|By PR Newswire||
|February 27, 2014 08:15 AM EST||
WOODCLIFF LAKE, N.J., Feb. 27, 2014 /PRNewswire/ -- Eisai Inc. today announced the start of a large, randomized Phase 3 trial to compare the efficacy, safety and tolerability of eribulin mesylate to standard weekly paclitaxel as a first- or second- line treatment for HER2-negative locally recurrent or metastatic breast cancer (MBC). Recruitment is currently active for this multicenter study, conducted in partnership with the Academic and Community Cancer Research United (ACCRU) group, and aims to enroll approximately 910 patients across the U.S. The primary endpoint is overall survival.
This research study involves an investigational use of eribulin mesylate. The efficacy and safety of eribulin mesylate in first- and second-line MBC have not been established and this release is not intended to convey conclusions of efficacy and safety.
"As a human healthcare company, Eisai is committed to further exploring new treatments for metastatic breast cancer patients," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai.
About The Study
This study is for HER2-negative breast cancer patients who have received no more than one prior chemotherapy regimen once their breast cancer has spread. Eligible patients will be randomly selected with equal allocation (1:1) to receive treatment for their cancer with either eribulin mesylate or standard weekly paclitaxel, within strata defined by prior adjuvant taxanes, hormone receptor status (ER/PgR), and line of therapy.
The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival and objective tumor response rate. Safety and tolerability of the treatment groups will also be continuously monitored.
To learn more about this clinical trial, please visit www.clinicaltrials.gov/show/NCT02037529.
About Metastatic Breast Cancer
Metastatic breast cancer (MBC) is the form of the disease that refers to the most advanced stage, in which cancer cells break away from the tumor in the breast, spread to other parts of the body and continue growing. In 2013, an estimated 234,580 women will be diagnosed with breast cancer in the U.S. Approximately 30 percent of patients having an initial diagnosis of early-stage breast cancer will go on to develop recurrent, advanced or MBC.
About Eribulin Mesylate Injection
Eribulin mesylate injection (available as Halaven®) is currently indicated for patients with breast cancer who have received at least two other types of medicines for their breast cancer once it has spread. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer. Eribulin is a non-taxane, microtubule dynamics inhibitor that is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai.
Important Safety Information
- Decreased White Blood Cells (Neutropenia)
- Doctors should do blood tests to monitor patients' blood cells before they receive each dose of HALAVEN, and should monitor them more often if they develop lower white blood cells.
- If patients develop severe neutropenia lasting longer than 7 days or neutropenia with a fever, their next dose of HALAVEN should be delayed and reduced. Severe neutropenia occurred in 57% of patients who received HALAVEN and lasted more than 1 week in 12% of patients.
- Neutropenia with a fever occurred in 5% of patients; 2 patients died from complications of neutropenia with a fever.
- Neutropenia with a fever can result in serious infections that could lead to hospitalization or death. Patients should call their healthcare providers immediately if they have any of the following symptoms; fever (temperature above 100.5 ۫ F), chills, coughing, burning or pain when they urinate.
- Nerve Disorders (Peripheral Neuropathy)
- HALAVEN can cause numbness, tingling, or burning in a patient's hands and feet (peripheral neuropathy). Patients should be monitored closely for signs of neuropathy. If they develop severe neuropathy, treatment with HALAVEN should be delayed until the neuropathy improves and the next dose of HALAVEN should be reduced.
- Severe peripheral neuropathy occurred in 8% of patients who received HALAVEN. Neuropathy lasting more than one year occurred in 5% of patients. 22% of patients developed a new or worsening neuropathy that had not recovered after an average of 269 days.
- Peripheral neuropathy was the most common side effect that caused patients to stop receiving HALAVEN.
- Pregnancy and Nursing
- HALAVEN may harm a patient's unborn baby. Patients must avoid becoming pregnant while they are receiving HALAVEN. They should tell their healthcare providers right away if they become pregnant or think they are pregnant while they are receiving HALAVEN.
- Patients and their healthcare providers should decide if they will receive HALAVEN or breastfeed. They should not do both.
- Heartbeat Changes
- HALAVEN can cause changes in a patient's heartbeat (called QTc prolongation). This can cause irregular heartbeats that may lead to death.
- Healthcare providers will decide if patients need heart monitoring (electrocardiogram or ECG), or blood tests during their treatment with HALAVEN to watch for this problem.
- Liver and Kidney Problems
- In patients with mild or moderate liver problems, and/or moderate kidney problems, a lower starting dose of HALAVEN is recommended.
- Most Common Side Effects
- The most common side effects reported in >25% of patients receiving HALAVEN were low white blood cells (82%), low red blood cells (58%), weakness/tiredness (54%), hair loss (45%), numbness, tingling or burning in your hands and feet (35%), nausea (35%), and constipation (25%).
- The most common serious side effects reported in patients receiving HALAVEN were neutropenia with or without a fever (4% and 2%, respectively).
Please see the HALAVEN full prescribing information.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
The Academic and Community Cancer Research United (ACCRU) is a clinical research group whose operations are based at the Mayo Clinic Cancer Center in Rochester, Minn. ACCRU includes a network of more than 65 academic and community-based cancer treatment clinics and hospitals in the United States and Canada. ACCRU, formerly Mayo Clinic Cancer Research Consortium (MCCRC), was established in 2004 to conduct clinical trials to improve cancer care.
HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
SOURCE Eisai Inc.
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Aug. 2, 2015 05:45 PM EDT Reads: 498
Chuck Piluso presented a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. Prior to Secure Infrastructure and Services, Mr. Piluso founded North American Telecommunication Corporation, a facilities-based Competitive Local Exchange Carrier licensed by the Public Service Commission in 10 states, serving as the company's chairman and president from 1997 to 2000. Between 1990 and 1997, Mr. Piluso served as chairman & founder of International Te...
Aug. 2, 2015 04:00 PM EDT Reads: 409
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
Aug. 2, 2015 03:00 PM EDT Reads: 532
Container technology is sending shock waves through the world of cloud computing. Heralded as the 'next big thing,' containers provide software owners a consistent way to package their software and dependencies while infrastructure operators benefit from a standard way to deploy and run them. Containers present new challenges for tracking usage due to their dynamic nature. They can also be deployed to bare metal, virtual machines and various cloud platforms. How do software owners track the usag...
Aug. 2, 2015 02:00 PM EDT Reads: 231
SYS-CON Events announced today that MobiDev, a software development company, will exhibit at the 17th International Cloud Expo®, which will take place November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software development company with representative offices in Atlanta (US), Sheffield (UK) and Würzburg (Germany); and development centers in Ukraine. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobi...
Aug. 2, 2015 12:00 PM EDT Reads: 337
With SaaS use rampant across organizations, how can IT departments track company data and maintain security? More and more departments are commissioning their own solutions and bypassing IT. A cloud environment is amorphous and powerful, allowing you to set up solutions for all of your user needs: document sharing and collaboration, mobile access, e-mail, even industry-specific applications. In his session at 16th Cloud Expo, Shawn Mills, President and a founder of Green House Data, discussed h...
Aug. 2, 2015 11:45 AM EDT Reads: 476
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducte...
Aug. 2, 2015 11:15 AM EDT Reads: 347
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. In his session at 15th Cloud Expo, Michael Meiner, an Engineering Director at Oracle, Corporation, analyzed a range of cloud offerings (IaaS, PaaS, SaaS) and discussed the benefits/challenges of migrating to each offe...
Aug. 2, 2015 11:00 AM EDT Reads: 165
One of the hottest areas in cloud right now is DRaaS and related offerings. In his session at 16th Cloud Expo, Dale Levesque, Disaster Recovery Product Manager with Windstream's Cloud and Data Center Marketing team, will discuss the benefits of the cloud model, which far outweigh the traditional approach, and how enterprises need to ensure that their needs are properly being met.
Aug. 2, 2015 09:00 AM EDT Reads: 1,697
In their session at 17th Cloud Expo, Hal Schwartz, CEO of Secure Infrastructure & Services (SIAS), and Chuck Paolillo, CTO of Secure Infrastructure & Services (SIAS), provide a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. In his role as CEO of Secure Infrastructure & Services (SIAS), Hal Schwartz provides leadership and direction for the company.
Aug. 2, 2015 08:15 AM EDT Reads: 176
In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.
Aug. 2, 2015 07:00 AM EDT Reads: 179
"We've just seen a huge influx of new partners coming into our ecosystem, and partners building unique offerings on top of our API set," explained Seth Bostock, Chief Executive Officer at IndependenceIT, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Aug. 1, 2015 09:00 PM EDT Reads: 671
Mobile, social, Big Data, and cloud have fundamentally changed the way we live. “Anytime, anywhere” access to data and information is no longer a luxury; it’s a requirement, in both our personal and professional lives. For IT organizations, this means pressure has never been greater to deliver meaningful services to the business and customers.
Aug. 1, 2015 11:15 AM EDT Reads: 195
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
Aug. 1, 2015 10:00 AM EDT Reads: 333
Puppet Labs has announced the next major update to its flagship product: Puppet Enterprise 2015.2. This release includes new features providing DevOps teams with clarity, simplicity and additional management capabilities, including an all-new user interface, an interactive graph for visualizing infrastructure code, a new unified agent and broader infrastructure support.
Aug. 1, 2015 09:45 AM EDT Reads: 202