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Enzalutamide Data, Including Additional Results From the PREVAIL Trial, to Be Presented at Upcoming ASCO Annual Meeting

Eight Abstracts Will Highlight Enzalutamide Studies in Prostate and Breast Cancers

SAN FRANCISCO, CA and NORTHBROOK, IL -- (Marketwired) -- 05/14/14 -- Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (TSE: 4503) announced that eight enzalutamide abstracts will be presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30-June 3 in Chicago.

The following abstract will be presented during an oral presentation:

Title: (Abstract 5007) Primary, secondary, and quality-of-life endpoint results from PREVAIL, a phase 3 study of enzalutamide in men with metastatic castration resistant prostate cancer (mCRPC).

Presenter: Andrew J. Armstrong, MD, ScM, FACP

  • Session Date/Time: Sunday, June 1, 10:24 AM - 10:36 AM
  • Session Detail: North Hall B1

Seven additional enzalutamide abstracts will be presented during General Poster Sessions.

  • (Abstract 5054) Sensitivity analyses for radiographic progression-free survival (rPFS): results from the phase 3 PREVAIL trial comparing enzalutamide to placebo (Poster Board #183, 1:15-5:00 PM, Monday, June 2, South Hall A2)
  • (Abstract 5051) Safety results of the enzalutamide expanded access program in the United States and Canada for patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel (Poster Board #180, 1:15-5:00 PM, Monday, June 2, South Hall A2)
  • (Abstract TPS5094) PROSPER: A phase 3 study of enzalutamide in nonmetastatic (M0) castration-resistant prostate cancer (CRPC) patients. (Poster Board #223A, 1:15-5:00 PM, Monday, June 2, South Hall A2)
  • (Abstract 5068) Enzalutamide monotherapy: 1-year extended follow-up of a Phase 2 study in hormone-naïve prostate cancer patients (Poster Board #197, 1:15-5:00 PM, Monday, June 2, South Hall A2)
  • (Abstract 545) Enzalutamide plus exemestane: a pilot study to assess safety, pharmacokinetics, and effects on circulating estrogens in women with advanced hormone-positive breast cancer (Poster Board #9, 8:00-11:45 AM, Monday, June 2, South Hall A2)
  • (Abstract TPS1144) A phase 2 single-arm study of the clinical activity and safety of enzalutamide in patients with advanced androgen receptor-positive, triple-negative breast cancer (Poster Board #232A, 8:00-11:45 AM, Monday, June 2, South Hall A2)
  • (Abstract TPS653) A phase 2 randomized, double-blind, placebo-controlled multicenter trial evaluating the efficacy and safety of enzalutamide in combination with exemestane in estrogen or progesterone receptor-positive and HER2 normal advanced breast cancer (Poster Board #116B, 8:00-11:45 AM, Monday, June 2, South Hall A2)

Enzalutamide Mechanism of Action
Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. Enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA.

About XTANDI® (enzalutamide) capsules
XTANDI was approved by the FDA on August 31, 2012 and is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel.

Important Safety Information for XTANDI (from the approved prescribing information)
Contraindications - XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant.

Warnings and Precautions - In the randomized clinical trial, seizure occurred in 0.9% of patients on XTANDI. No patients on the placebo arm experienced seizure. Patients experiencing a seizure were permanently discontinued from therapy. All seizures resolved. Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizure were excluded from the clinical trial. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others.

Adverse Reactions - The most common adverse drug reactions (≥ 5%) reported in patients receiving XTANDI in the randomized clinical trial were asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and in 6% on placebo (no Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients and 2% on placebo. One percent of XTANDI patients compared to 0.3% on placebo died from infections or sepsis. Falls or injuries related to falls occurred in 4.6% of XTANDI patients versus 1.3% on placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients and included non-pathologic fractures, joint injuries, and hematomas. Grade 1 or 2 hallucinations occurred in 1.6% of XTANDI patients and 0.3% on placebo, with the majority on opioid-containing medications at the time of the event.

Drug Interactions - Effect of Other Drugs on XTANDI: Administration of strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI. Co-administration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If co-administration of XTANDI cannot be avoided, reduce the dose of XTANDI. Co-administration of XTANDI with strong or moderate CYP3A4 and CYP2C8 inducers can alter the plasma exposure of XTANDI and should be avoided if possible.

Effect of XTANDI on Other Drugs - XTANDI is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4, CYP2C9 and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring. For Full Prescribing Information for XTANDI (enzalutamide) capsules, please visit www.XtandiHCP.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 being a global category leader in Oncology and Urology, 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.

About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs 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 the Astellas/Medivation Collaboration
In October 2009, Medivation and Astellas entered into a global agreement to jointly develop and commercialize enzalutamide. The companies are collaborating on a comprehensive development program that includes studies to develop enzalutamide across the full spectrum of advanced prostate cancer as well as advanced breast cancer. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.

Medivation Contact:
Mike Beyer
Sam Brown, Inc.(media for both companies)
(773) 463-4211

Astellas Contact:
Tyler Marciniak
Director, Communications and Advocacy
(847) 736-7145
Email Contact

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