- Data examining PSA progression with either
enzalutamide or placebo presented alongside other abstracts,
increase the body of evidence showing the benefits of enzalutamide
for men living with prostate cancer -
Astellas Pharma Europe Ltd., a subsidiary of Tokyo-based
Astellas Pharma Inc. (TSE:4503), today announced the presentation
of new data that reaffirms the role of XTANDITM▼ (enzalutamide) in
extending time to prostate specific antigen (PSA) progression in
men with advanced prostate cancer. The data presented today at the
European Society for Medical Oncology Congress (ESMO), held in
Copenhagen, Denmark, from 7-11 October, confirms the efficacy of
enzalutamide vs placebo in Asian men.
Data from a study examining the efficacy and safety of
enzalutamide versus placebo in 409 Asian patients from China, South
Korea, Taiwan and Hong Kong with asymptomatic/mildly symptomatic
progressive advanced prostate cancer following androgen deprivation
therapy (ADT) found that enzalutamide significantly improved time
to PSA progression, compared with placebo (7.46 months vs 2.86
months, respectively (HR* 0.36; 95% CI 0.27**, 0.5; P<0.0001)).1
PSA blood tests are used to monitor the progression of prostate
cancer.2
Secondary end points included overall survival, defined as time
from randomisation to death from any cause, and radiographic
progression free survival (rPFS) defined as the time from
randomisation to radiographic progression or death from any cause.a
Although the median overall survival was not yet reached at the
time of the data cut-off in either treatment arm, enzalutamide
significantly reduced the risk of death (HR 0.35; 95% CI 0.17,
0.70; p=0.0021). At data cut-off, enzalutamide significantly
reduced the risk of rPFS events with 19.6% (41/209) of patients
receiving enzalutamide and 36% (72/200) of patients in the placebo
arm experiencing a rPFS event – i.e, spreading of the cancer. While
slightly more patients treated with enzalutamide reported at least
one treatment-emergent adverse event, enzalutamide was generally
well tolerated in the trial.1 These results are consistent with
data from the pivotal PREVAIL trial, which considered a patient
population with similar clinical characteristics. In the PREVAIL
trial, enzalutamide was found to increase the median overall
survival in asymptomatic or mildly symptomatic patients with
advanced prostate cancer who had not received chemotherapy,
compared with placebo.3
__________________
aWithin 168 days of treatment discontinuation, whichever
occurred first, assessed during the screening, at day 57, 113, 169
and 253 and every subsequent 12 weeks.
Dr Simon Chowdhury, Consultant Medical Oncologist, Guy's and St
Thomas' NHS Foundation Trust, “The findings presented today show
that enzalutamide can increase the time to PSA progression - an
important marker used to monitor disease progression in prostate
cancer - compared with placebo, in Asian men. Historically there
has been a lack of studies considering this group of men and so
these results provide reassurance of enzalutamide’s efficacy and
tolerability across the broad population that we tend to see across
Europe.”
An additional five abstracts focusing on enzalutamide were also
presented today, adding further to the body of data supporting the
safety and efficacy profile of enzalutamide as a treatment option
for advanced prostate cancer.
-Ends-
*Hazard ratio**Confidence interval
Dr Simon Chowdhury was approached by Astellas Pharma Europe Ltd.
to provide a quote for inclusion in this press release.
Notes to Editors
Enzalutamide data presentation details:
- Ye D, Ahn H, Pu Y-S, et al. Efficacy
and safety of enzalutamide (ENZ) vs placebo (PL) in
chemotherapy-naïve patients (pts) with progressive metastatic
castration-resistant prostate cancer (mCRPC) following androgen
deprivation therapy (ADT): an Asian multinational study. Poster
760P; 9 Oct 2016 (Sun); 13:00-14:00; Hall E
- Chowdhury S, Shore N, Saad f, et al.
Fatigue in men with metastatic castration-resistant prostate cancer
treated with enzalutamide: data from randomised clinical trials.
Poster 739P; 9 Oct 2016 (Sun);13:00-14:00;Hall E
- Heidenreich A, Shore N, Villers A, et
al. Prognostic factors in men with metastatic castration-resistant
prostate cancer (mCRPC) treated with enzalutamide (ENZA) or
bicalutamide (BIC) in TERRAIN. Poster 759P; 9 Oct 2016 (Sun);
13:00-14:00; Hall E
- Bryce A, Alumkal J, Armstrong A, et al.
A post hoc analysis of radiographic progression with nonrising
prostate-specific antigen in patients with metastatic
castration-resistant prostate cancer (mCRPC) in the PREVAIL study.
Poster 760P; 9 Oct 2016 (Sun); 13:00-14:00; Hall E
- Stenzl A, Krivoshik A, Baron B, et al.
Efficacy and safety of enzalutamide plus androgen deprivation
therapy vs placebo plus androgen deprivation therapy in men with
metastatic hormone-sensitive prostate cancer: the ongoing ARCHES
trial. Poster 767TiP;9 Oct 2016 (Sun);13:00-14:00; Hall E
- Miller K, Mulders P, Freedland S, et
al. EMBARK: A phase 3, randomized, efficacy and safety study of
enzalutamide plus leuprolide, enzalutamide monotherapy and placebo
plus leuprolide in men with high-risk nonmetastatic prostate cancer
progressing after definitive therapy. Poster 770TiP; 9 Oct 2016
(Sun); 13:00-14:00; Hall E
About PREVAIL
PREVAIL was a Phase 3, randomised, double-blind,
placebo-controlled trial of enzalutamide versus placebo in patients
with mCRPC who had not received chemotherapy.3
About AFFIRM
AFFIRM was a Phase 3, randomised, double-blind,
placebo-controlled study of enzalutamide in patients with mCRPC who
had previously been treated with docetaxel-based chemotherapy.4
About TERRAIN
TERRAIN was a Phase 2, randomised, double-blind, efficacy and
safety study of enzalutamide vs. bicalutamide in patients with
mCRPC.5
About STRIVE
STRIVE was a Phase 2, randomised, double-blind, efficacy and
safety study of enzalutamide versus bicalutamide in patients with
nonmetastatic or metastatic CRPC.6
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 binding7
- Androgen binding induces a
conformational change that triggers activation of the
receptor8
- Prevents nuclear translocation7
- Translocation of the AR to the nucleus
is an essential step in AR-mediated gene regulation8
- Impairs DNA binding7
- Binding of the AR to the DNA is
essential for modulation of gene expression8
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.9 Enzalutamide is also
approved in Europe for the treatment of adult men with mCRPC who
are asymptomatic or mildly symptomatic after failure of androgen
deprivation therapy in whom chemotherapy is not yet clinically
indicated.9
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 prioritised 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 commercialising enzalutamide outside
the United States.
References__________________________
1Ye D, Ahn H, Pu Y-S, et al. Efficacy and safety of enzalutamide
(ENZ) vs placebo (PL) in chemotherapy-naïve patients (pts) with
progressive metastatic castration-resistant prostate cancer (mCRPC)
following androgen deprivation therapy (ADT): an Asian
multinational study. Poster 760P; 9 Oct 2016 (Sun); 13:00-14:00;
Hall E
2Cancer Research UK. Prostate Cancer Tests. Available at:
http://www.cancerresearchuk.org/about-cancer/type/prostate-cancer/diagnosis/prostate-cancer-tests.
[Accessed October 2016]
3Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in
metastatic prostate cancer before chemotherapy. N Engl J Med 2014;
371:424-433
4Scher HI, Fizazi K, Saad F, et al. Increased Survival with
Enzalutamide in Prostate Cancer after Chemotherapy. N Eng J Med
2012; 367:1187-1197
5Shore 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 Onc 2016; 17(2):p153–163
6Penson DF, Armstrong AJ, Concepcion R, et al. Enzalutamide
Versus Bicalutamide in Castration-Resistant Prostate Cancer: The
STRIVE Trial. J Clin Oncol 2016; 34(18): 2098-2106
7Tran C, et al. Development of a second-generation antiandrogen
for treatment of advanced prostate cancer. Science 2009;
324:787-790
8Hu 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
9European Medicines Agency. XTANDI (enzalutamide). Summary of
Product Characteristics, 2016
ENZ/16/0026/APELOctober 2016
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version on businesswire.com: http://www.businesswire.com/news/home/20161009005021/en/
Astellas Corporate CommunicationsAJ Knowles, +44 (0)7775
113515AJ.Knowles@astellas.comorRed Door UnlimitedRoss Taylor, +44
(0) 7768 228911rtaylor@reddoorunlimited.com
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