New England Journal of Medicine Publishes Results from Phase 3 AFFIRM Trial of Enzalutamide
-Study appears in August 15 online edition-
San Francisco, CA and Tokyo – August 15, 2012 –
Medivation, Inc. (Nasdaq: MDVN) and Astellas Pharma Inc. (TSE:
4503) today announced the publication in the New England Journal of
Medicine of the results from the Phase 3 AFFIRM trial, an
international, randomized, double-blind, placebo-controlled
clinical study of enzalutamide (formerly MDV3100) in men with
metastatic castration-resistant prostate cancer who have been
previously treated with docetaxel-based chemotherapy. The paper,
"Increased Survival with Enzalutamide in Prostate Cancer After
Chemotherapy," appears in the August 15 online issue of the
Journal.
"The AFFIRM data represent an important body of clinical
evidence on enzalutamide, a novel oral androgen receptor signaling
inhibitor, as a potential new treatment that can prolong the lives
of men with advanced prostate cancer. The achievement underlines
the importance of integrating clinical observations and basic
research to significantly improve patient outcomes and bring
therapies to patients faster. It is extremely gratifying to share
these results with the
medical community," said Howard I. Scher, M.D., chief,
Genitourinary Oncology Service at Memorial-Sloan Kettering Cancer
Center, the co-principal investigator and lead author of the AFFIRM
study paper.
In the AFFIRM trial, the data showed that enzalutamide exhibited a
statistically significant benefit in overall survival compared to
placebo. Men treated with enzalutamide had a median overall
survival of 18.4 months (95% confidence interval, 17.3 to not yet
reached) compared to 13.6 months (95% confidence interval 11.3
-15.8) for men treated with placebo (hazard ratio 0.63;
p<0.0001), representing a 37 percent reduction in the risk of
death.
In the Phase 3 AFFIRM trial three most common side effects observed more frequently in enzalutamide as compared with placebo-treated patients included fatigue, diarrhea and hot flush. Seizure was reported in less than 1% of enzalutamide-treated patients. Serious adverse events were lower in the enzalutamide group than in the placebo group.
About Enzalutamide (formerly MDV3100)
Enzalutamide is an oral, once-daily investigational agent that is
an androgen receptor signaling inhibitor. Enzalutamide inhibits
androgen receptor signaling in three distinct ways: it inhibits 1)
testosterone binding to androgen receptors; 2) nuclear
translocation of androgen receptors; and 3) DNA binding and
activation by androgen receptors. Medivation and Astellas announced
on July 24, 2012 that the U.S. Food and Drug Administration
accepted the enzalutamide New Drug Application filing for review
and granted Priority Review Designation.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the
rapid development of novel 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 www.medivation.com.
About Astellas Pharma Inc.
Astellas Pharma Inc. is a pharmaceutical company dedicated to
improving the health of people around the world through provision
of innovative and reliable pharmaceuticals. The organization is
committed to becoming a global category leader in Oncology, and has
several oncology compounds in development in addition to
enzalutamide. For more information on Astellas Pharma Inc., please
visit our website at www.astellas.com/en.
Scher, HI, et al. Increased Survival with Enzalutamide in
Prostate Cancer After Chemotherapy.
New Engl J Med. 2012; 367.
Medivation Contacts: Astellas Contacts:
Patrick Machado Jenny Kite
Chief Business & Financial Officer Corporate
Communications
(415) 829-4101 (847) 682-4530
Anne Bowdidge Mike Beyer
Senior Director, Investor Relations Sam Brown, Inc (media for both
companies)
(650) 218-6900 (773) 463-4211
Posted: August 2012
