BOTHELL, Wash., and
TOKYO, Dec.
2, 2019 /PRNewswire/ -- Seattle Genetics,
Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503,
President and CEO: Kenji Yasukawa,
Ph.D., "Astellas"), today announced a clinical collaboration
agreement with Merck, known as MSD outside the United States and Canada through a subsidiary, to evaluate the
combination of Seattle Genetics' and Astellas' antibody-drug
conjugate (ADC) enfortumab vedotin and Merck's anti-PD-1 therapy,
KEYTRUDA® (pembrolizumab), in patients with
previously untreated metastatic urothelial cancer.
Under the terms of the agreement, the three companies will
conduct and fund a global, registrational phase 3 clinical trial to
be led by Seattle Genetics. The trial will be designed to evaluate
the efficacy of the combination of enfortumab vedotin and
pembrolizumab in patients with previously untreated locally
advanced or metastatic urothelial cancer. The companies are working
in consultation with regulatory authorities to finalize the trial
design and currently plan to initiate the trial in the first half
of 2020.
"We look forward to initiating a randomized phase 3 trial in
patients with previously untreated locally advanced or metastatic
urothelial cancer," said Roger
Dansey, M.D., Chief Medical Officer at Seattle Genetics.
"Recent data from a phase 1b trial of
enfortumab vedotin in combination with pembrolizumab showed
evidence of clinical activity leading to the development of this
phase 3 trial."
"An unmet medical need exists for previously untreated patients
with metastatic urothelial cancer, and we are committed to studying
enfortumab vedotin in combination with other agents in different
stages of urothelial cancer," said Andrew
Krivoshik, M.D., Ph.D., Senior Vice President and Oncology
Therapeutic Area Head at Astellas. "We look forward to further
evaluating enfortumab vedotin and pembrolizumab in this high unmet
need patient population."
Enfortumab vedotin is currently under review by the U.S. Food
and Drug Administration (FDA) for the treatment of adult patients
with locally advanced or metastatic urothelial cancer who have
received a PD-1/L1 inhibitor and who have received a
platinum-containing chemotherapy in the neoadjuvant/adjuvant,
locally advanced or metastatic setting. The PDUFA action date is
March 15, 2020.
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme Corp., a subsidiary of Merck & Co., Inc.,
Kenilworth, NJ, USA.
About Urothelial Cancer
Urothelial cancer is the most
common type of bladder cancer (90 percent of cases).1 In
2019, more than 80,000 people will be diagnosed with bladder cancer
in the United States. Globally,
approximately 549,000 people were diagnosed with bladder cancer
last year, and there were approximately 200,000 deaths
worldwide.2
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 that is expressed on
many solid tumors, and that has been identified as an ADC target by
Astellas.
The safety and efficacy of enfortumab vedotin are under
investigation and have not been established. There is no guarantee
that the agent will receive regulatory approval or become
commercially available for the uses being investigated.
About Seattle Genetics
Seattle Genetics, Inc. is an
emerging multi-product, global biotechnology company that develops
and commercializes transformative therapies targeting cancer to
make a meaningful difference in people's lives. The company is
headquartered in Bothell,
Washington, and has a European office in Switzerland. For more information on our
robust pipeline, visit 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. For more information, please visit our website at
https://www.astellas.com/en
About the Astellas and Seattle Genetics Collaboration
Seattle Genetics and Astellas are co-developing enfortumab vedotin
under a collaboration that was entered into in 2007 and expanded in
2009. Under the collaboration, the companies are sharing costs and
profits on a 50:50 basis worldwide.
Seattle Genetics Forward Looking Statements
Certain
statements made in this press release are forward looking, such as
those, among others, relating to clinical development
plans including the proposed phase 3 trial of enfortumab vedotin in
combination with pembrolizumab as a potential treatment option
for previously untreated metastatic urothelial cancer; the
therapeutic potential of enfortumab vedotin including its possible
safety, efficacy, and therapeutic uses, including in previously
untreated metastatic urothelial cancer, and the potential FDA
approval of enfortumab vedotin for the treatment of patients with
locally advanced or metastatic urothelial cancer who have received
a PD-1/L1 inhibitor and who have received a platinum-containing
chemotherapy in the neoadjuvant/adjuvant, locally advanced or
metastatic setting. 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
possibility that ongoing and subsequent clinical trials of
enfortumab vedotin, including the proposed phase 3 trial of
enfortumab vedotin in combination with pembrolizumab, may fail to
establish sufficient efficacy; that adverse events or safety
signals may occur; that adverse regulatory actions or other
setbacks could occur as enfortumab vedotin advances in clinical
trials even after promising results in earlier clinical trials; and
that the Biologics License Application submission and any future
potential supplemental Biologics License Application submissions
for enfortumab vedotin may not be approved by the FDA in a timely
manner or at all or with the requested label(s). 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
September 30, 2019 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, except as required by law.
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.
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.
_____________________________
1 American Society of Clinical Oncology. Bladder
Cancer: Introduction (05-2019).
https://www.cancer.net/cancer-types/bladder-cancer/introduction.
2 International Agency for Research on Cancer.
Cancer tomorrow: bladder. http://gco.iarc.fr/tomorrow.
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