-Solid Tumor Antibody-Drug Conjugate (ADC)
Enfortumab Vedotin to be Evaluated as a Monotherapy in Patients
Previously Treated with a Checkpoint Inhibitor-
Seattle Genetics, Inc. (NASDAQ: SGEN) and Astellas Pharma Inc.
(TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”)
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.
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the full release here:
http://www.businesswire.com/news/home/20171010005790/en/
“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 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 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 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 on Astellas, please visit our
website at 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 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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version on businesswire.com: http://www.businesswire.com/news/home/20171010005790/en/
Seattle Genetics Contacts:For MediaKavita V.
ShahAssociate Director, Corporate
Communications425-527-4188kshah@seagen.comorFor InvestorsPeggy
PinkstonVice President, Investor
Relations425-527-4160ppinston@seagen.comorAstellas
Contacts:For MediaCandace JohnsonAssociate Director, Corporate
Affairs224-205-5735candace.johnson@astellas.comorFor InvestorsSo
SekineSenior Manager, Investor
Relations847-224-9557sou.sekine@astellas.com
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