TOKYO and BOTHELL, Wash., Nov. 8,
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-103, a phase 1b clinical trial evaluating the safety
and tolerability of enfortumab vedotin in combination with
pembrolizumab or atezolizumab, two types of immune checkpoint
inhibitor (CPI) therapies, for first- or second-line treatment of
patients with locally advanced or metastatic urothelial cancer.
Enfortumab vedotin is an investigational antibody-drug conjugate
(ADC) designed to deliver the cell-killing agent monomethyl
auristatin E (MMAE) to the target Nectin-4.
"The initiation of EV-103 is an important step in investigating
the utility of enfortumab vedotin in earlier lines of therapy,
including the first-line setting, for locally advanced and
metastatic urothelial cancer, where patients ineligible for
cisplatin-based chemotherapy continue to have limited treatment
options," said Jonathan Drachman,
M.D., Chief Medical Officer and Executive Vice President, Research
and Development at Seattle Genetics. "This study represents Seattle
Genetics' third ADC under clinical evaluation in combination with
CPIs, highlighting our vision that ADCs could be the preferred
partners for immuno-oncology agents for patients with solid tumors
and hematological cancers."
The EV-103 study is a single arm, open label multicenter trial
that will enroll up to 85 patients with locally advanced or
metastatic urothelial cancer who are ineligible for first line
cisplatin-based chemotherapy or have progressed following treatment
with a regimen containing platinum-based chemotherapy. Enfortumab
vedotin will be administered during weeks one and two of every
three-week cycle, and pembrolizumab or atezolizumab will also be
administered during week one of this period. The primary objective
of the trial is to assess the safety and tolerability of enfortumab
vedotin in combination with CPI therapy. Secondary endpoints
include the recommended dose in combination with CPIs, overall
response rate (ORR), duration of response (DOR), progression-free
survival (PFS), and overall survival (OS), among other
measures.
"We are pleased to be moving forward with evaluating enfortumab
vedotin in combination with CPI therapy, as we look to further
investigate the potential of this agent in some of the
hardest-to-treat cancers," said Steven
Benner, M.D., Senior Vice President and Global Therapeutic
Area Head, Oncology Development at Astellas. "Many patients do not
respond to or relapse after treatment with CPIs, and we are
committed to exploring additional ways to potentially address the
unmet needs of the urothelial cancer community."
Enfortumab vedotin is also being studied as monotherapy in a
pivotal clinical trial for patients with advanced urothelial cancer
who have received prior CPI therapy, called EV-201 (NCT03219333),
to support potential registration under the U.S. Food and Drug
Administration's (FDA) accelerated approval regulations.
For more information about the EV-103 clinical trial, 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 Astellas, which is expressed on many
solid tumors.
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 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 Nov. 6, 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.
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.
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SOURCE Astellas Pharma Inc.