BOTHELL, Wash. and TOKYO, March 28,
2019 /PRNewswire/ -- Seattle Genetics, Inc. (Nasdaq:
SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO:
Kenji Yasukawa, Ph.D., "Astellas")
today announced positive topline results from the first
cohort of patients in a pivotal phase 2 single-arm clinical
trial known as EV-201. The cohort is
evaluating enfortumab vedotin for the treatment of
patients with locally advanced or metastatic urothelial cancer who
have received previous treatment with both platinum-containing
chemotherapy and a PD-1 or PD-L1 inhibitor. Results showed a 44
percent objective response rate (ORR) per blinded independent
central review. The duration of response was consistent with that
recently reported in the previous phase 1 study (EV-101). The
most common treatment-related adverse events included fatigue,
alopecia, decreased appetite, rash and peripheral neuropathy. The
data will be presented at an upcoming medical
meeting.
Enfortumab vedotin is an investigational antibody-drug conjugate
(ADC) that targets Nectin-4, a therapeutic target that is highly
expressed in multiple solid tumors including urothelial cancers.
Based on preliminary results from a phase 1 trial (EV-101),
enfortumab vedotin was granted Breakthrough Therapy designation by
the U.S. Food and Drug Administration (FDA) for patients with
locally advanced or metastatic urothelial cancer whose disease
has progressed during or following treatment with a PD-1 or
PD-L1 inhibitor.
The companies plan to submit a Biologics License Application
(BLA) to the FDA later this year based on the results from the
EV-201 trial (cohort 1). A global, randomized phase 3 clinical
trial (EV-301) is ongoing and intended to support global
registration as well as to serve as the confirmatory randomized
trial for enfortumab vedotin for patients with locally advanced or
metastatic urothelial cancer who have been previously treated with
a platinum-containing chemotherapy and a PD-1 or PD-L1
inhibitor.
"Despite recent approvals of multiple checkpoint inhibitors for
previously treated locally advanced or metastatic urothelial
cancer, there remains a high unmet need for effective treatments
upon progression after initial chemotherapy and immunotherapy,"
said Roger Dansey, M.D., Chief
Medical Officer at Seattle Genetics. "These results
for enfortumab vedotin indicate it may be able to
help patients whose urothelial
cancer progresses following treatment with standard
chemotherapy and a PD-1 or PD-L1 inhibitor."
"After progression on platinum-containing chemotherapy and a
PD-1 or PD-L1 inhibitor, patients with locally advanced or
metastatic urothelial cancer are left with no approved standard of
care treatment options," said Steven
Benner, M.D., Senior Vice President and Global Therapeutic
Area Head, Oncology Development at Astellas. "These data are very
encouraging, and we look forward to discussing the data with
relevant health authorities."
Urothelial cancer is the most common type of bladder cancer (90
percent of cases).1 In 2018, more than 82,000 people
were diagnosed with bladder cancer in the United States.2 Globally,
approximately 549,000 people were diagnosed with bladder cancer
last year, and there were approximately 200,000 deaths
worldwide.3 Approximately 80 percent of people do not
respond to PD-1 or PD-L1 inhibitors after a platinum-containing
therapy has failed as an initial treatment for advanced
disease.4 There are currently no approved therapies for
metastatic urothelial cancer once it has progressed after
chemotherapy and a PD-1 or PD-L1 inhibitor.5
In addition to the ongoing confirmatory phase 3 study intended
to also support global registration, development of enfortumab
vedotin is underway in earlier lines of treatment for locally
advanced or metastatic urothelial cancer, including in newly
diagnosed patients in combination with pembrolizumab and/or
platinum chemotherapy.
About the EV-201 Trial
EV-201 is an ongoing
single-arm, pivotal phase 2 clinical trial of enfortumab vedotin
for patients with locally advanced or metastatic urothelial cancer
who have been previously treated with a PD-1 or PD-L1 inhibitor,
including those who have also been treated with a
platinum-containing chemotherapy (cohort 1) and those who have not
received a platinum-containing chemotherapy and who are ineligible
for cisplatin (cohort 2). The EV-201 phase 2 trial continues to
enroll patients in cohort 2. In cohort 1, 128 patients were
enrolled at multiple centers internationally.6 The
primary endpoint is confirmed objective response rate per blinded
independent central review. Secondary endpoints include assessments
of duration of response, disease control rate, progression-free
survival, overall survival, safety and tolerability. More
information about enfortumab vedotin clinical trials can be found
at clinical trials.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.
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 and 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 Statement
Certain
statements made in this press release are forward looking, such as
those, among others, relating to the companies' expected reporting
of data from cohort 1 of the EV-201 trial in upcoming medical
conferences, and plan to submit a Biologics License Application
(BLA) to the FDA in the near term under FDA's Accelerated Approval
program based on the results of the pivotal EV-201 trial; conduct
of a comprehensive clinical development program for enfortumab
vedotin, which includes an ongoing randomized phase 3 confirmatory
trial (EV-301) intended to support global registration in locally
advanced or metastatic urothelial cancer; and 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 that the data from
EV-201 may not be selected for publication at medical conferences;
the possibility of delays in the submission of a BLA to the FDA;
that the data from EV-201 may not be sufficient to support
accelerated approval; and the inability to show sufficient activity
in EV-301 and subsequent clinical trials; the risk of adverse
events or safety signals; and the possibility of adverse regulatory
actions as enfortumab vedotin advances in clinical trials even
after promising results in earlier clinical trials. 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, 2018 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.
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 (10-2017).
https://www.cancer.net/cancer-types/bladder-cancer/introduction.
2 https://gco.iarc.fr/today/data/factsheets/populations/840-united-states-of-america-fact-sheets.pdf.
3 Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre
LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of
incidence and mortality worldwide for 36 cancers in 185 countries.
CA Cancer J Clin. 2018;68(6):394-424.
4 Alhalabi O, Shah AY, Lemke EA, Gao J (2019).
Immune checkpoint inhibitors in urothelial cancer. Oncology
(Williston Park) 33(1): 1108.
5 National Comprehensive Cancer Network. Bladder
Cancer (Version 1.2019).
http://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.
6 Data on file at Seattle Genetics.
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SOURCE Astellas Pharma Inc.