-ADC Combination Study Focuses on First-Line
Treatment-
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-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.
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“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 November 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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Seattle Genetics:For MediaKavita V. Shah,
425-527-4188Associate Director, Corporate
Communicationskshah@seagen.comorFor InvestorsPeggy Pinkston,
425-527-4160Vice President, Investor
Relationsppinkston@seagen.comorAstellas:For MediaCandace
Johnson, 224-205-5735Associate Director, Corporate
Affairscandace.johnson@astellas.comorFor InvestorsShin Okubo,
+81-3-3244-3202Executive Director, Investor
Relationsshin.ohkubo@astellas.com