-Updated Data from Phase 1 EV-101 Study
Highlighted in ASCO 2018 Oral Presentation Support Rapid
Development Program and Ongoing Pivotal Study-
Seattle Genetics, Inc. (Nasdaq: SGEN) and Astellas Pharma Inc.
(TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”)
today announced the presentation of updated phase 1 data of
enfortumab vedotin, an investigational antibody-drug conjugate
(ADC), at the American Society of Clinical Oncology (ASCO) 2018
Annual Meeting in Chicago. In this phase 1 study (EV-101),
enfortumab vedotin was evaluated as monotherapy for patients with
metastatic urothelial cancer including patients who previously
received a checkpoint inhibitor. This phase 1 study is part of a
broader program focused on investigating enfortumab vedotin in both
monotherapy and in combination with a checkpoint inhibitor for
locally advanced or metastatic urothelial cancer.
“Many patients with locally advanced or metastatic urothelial
cancer previously treated with checkpoint inhibitors have a poor
prognosis and limited subsequent treatment options,” said Jonathan
E. Rosenberg, M.D., medical oncologist at Memorial Sloan Kettering
Cancer Center and presenter of the updated phase 1 data at ASCO.
“Data from the ongoing study support the potential of enfortumab
vedotin in locally advanced or metastatic urothelial cancer, based
on the objective response rate and preliminary estimates of
survival.”
Robert Lechleider, M.D., Senior Vice President, Clinical
Development at Seattle Genetics added, “These ASCO data from the
phase 1 study of enfortumab vedotin further support its
Breakthrough Therapy Designation from the FDA, and the rationale
for our ongoing pivotal trial, EV-201. We look forward to
completing enrollment of the EV-201 pivotal trial for patients with
metastatic urothelial cancer who have received both a
platinum-based therapy and a checkpoint inhibitor. Positive data in
this patient subgroup may represent a potential expedited
registration pathway.”
“We are encouraged by these updated data for enfortumab vedotin,
which further support the rapid expansion of a comprehensive
clinical trial program and the registrational study that is already
underway in metastatic urothelial cancer,” said Steven Benner,
M.D., Senior Vice President and Global Therapeutic Area Head,
Oncology Development, Astellas. “We look forward to working closely
with our partner, Seattle Genetics, as we continue to evaluate
enfortumab vedotin for patients with metastatic urothelial
cancer.”
The following updated results were presented by Dr.
Rosenberg:
Updated Results from the Enfortumab Vedotin Phase 1 (EV-101)
Study in Patients with Metastatic Urothelial Cancer: (Abstract
#4504, oral abstract session on Sunday, June 3 from 9:12-9:24 a.m.
CT)
Study Design
- A total of 112 patients with metastatic
urothelial cancer treated with 1 or more prior chemotherapy or who
were ineligible for cisplatin received a 30-minute infusion of
enfortumab vedotin at 1.25 mg/kg on day 1, 8 and 15 of each 28-day
cycle.
- Sixty-three percent of patients had
received 2 or more prior therapies in the metastatic setting.
- The primary objective of the study was
tolerability. A secondary objective was antitumor activity, which
was assessed by investigators every 8 weeks.
Study Results
- Of 112 evaluable patients, confirmed
complete responses were observed in 4 patients and confirmed
partial responses were observed in 41 patients, with an overall
response rate of 41 percent.
- The most commonly reported
treatment-related adverse event was All Grade fatigue (54 percent).
Anemia (8 percent), hyponatremia (7 percent), urinary tract
infection (7 percent) and hyperglycemia (6 percent) were the most
common ≥ Grade 3 AEs.1 Four patients experienced a fatal
treatment-related adverse event (respiratory failure, urinary tract
obstruction, diabetic ketoacidosis, multi-organ failure).
- Additionally, the ORR in the 89
patients with prior checkpoint inhibitor therapy was 40 percent, 44
percent in the 23 patients who had not been treated with a
checkpoint inhibitor, and 39 percent in the 33 patients with liver
metastases.
- For all enrolled patients, the interim
median overall survival was 13.6 months, the overall median
duration of response was 5.75 months and the median
progression-free survival was 5.4 months.
EV-201 Study: A Single-Arm, Open-Label, Multicenter Study of
Enfortumab Vedotin for Treatment of Patients with Locally Advanced
or Metastatic Urothelial Cancer Who Previously Received Immune
Checkpoint Inhibitor Therapy (Abstract #TPS4590, poster session on
Saturday, June 2 from 8:00-11:30 a.m. CT)
In addition, the EV-201 trial in progress poster was presented
at the meeting. EV-201 is an ongoing single-arm, single-agent
pivotal phase 2 clinical trial of enfortumab vedotin for patients
with locally advanced or metastatic urothelial cancer who have been
previously treated with checkpoint inhibitor therapy, including
those who had also been treated with a platinum chemotherapy and
those who were platinum naive.
More information about the enfortumab vedotin clinical trials
can be found at https://www.clinicaltrials.gov.
About Urothelial Cancer
According to the American Cancer Society, urothelial cancer,
also known as transitional cell carcinoma (TCC), is the most common
type of bladder cancer1 (90 percent of cases). Approximately 81,000
people in the U.S. are anticipated to be diagnosed with bladder
cancer during 2018. Bladder cancer is the fourth most common cancer
in men, but is less common in women. Outcomes are poor for people
diagnosed with metastatic disease, with a five-year survival rate
of 4.8 percent.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 identified as an ADC target by
Astellas, which is expressed on many solid tumors.
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. ADCETRIS® (brentuximab vedotin)
utilizes the company’s industry-leading antibody-drug conjugate
(ADC) technology and is currently approved for the treatment of
multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company
has established a pipeline of novel targeted therapies at various
stages of clinical testing, including three in ongoing or planned
pivotal trials for solid tumors. Enfortumab vedotin for metastatic
urothelial cancer and tisotumab vedotin for metastatic cervical
cancer utilize our proprietary ADC technology. Tucatinib, a small
molecule tyrosine kinase inhibitor, is in a pivotal trial for
HER2-positive metastatic breast cancer. In addition, we are
leveraging our expertise in empowered antibodies to build a
portfolio of proprietary immuno-oncology agents in clinical trials
targeting hematologic malignancies and solid tumors. 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 Seattle Genetics and Astellas 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, the risk of adverse events or
safety signals, and the possibility of adverse regulatory actions
as enfortumab vedotin advance 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 Quarterly Report on Form 10-Q for the quarter ended March
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.
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.
1 American Cancer Society. What is bladder cancer?
https://www.cancer.org/cancer/bladder-cancer/about/what-is-bladder-cancer.html.
Accessed 05-08-2018.2 National Cancer Institute. Surveillance,
Epidemiology, and End Results Program. Cancer stat facts: bladder
cancer. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed
05-08-2018.
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Seattle GeneticsFor MediaMonique Greer, 425-527-4641Vice
President, Corporate Communicationsmgreer@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.okubo@astellas.com