Seattle Genetics, Inc. (NASDAQ: SGEN) and Astellas Pharma Inc.
(TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”)
today announced that the U.S. Food and Drug Administration (FDA)
has granted Breakthrough Therapy Designation to enfortumab vedotin,
an antibody-drug conjugate (ADC), for patients with locally
advanced or metastatic urothelial cancer who were previously
treated with checkpoint inhibitors (CPI).
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Breakthrough Therapy Designation is a process designed to
expedite the development and review of drugs that are intended to
treat a serious or life-threatening condition. It is based upon
preliminary clinical evidence indicating that the drug may
demonstrate substantial improvement over available therapy on a
clinically significant endpoint(s).
“The FDA Breakthrough Therapy Designation underscores the
potential of enfortumab vedotin as a meaningful treatment for
patients with locally advanced or metastatic urothelial cancer.
Further, it supports our rapid development plans for this ADC,
including the ongoing pivotal study in this patient population,”
said Robert Lechleider, M.D., Senior Vice President, Clinical
Development at Seattle Genetics. “Seattle Genetics is an emerging
multi-product oncology company, advancing a robust pipeline with
the goal of improving outcomes for cancer patients. Enfortumab
vedotin is at the forefront of our late-stage clinical pipeline,
and we are working closely with our partner and the FDA to bring
this potential new treatment to patients as quickly as
possible.”
“Achieving Breakthrough Therapy Designation for enfortumab
vedotin is another step forward in our goal to bring an additional
treatment option to patients who need it most,” said Steven Benner,
M.D., Senior Vice President and Global Therapeutic Area Head,
Oncology Development at Astellas. “With the enfortumab vedotin
registrational phase 2 trial and CPI-combination trial actively
underway, Astellas looks forward to expanding development of
enfortumab vedotin and its oncology pipeline, including treatments
that would target some of the hardest-to-treat cancers.”
The Breakthrough Therapy Designation was granted based on
interim results from the phase 1 study examining enfortumab vedotin
as monotherapy treatment for patients with metastatic urothelial
cancer who were previously treated with CPIs. Enfortumab vedotin is
being studied in a pivotal clinical trial, EV-201 (NCT03219333), as
monotherapy in this patient setting and in an early-phase clinical
trial in combination with CPI therapy, EV-103 (NCT03288545). The
companies are also evaluating enfortumab vedotin in other solid
tumors, including ovarian and non-small cell lung carcinoma.
More information about the ongoing trials can be found at
www.clinicaltrials.gov.
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.
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
targeted 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 Annual
Report on Form 10-K for the year ended December 31, 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.
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.
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 GeneticsFor MediaKavita V. Shah,
425-527-4188Associate Director, Corporate
Communicationskshah@seagen.comorFor InvestorsPeggy Pinkston,
425-527-4160Vice President, Investor
Relationsppinkston@seagen.comorAstellasFor MediaCandace
Johnson, 224-205-5735Associate Director, Corporate
Affairscandace.johnson@astellas.comorFor InvestorsShin Okubo,
+81-3-3244-3202Executive Director, Investor
Relationsshin.ohkubo@astellas.com