-Study appears in January 13, 2016
online edition-
Astellas Pharma Europe Ltd., a subsidiary of Tokyo-based
Astellas Pharma Inc. (TSE:4503), today announced that results from
the Phase 2 TERRAIN trial of XTANDITM▼ (enzalutamide) compared to
bicalutamide in metastatic castration-resistant prostate cancer
(mCRPC) were published in the Lancet Oncology. The article, titled,
“Efficacy and Safety of Enzalutamide Versus Bicalutamide for
Patients with Metastatic Prostate Cancer (TERRAIN): A Randomised,
Double-Blind, Phase 2 Study,” appears in the January 13, 2016
online issue, lead author Dr Neal D Shore. The article will be
published in a future print issue of the journal.1
The TERRAIN study achieved its primary endpoint demonstrating a
statistically significant increase in progression-free survival
(PFS) for enzalutamide compared to bicalutamide (Hazard Ratio =
0.44; 95% Confidence Interval, 0.34-0.57; p<0.0001). Median PFS
was 15.7 months in the enzalutamide group compared to 5.8 months in
the bicalutamide group. The observed adverse event profile in
TERRAIN appeared consistent with that from Phase 3 enzalutamide
trials.
“Now that these data are published, more healthcare
professionals will be able to see for themselves the promise of
enzalutamide versus bicalutamide in metastatic castration-resistant
prostate cancer,” said Professor Axel Heidenreich, M.D., Ph.D.,
Professor and Director, Department of Urology, University Hospital,
Cologne, Germany. “Enzalutamide was superior to bicalutamide in all
primary and secondary endpoints demonstrating the drug’s
oncological efficacy. Despite the fact that patients were treated
with enzalutamide twice as long as with bicalutamide, no
significant interference with quality of life was observed. These
findings may have significant implications for the clinical
practice.”
The median time on treatment in TERRAIN was 11.7 months in the
enzalutamide group versus 5.8 months in the bicalutamide
group. Serious adverse events were reported in 31% of
enzalutamide-treated patients and 23% of bicalutamide-treated
patients. Individual Grade 3 or higher adverse events largely
occurred at a similar rate (<1% difference) between treatment
groups, with the exception of hypertension (7.1% vs. 4.2%) and back
pain (2.7% vs. 1.6%), which occurred more frequently in the
enzalutamide treatment group. Grade 3 or higher cardiac events were
reported in 5% of enzalutamide-treated patients versus 2% of
bicalutamide-treated patients. The majority of patients with these
events in both treatment groups had cardiovascular risk factors at
baseline. Two seizures were reported in the enzalutamide group and
one in the bicalutamide group. The most common side effects
occurring during treatment and more common in the
enzalutamide-treated versus bicalutamide-treated patients included
fatigue, back pain, hot flush, hypertension, diarrhoea, weight
decrease and pain in extremity.
“TERRAIN is the first head-to-head trial comparing enzalutamide
with bicalutamide that evaluated both the efficacy and safety of
these agents in the treatment of men with mCRPC,” said Claire Thom,
Pharm D., Senior Vice President and Oncology Therapeutic Head,
Astellas. “We believe these findings add to the already robust body
of data for enzalutamide and appear consistent with results across
multiple trials and stages of advanced prostate cancer that have
been studied. We are pleased Lancet Oncology has chosen to publish
these important results.”
- Ends -
Notes to editors
About the TERRAIN trial
The Phase 2 TERRAIN trial enrolled 375 patients in North America
and Europe. The trial enrolled patients with metastatic prostate
cancer whose disease progressed despite treatment with a
luteinising hormone-releasing hormone (LHRH) analogue therapy or
following surgical castration. The primary endpoint of the trial
was PFS, defined as time from randomisation to centrally confirmed
radiographic progression, skeletal related event, initiation of new
anti-neoplastic therapy or death, whichever occurred first. The
trial was designed to evaluate enzalutamide at a dose of 160 mg
taken orally once daily versus bicalutamide at a dose of 50 mg
taken once daily, the approved dose in combination with an LHRH
analogue.
About XTANDI™ (enzalutamide)
Enzalutamide is a novel, oral, once-daily androgen receptor
signaling inhibitor. Enzalutamide directly targets the androgen
receptors (AR) and exerts its effects on all three steps of AR
signaling pathway:
- Blocks androgen binding2
- Androgen binding induces a
conformational change that triggers activation of the
receptor3
- Prevents nuclear translocation1
- Transit of the AR to the nucleus is an
essential step in AR-mediated gene regulation2
- Impairs DNA binding1
- Binding of the AR to the DNA is
essential for modulation of gene expression2
Enzalutamide was first approved by the European Commission in June
2013 for the treatment of adult men with mCRPC whose disease has
progressed on or after docetaxel therapy.4 Enzalutamide is now
approved in Europe for the treatment of adult men with metastatic
castration-resistant prostate cancer who are asymptomatic or mildly
symptomatic after failure of androgen deprivation therapy in whom
chemotherapy is not yet clinically indicated.3
Important Safety Information for XTANDI™
(enzalutamide)
For important Safety Information for enzalutamide please see the
full Summary of Product Characteristics at:
http://www.medicines.org.uk/emc/medicine/27912/SPC/Xtandi+40mg+soft+capsules/.
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.
About Astellas Pharma Europe Ltd.
Astellas Pharma Europe Ltd. operates in 40 countries across
Europe, the Middle East and Africa, and is the regional business of
Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical
company dedicated to improving the health of people around the
world through the provision of innovative and reliable
pharmaceuticals. The organisation’s focus is to deliver outstanding
R&D and marketing to continue growing in the world
pharmaceutical market. Astellas’ presence in Europe also includes
an R&D site and three manufacturing plants. The company employs
approximately 4,350 staff across these countries.
About the Medivation/Astellas Collaboration
In October 2009, Medivation (NASDAQ: MDVN) and Astellas (TSE:
4503) entered into a global agreement to jointly develop and
commercialise enzalutamide. The companies are collaborating on a
comprehensive development programme that includes studies to
develop enzalutamide across the full spectrum of advanced prostate
cancer as well as advanced breast cancer. The companies jointly
commercialise 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.
ENZ/15/0049/EU
References
1 Shore ND, Chowdhury S, Villers A, et al. Efficacy and safety
of enzalutamide versus bicalutamide for patients with metastatic
prostate cancer (TERRAIN): a randomised, double-blind, phase 2
study. Lancet Oncol 2016; published online January 13.
http://dx.doi.org/10.1016/S1470-2045(15)00518-5
2 Tran C, et al. Development of a second-generation antiandrogen
for treatment of advanced prostate cancer. Science 2009;
324:787-790
3 Hu R, Denmeade SR and Luo J. Molecular processes leading to
aberrant androgen receptor signaling and castration resistance in
prostate cancer. Expert Rev Endocrinol Metab 2010; 5 (5):
753–764
4 European Medicines Agency. XTANDI (enzalutamide). Summary of
Product Characteristics, 2015
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Astellas Corporate CommunicationsAJ Kenneally+44 (0)7775
113515AJ.Kenneally@astellas.comorRed Door UnlimitedSarah
Aldrige+44 (0) 785 259 2971saldridge@reddoorunlimited.com
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