CHERTSEY, England, March 19,
2015 /PRNewswire/ --
Astellas Pharma Europe Ltd. and Medivation, Inc. announced that
two enzalutamide abstracts will be presented at the annual European
Association of Urology (EAU) Congress on March 24, 2015 in Madrid, Spain.
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The following abstracts will be presented during a late-breaking
news plenary session:
Title: Enzalutamide in men with chemotherapy-naïve
metastatic castration-resistant prostate cancer (mCRPC): Final
overall survival analysis of the phase 3 PREVAIL study
Presenter: Bertrand
Tombal, M.D., Ph.D., professor and chairman, Department of
Urology, Universite catholique de Louvain, Cliniques universitaires
Saint-Luc, Brussels, Belgium
- Session Date/Time: Tuesday, March
24, 10:20 AM - 10:30 AM
CEST
- Location: eURO Auditorium
Title: A randomized, double-blind, phase 2,
efficacy and safety study of enzalutamide vs. bicalutamide in
metastatic castration-resistant prostate cancer: TERRAIN trial
Presenter: Axel
Heidenreich, M.D., Ph.D., professor and director, Department
of Urology, University hospital, Aachen, Germany
- Session Date/Time: Tuesday, March
24, 10:35 AM - 10:45 AM
CEST
- Location: eURO Auditorium
About the PREVAIL
Trial[1]
The Phase 3 PREVAIL trial, a randomised, double-blind,
placebo-controlled, multi-national trial, enrolled 1,717 patients
at sites in the United States,
Canada, Europe, Australia, Russia, Israel and Asia, including Japan. The trial enrolled patients with
chemotherapy-naïve metastatic prostate cancer, who were
asymptomatic or mildly symptomatic and whose disease progressed on
androgen deprivation therapy (i.e., a luteinising hormone-releasing
hormone (LHRH) therapy or after bilateral orchiectomy). The
co-primary endpoints of the trial were overall survival and
radiographic progression-free survival. The trial was designed to
evaluate enzalutamide at a dose of 160 mg taken orally once daily
versus placebo.
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 LHRH analogue therapy or following surgical
castration. The primary endpoint of the trial was progression-free
survival, defined as time from randomisation to centrally confirmed
radiographic progression, skeletal related event, initiation of new
anti-neoplastic therapy or death, whichever occurs first. The trial
was designed to evaluate enzalutamide at a dose of 160 mg taken
once daily versus bicalutamide at a dose of 50 mg taken once daily,
the approved dose in combination with a LHRH analogue.
About
XTANDI™ (enzalutamide)
Enzalutamide is a novel, oral, once-daily androgen receptor
signalling inhibitor. Enzalutamide directly targets the androgen
receptors (AR) and exerts its effects on all three steps of AR
signalling pathway:
- Blocks androgen binding[2]
- Androgen binding induces a conformational change that triggers
activation of the receptor[3]
- Prevents nuclear
translocation[2]
- Transit of the AR to the nucleus is an essential step in
AR-mediated gene
regulation[3]
- Impairs DNA binding[2]
- Binding of the AR to the DNA is essential for modulation of
gene expression[3]
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.[4]
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 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. For more
information about Astellas Pharma Europe Ltd., please visit
http://www.astellas.eu.
About Medivation Inc.
Medivation, Inc. is a biopharmaceutical company focused on the
rapid development of medically innovative therapies to treat
serious diseases for which there are limited treatment options.
Medivation aims to transform the treatment of these diseases and
offer hope to critically ill patients and their families. For more
information, please visit us at http://www.medivation.com.
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 commercialising enzalutamide outside
the United States.
1. Beer TM, et al. Enzalutamide in Metastatic Prostate Cancer
before Chemotherapy. N Engl J Med 2014; DOI:
10.1056/NEJMoa1405095
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