|By PR Newswire||
|February 3, 2014 04:11 AM EST||
HATFIELD, England, February 3, 2014 /PRNewswire/ --
Eisai announced today that the Phase III SELECT trial (Study 303) of lenvatinib, an investigational selective tyrosine kinase inhibitor (TKI) with a novel binding mode, met its primary endpoint. Compared to placebo, lenvatinib showed a highly statistically significant improvement in progression free survival (PFS) in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). The preliminary safety analyses showed that the five most common adverse reactions were hypertension, diarrhoea, decreased appetite, decreased weight and nausea.
The SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) study was a multicentre, randomised, double-blind, placebo-controlled Phase III study to compare the PFS of patients with RR-DTC and radiographic evidence of disease progression within the prior 12 months, treated with once-daily, oral lenvatinib (24mg) versus placebo. Secondary endpoints of the study included overall response rate (ORR), overall survival (OS) and safety. The study enrolled 392 patients in over 100 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group.
Based on these clinical results, Eisai will submit marketing authorisation applications for lenvatinib to health authorities in the U.S., Japan and Europe.
"These results show the potential role of the investigational drug lenvatinib in this rare, hard-to-treat cancer," said Kenichi Nomoto, PhD, President, Oncology Product Creation Unit, Eisai Product Creation Systems. "RR-DTC remains an unmet need with a limited number of treatment options."
Thyroid cancer is the most common endocrine malignancy and global figures show that its incidence has increased significantly over the last 50 years. In Europe alone, almost 63,000 cases of thyroid cancer were diagnosed in 2012. Differentiated thyroid cancer accounts for approximately 90% of all thyroid cancers. For the majority of patients prognosis is good with a survival rate of 85% at ten years. For those patients whose cancer is refractory to radioiodine treatment, prognosis is poor with a ten-year survival rate of 15%.
Lenvatinib, discovered and developed by Eisai, was granted orphan drug designation (ODD) for the treatment of follicular and papillary thyroid cancer by the European Commission in April 2013. This followed ODD in the U.S. for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer and Japan (thyroid cancer).
Eisai has also initiated a global Phase III trial of lenvatinib in hepatocellular carcinoma (HCC) and is conducting Phase II studies of lenvatinib in several other tumour types. Eisai is committed to understanding the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer, including patients with RR-DTC, and their families.
The development of lenvatinib underscores Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of oncology and addressing the unmet medical needs of patients and their families.
Notes to Editors
Lenvatinib is an orally active, selective inhibitor of receptor tyrosine kinases (RTKs), including KDR (VEGFR-2), Flt-1 (VEGFR-1), FGFR1, PDGFR-β and c-kit involved in angiogenesis and tumour proliferation., It is currently under investigation as a treatment for thyroid, hepatocellular, endometrial and other solid tumour types. Eisai has initiated a global Phase III trial with lenvatinib in hepatocellular carcinoma (HCC) and is conducting Phase II studies of lenvatinib in several other tumour types.
About Thyroid Cancer
Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea. It is more common in women than in men and most are in their 40s or 50s at time of diagnosis.
The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 90% of all cases. The remaining cases are classified as either medullary (5-7% of cases) or anaplastic (1-2% of cases).While most DTC patients are curable with surgery and radioactive iodine treatment, the prognosis for those patients who do respond is poor.  There are limited treatment options for this difficult-to-treat, life-threatening and treatment-refractory form of thyroid cancer.
Eisai in Oncology
Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.
Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and we define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).
Eisai concentrates its R&D activities in three key areas:
- Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc.
- Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss
- Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease
With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Luxembourg, Russia and the Middle East.
For further information please visit our web site http://www.eisai.co.uk
About the SFJ Pharmaceuticals Group
The SFJ Pharmaceuticals Group, which includes SFJ Pharma Ltd., is a Global Drug Development Company, which provides a unique co-development partnering model for some of the world's top Pharmaceutical and Biotechnology companies. SFJ uses its financial strength and core team of pharmaceutical development experts to provide highly customised partnering models in which SFJ provides the funding and clinical development supervision, necessary to obtain regulatory approval for some of the most promising drug development programmes of Pharmaceutical and Biotechnology companies.
1. Data on file, Eisai.Co.Ltd
2. Brito J et al. Thyroid cancer: zealous imaging has increased detection and treatment of low risk tumours. BMJ 2013; 347
3. Thyroid Cancer. International Agency for Research on Cancer. http://eco.iarc.fr/eucan/Cancer.aspx?Cancer=35 (last accessed: October 2013)
4. Deshpande H, et al. Axitinib: The evidence of its potential in the treatment of advanced thyroid cancer. Core Evidence 2009; 4: 43-48
5. Gild M et al. Multikinase inhibitors: a new option for the treatment of thyroid cancer. Nature Reviews Endocrinology. 2011; 7: 617-624
6. Matsui J, Funahashi Y, Uenaka T et al. Multi-kinase inhibitor E7080 suppresses lymph node and lung metastases of human mammary breast tumour MDA-MB-231 via inhibition of vascular endothelial growth factor-receptor (VEGF-R) 2 and VEGF-R3 kinase. Clin Cancer Res 2008; 14: 5459-65
7. Matsui J, Yamamoto Y, Funahashi Y, et al. E7080, a novel inhibitor that targets multiple kinases, has potent anti-tumour activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer 2008; 122: 664-71
8. National Cancer Institute at the National Institute of Health http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/A... [http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/AllPages ] (last accessed: January 2014)
9. Cooper DS et al. Thyroid. 2009;19(11):1167-1214
10. Thyroid Cancer Basics. 2011. http://www.thyca.org
11. Bible K, Suman V, Molina J et al. Efficacy of pazopanib in progressive, radioiodine-refractory metastatic differentiated thyroid cancers: results of a phase 2 consortium study. Lancet Oncology 2010; 11(10): 962-972
Job code: lenvatinib-UK0019 Date of preparation: February 2014
Enterprise IT has been in the era of Hybrid Cloud for some time now. But it seems most conversations about Hybrid are focused on integrating AWS, Microsoft Azure, or Google ECM into existing on-premises systems. Where is all the Private Cloud? What do technology providers need to do to make their offerings more compelling? How should enterprise IT executives and buyers define their focus, needs, and roadmap, and communicate that clearly to the providers?
Dec. 10, 2016 06:00 AM EST Reads: 693
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 10, 2016 04:45 AM EST Reads: 1,092
"We are a leader in the market space called network visibility solutions - it enables monitoring tools and Big Data analysis to access the data and be able to see the performance," explained Shay Morag, VP of Sales and Marketing at Niagara Networks, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 10, 2016 04:30 AM EST Reads: 531
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
Dec. 10, 2016 04:15 AM EST Reads: 1,387
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...
Dec. 10, 2016 04:15 AM EST Reads: 555
Organizations planning enterprise data center consolidation and modernization projects are faced with a challenging, costly reality. Requirements to deploy modern, cloud-native applications simultaneously with traditional client/server applications are almost impossible to achieve with hardware-centric enterprise infrastructure. Compute and network infrastructure are fast moving down a software-defined path, but storage has been a laggard. Until now.
Dec. 10, 2016 04:00 AM EST Reads: 5,522
We're entering the post-smartphone era, where wearable gadgets from watches and fitness bands to glasses and health aids will power the next technological revolution. With mass adoption of wearable devices comes a new data ecosystem that must be protected. Wearables open new pathways that facilitate the tracking, sharing and storing of consumers’ personal health, location and daily activity data. Consumers have some idea of the data these devices capture, but most don’t realize how revealing and...
Dec. 10, 2016 04:00 AM EST Reads: 5,316
IoT solutions exploit operational data generated by Internet-connected smart “things” for the purpose of gaining operational insight and producing “better outcomes” (for example, create new business models, eliminate unscheduled maintenance, etc.). The explosive proliferation of IoT solutions will result in an exponential growth in the volume of IoT data, precipitating significant Information Governance issues: who owns the IoT data, what are the rights/duties of IoT solutions adopters towards t...
Dec. 10, 2016 03:15 AM EST Reads: 490
Get deep visibility into the performance of your databases and expert advice for performance optimization and tuning. You can't get application performance without database performance. Give everyone on the team a comprehensive view of how every aspect of the system affects performance across SQL database operations, host server and OS, virtualization resources and storage I/O. Quickly find bottlenecks and troubleshoot complex problems.
Dec. 10, 2016 02:45 AM EST Reads: 2,270
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Dec. 10, 2016 02:15 AM EST Reads: 795
Between 2005 and 2020, data volumes will grow by a factor of 300 – enough data to stack CDs from the earth to the moon 162 times. This has come to be known as the ‘big data’ phenomenon. Unfortunately, traditional approaches to handling, storing and analyzing data aren’t adequate at this scale: they’re too costly, slow and physically cumbersome to keep up. Fortunately, in response a new breed of technology has emerged that is cheaper, faster and more scalable. Yet, in meeting these new needs they...
Dec. 10, 2016 02:00 AM EST Reads: 1,995
Complete Internet of Things (IoT) embedded device security is not just about the device but involves the entire product’s identity, data and control integrity, and services traversing the cloud. A device can no longer be looked at as an island; it is a part of a system. In fact, given the cross-domain interactions enabled by IoT it could be a part of many systems. Also, depending on where the device is deployed, for example, in the office building versus a factory floor or oil field, security ha...
Dec. 10, 2016 02:00 AM EST Reads: 627
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
Dec. 10, 2016 01:30 AM EST Reads: 4,001
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for s...
Dec. 10, 2016 01:30 AM EST Reads: 793
"We are the public cloud providers. We are currently providing 50% of the resources they need for doing e-commerce business in China and we are hosting about 60% of mobile gaming in China," explained Yi Zheng, CPO and VP of Engineering at CDS Global Cloud, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 10, 2016 01:15 AM EST Reads: 1,225