TOKYO, May 29, 2020 /PRNewswire/ -- Astellas Pharma Inc.
(TSE: 4503, President and CEO: Kenji
Yasukawa, Ph.D., "Astellas") today announced that the Japan
Ministry of Health, Labour and Welfare (MHLW) has approved
XTANDI® (enzalutamide), an oral androgen receptor
signaling inhibitor, for the treatment of prostate cancer patients
with distant metastasis. With this approval, XTANDI is now
indicated for the treatment of metastatic hormone-sensitive
prostate cancer (mHSPC), a form of prostate cancer that has spread
to other parts of the body and still responds to a medical or
surgical treatment that lowers
testosterone.1,2 This is in addition to an existing
indication for castration-resistant prostate
cancer (CRPC).
The approval for mHSPC is based on results from the ARCHES
triali, a randomized multi-national Phase 3 study which
evaluated enzalutamide plus androgen deprivation therapy (ADT)
versus placebo plus ADT in 1,150 men with mHSPC and met its primary
endpoint of radiographic progression-free survival
(rPFS).3 It is also supported by data from the
ENZAMET trialii, an overseas Phase 3 study evaluating
enzalutamide plus ADT versus ADT plus a standard nonsteroidal
antiandrogen therapy (bicalutamide, nilutamide or flutamide) in men
with mHSPC.4
"Enzalutamide with androgen deprivation therapy led to a
significant delay in the risk of progression of metastatic disease
or death, and this delay was associated with maintained quality of
life and a reduced need for subsequent therapies over time.
These endpoints are all critically important to men with metastatic
prostate cancer," said Andrew
Armstrong, M.D., Professor of Medicine, Surgery,
Pharmacology and Cancer Biology, Director of Research in the Duke
Cancer Institute's Center for Prostate and Urologic Cancers and
lead investigator of the ARCHES trial. "The research
supporting the approval provides compelling evidence to consider
enzalutamide as a treatment option for men with mHSPC."
Data from the ARCHES trial showed enzalutamide plus ADT
significantly reduced the risk of radiographic progression or death
by 61% versus placebo plus ADT in men with mHSPC.5 The
ENZAMET trial demonstrated a 33% reduction in the risk of death in
men with mHSPC receiving enzalutamide plus ADT compared to those
who took a nonsteroidal antiandrogen therapy plus
ADT.6
The safety analyses of the ARCHES and ENZAMET trials were
generally consistent with the safety profile of enzalutamide in
previous clinical trials in CRPC. In the ARCHES trial, adverse drug
reactions were reported in 53.0% of patients. Major adverse drug
reactions with an incidence of more than 10% were hot flush
(20.5%) and fatigue (14.9%). In the ENZAMET trial, serious
adverse drug reactions were reported in 3.0% of patients. Serious
adverse drug reactions observed in 2 or more patients were seizure
(0.9%), hypertension (0.5%) and fatigue (0.4%).
"Today's MHLW approval of XTANDI marks continued progress to
provide a treatment option to men earlier in their advanced
prostate cancer treatment journey," said Andrew Krivoshik, M.D., Ph.D., Senior Vice
President and Global Therapeutic Area Head, Oncology Development.
"At Astellas, we have made a commitment to fight cancer and
continue to build a robust oncology portfolio to help meet the
needs of patients."
About metastatic Hormone-Sensitive Prostate Cancer
(mHSPC)
In men with prostate cancer, the disease is
considered metastatic once the cancer has spread outside of the
prostate gland to other parts of the body. Men are considered
hormone- (or castration-) sensitive if their disease still responds
to medical or surgical treatment that lowers testosterone.
About the ARCHES trial
The company-sponsored, Phase
3, randomized, multinational, double-blind, placebo-controlled,
ARCHES trial (NCT02677896) enrolled 1,150 patients with mHSPC at
sites in the U.S., Canada,
Europe, South America, and the Asia-Pacific region. Patients in the trial
were randomized to receive enzalutamide 160 mg daily or placebo and
continued on a luteinizing hormone-releasing hormone (LHRH) agonist
or antagonist or had a history of bilateral orchiectomy. The
primary endpoint of the trial was radiographic progression-free
survival (rPFS) assessed by blinded independent central review.
rPFS was defined as the time from randomization to radiographic
disease progression at any time or death within 24 weeks after
study drug discontinuation. Patients were stratified by volume of
disease (low vs high) and prior docetaxel therapy for prostate
cancer (no prior docetaxel, 1-5 cycles, or 6 prior
cycles).3
About the ENZAMET trial
ENZAMET is an overseas Phase 3
study funded by Astellas and sponsored by the University of Sydney with trial sites in
Australia, Canada, Ireland, New
Zealand, UK and U.S. The trial evaluated the potential of
enzalutamide plus androgen deprivation therapy (ADT) versus a
conventional non-steroidal anti androgen (NSAA) plus ADT in 1,125
men with mHSPC. The primary endpoint for the trial is overall
survival (OS; 3-years). Additional details about ENZAMET
(NCT02446405) are available on
www.clinicaltrials.gov.4
About XTANDI® (enzalutamide)
Enzalutamide
is an androgen receptor signaling inhibitor indicated for the
treatment of patients with castration-resistant prostate cancer
(CRPC) and metastatic hormone-sensitive prostate cancer
(mHSPC).
Important Safety Information
For important Safety
Information for enzalutamide please see the Package Insert.
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 Pfizer/Astellas Collaboration
In
October 2009, Medivation, Inc., which
is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered
into a global agreement to jointly develop and commercialize
enzalutamide. The companies jointly commercialize enzalutamide in
the United States and Astellas has
responsibility for manufacturing and all additional regulatory
filings globally, as well as commercializing enzalutamide outside
the United States.
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.
i Referred to as the Multinational Phase
III study in the Japan Package Insert
ii Referred to as the Overseas Phase III study in
the Japan Package Insert
REFERENCES
1 Cancer.net. Prostate Cancer: Types
of Treatment (03-2018).
https://www.cancer.net/cancer-types/prostate-cancer/types-treatment.
Accessed May 2020.
2 American Society of Clinical Oncology.
ASCO Answers: Prostate Cancer (2018).
http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf.
Accessed May 2020.
3 A Study of Enzalutamide Plus Androgen Deprivation
Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic
Hormone Sensitive Prostate Cancer (mHSPC) (ARCHES).
https://clinicaltrials.gov/ct2/show/NCT02677896. Accessed
April 2020.
4 Enzalutamide in First Line Androgen Deprivation
Therapy for Metastatic Prostate Cancer (ENZAMET).
https://clinicaltrials.gov/ct2/show/NCT02446405. Accessed April
2020.
5 Enzalutamide Plus ADT Significantly Reduces Risk of
Progression in Metastatic Hormone-Sensitive Prostate Cancer.
https://www.targetedonc.com/news/enzalutamide-plus-adt-significantly-reduces-risk-of-progression-in-metastatic-hormonesensitive-prostate-cancer.
Accessed April 2020.
6 Current Treatment Options for Metastatic
Hormone-Sensitive Prostate Cancer.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6770296/. Accessed
April 2020.
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