced or metastatic urothelial cancer."
The primary endpoint of the single-arm, open-label trial is
confirmed objective response rate (ORR), per independent review.
Secondary endpoints include assessments of overall survival,
progression free-survival, safety and tolerability. The study will
enroll approximately 120 patients at multiple centers globally, and
enfortumab vedotin will be administered three of every four weeks
for the duration of treatment.
"The initiation of the EV-201 clinical trial demonstrates our
continued commitment to patients living with locally advanced or
metastatic urothelial cancer," said Steven
Benner, M.D., Senior Vice President and Global Therapeutic
Area Head, Oncology Development at Astellas. "Our decision to move
forward with this registrational trial is based on the results of
our ongoing Phase 1 study, and we look forward to future clinical
development milestones for enfortumab vedotin."
The companies also plan to initiate a combination trial of
enfortumab vedotin with CPI therapy in late 2017.
For more information about the phase 2 pivotal trial, including
enrolling centers, please visit www.clinicaltrials.gov.
About Urothelial Cancer
Urothelial cancer is most
commonly found in the bladder (90 percent). According to the
American Cancer Society, approximately 79,000 people in the U.S.
will be diagnosed with bladder cancer during 2017 and almost 17,000
will die from the disease. Outcomes are poor for patients diagnosed
with metastatic disease, with a five-year survival rate of five
percent.
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, industry-leading linker technology.
Enfortumab vedotin targets Nectin-4, a cell adhesion molecule
identified as an ADC target by Agensys (an affiliate of Astellas),
which is expressed on many solid tumors.
Nectin-4 is highly expressed in urothelial cancers, particularly
in bladder cancer. Preclinical data demonstrate that enfortumab
vedotin binds to Nectin-4 on cancer cells and releases the
cell-killing agent into these target cells upon
internalization.
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. We focus on Urology, Oncology, Immunology, Nephrology and
Neuroscience as prioritized therapeutic areas while advancing new
therapeutic areas and discovery research leveraging new
technologies/modalities. We are also creating new value by
combining internal capabilities and external expertise in the
medical/healthcare business. Astellas is on the forefront of
healthcare change to turn innovative science into value for
patients. For more information, please visit our website at
https://www.astellas.com/en.
About Seattle Genetics
Seattle Genetics is an
innovative biotechnology company dedicated to improving the lives
of people with cancer through novel antibody-based therapies. The
company's industry-leading antibody-drug conjugate (ADC) technology
harnesses the targeting ability of antibodies to deliver
cell-killing agents directly to cancer cells. Seattle Genetics
commercializes ADCETRIS® (brentuximab vedotin) for the
treatment of several types of CD30-expressing lymphomas. The
company is also advancing a robust pipeline of novel therapies for
solid tumors and blood-related cancers designed to address
significant unmet medical needs and improve treatment outcomes for
patients. More information can be found at
www.seattlegenetics.com and follow @SeattleGenetics on
Twitter.
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 of
the statements made in this press release are forward looking, such
as those, among others, relating to the possibility that EV-201
will generate data that would be sufficient to support potential
registration of enfortumab vedotin under the U.S. Food and Drug
Administration's (FDA) accelerated approval regulations,
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 the inability to
show sufficient activity in the clinical trials and risk of adverse
events as enfortumab vedotin advance in clinical trials even after
promising results in earlier clinical trials. In addition, as our
drug candidates or those of our collaborators advance in clinical
trials, adverse events and/or regulatory actions may occur which
affect the future development of those drug candidates and possibly
other compounds using similar technology. 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 August 1, 2017 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.
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.
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