Business Wire

Astellas Pharma Europe: Lancet Oncology Publishes Results from the Phase 2 TERRAIN Trial of Enzalutamide Compared to Bicalutamide in Metastatic Castration-Resistant Prostate Cancer


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:

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.



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.

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

Contact information

Astellas Corporate Communications
AJ Kenneally
+44 (0)7775 113515
Red Door Unlimited
Sarah Aldrige
+44 (0) 785 259 2971

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

FLIR Launches Thermal Traffic Sensor for Vehicle-to-Everything Communication20.3.2018 07:00Pressemelding

FLIR Systems, Inc. (NASDAQ: FLIR) today announced the launch of the FLIR ThermiCam™ V2X, a thermal traffic sensor for the emerging vehicle-to-everything (V2X) technology market. The FLIR V2X-enabled traffic sensor for urban traffic will allow vehicles and traffic infrastructure to communicate and share data in a system that aims to improve motorist, pedestrian, and bicyclist safety and efficiency. This press release features multimedia. View the full release here: FLIR ThermiCam V2X thermal traffic sensor designed for the emerging vehicle-to-everything (V2X) technology market will communicate with V2X-equipped vehicles. (Photo: Business Wire) V2X technology is an emerging crash avoidance system that relies on the communication of information between nearby vehicles and traffic infrastructure to warn drivers about potentially dangerous situations. In a V2X system, both the vehicles and infrastructure have communication units inst

Shopping on Instagram Goes Global with Shopify20.3.2018 06:00Pressemelding

Shopify Inc. (NYSE: SHOP) (TSX: SHOP), the leading multi-channel commerce platform, today announces its expanded integration with Instagram. The “shopping on Instagram” feature that allows businesses to tag products in Instagram posts is now enabled for merchants in eight additional markets: UK, Australia, Canada, Germany, France, Italy, Spain and Brazil. This strategic expansion unlocks potential for Shopify’s merchants to sell to Instagram users all over the world. Instagram, a fun, popular photo-sharing app for mobile devices, is a great venue for Shopify’s hundreds of thousands of merchants in categories such as fashion, jewelry, beauty, furniture and home decor to grow their customer base in a meaningful way. Riding on the successes from the earlier rollout for Shopify’s U.S. merchants, the expanded integration will allow shoppers all over the world to experience this unique commerce feature on Instagram. With the objective of helping our merchants reach more shoppers around the w

Oxford Nanopore Announces £100 Million ($140M) Fundraising from Global Investors20.3.2018 06:00Pressemelding

Oxford Nanopore Technologies Ltd, the company behind the only portable real-time DNA/RNA sequencer, MinION, has raised £100M ($140M) in new investment. Funds were raised from global investors including GIC (Singapore), China Construction Bank International (CCBI, China), Hostplus (Australia), and existing investors. This press release features multimedia. View the full release here: Oxford Nanopore’s novel DNA/RNA sequencing technology: the portable MinION is now being joined by other formats including high-throughput, on-demand PromethION and single-test Flongle (Graphic: Business Wire) The funds will be used to support the Company’s next phase of commercial expansion. This includes a new high-volume, high-tech manufacturing facility in Oxford to meet accelerating demand for Oxford Nanopore’s sequencing technology, and growth of the commercial team that already serves more than 70 countries. The funds raised will also support R

Milrem Robotics is Developing a Firefighting and Search and Rescue UGV20.3.2018 06:00Pressemelding

Known mostly for their smart warfare systems – Milrem Robotics – is entering the commercial market with its firefighting and search and rescue unmanned ground vehicle being developed together with rescue services. This press release features multimedia. View the full release here: Known mostly for their smart warfare systems - Milrem Robotics - is entering the commercial market with its firefighting and search and rescue unmanned ground vehicle being developed together with rescue services. (Photo: Business Wire) The UGV known as Multiscope Rescue can be equipped with firefighting equipment such as a water tank and a remotely controlled water cannon. It can reach areas that are unreachable by human personnel or too dangerous for firefighters to go into like tunnels or other structures that may collapse at any time. The search and rescue unit can also be equipped with thermal cameras and powerful lights to find missing people in

RagingWire Opens New VA3 Data Center and Ashburn Data Center Campus in the Heart of Famed "Data Center Alley"20.3.2018 02:09Pressemelding

RagingWire Data Centers, Inc., the premier data center provider in North America and its parent company NTT Communications (NTT Com), the information and communications technology (ICT) solutions and international communications business within the NTT Group (TOKYO: 9432), today announced the opening of its new Ashburn VA3 Data Center, a state-of-the-art facility with 245,000 square feet of space and 16 megawatts of critical power, located on RagingWire’s new Ashburn Data Center Campus. This press release features multimedia. View the full release here: RagingWire new Ashburn VA3 Data Center (Graphic: Business Wire) “With 16 megawatts available today at the new VA3 Data Center and massive scalability in our new Ashburn Data Center Campus, RagingWire has become the destination of choice for hyperscale, high-growth customers in the top data center market in the world,” said RagingWire President and CEO Doug Adams. “Plus our global

FAA Approves AerTrakTM to Comply with Automatic Dependent Surveillance-Broadcast (ADS-B) Operations Mandate19.3.2018 18:19Pressemelding

The Federal Aviation Administration (FAA) has issued a Supplemental Type Certificate (STC) for installation of AerSale®’s AerTrak™ system on Boeing 737 NG series aircraft (ST04009NY), to comply with the Automatic Dependent Surveillance-Broadcast (ADS-B) Operations rule, a critical part of the agency’s Next Generation Air Transportation System (NextGen). Beginning January 1, 2020, the FAA has mandated that aircraft operating in airspace defined by 14 CFR § 91.225 must be equipped with an ADS-B Out system that meets the minimum performance requirements of 14 CFR § 91.227. ADS-B provides enhanced navigational accuracy using precise tracking via global positioning satellite (GPS) signals. Reducing risk and improving safety, the technology increases navigational coverage, especially in remote areas beyond radar range. Additionally, ADS-B enables more direct flight plans, thereby saving time, costs, and reducing emissions. “AerTrak is a cost-effective ADS-B Out solution for operators of Boei