|By PR Newswire||
|January 17, 2014 05:40 PM EST||
MELBOURNE, Australia, Jan. 17, 2014 /PRNewswire/ --
- Study shows ABRAXANE plus gemcitabine combination therapy further extends overall survival benefit
- First Phase III trial in metastatic pancreatic cancer to report three year survival rates
- New standard of care for patients with metastatic pancreatic cancer
A leading breast cancer drug, ABRAXANE® (nanoparticle albumin-bound paclitaxel), has been shown to extend overall survival (OS) for patients with metastatic pancreatic cancer when used in combination with current standard of care, gemcitabine, with some patients surviving longer than three years.
The updated OS data from the pivotal Phase III Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT)[1-2] of ABRAXANE in combination with gemcitabine, was presented at the recent American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Conference in San Francisco by Australian Oncologist, Professor David Goldstein.
Professor Goldstein, who is based at the Prince of Wales Hospital in New South Wales, said that the data was "extremely encouraging" and paved the way for ABRAXANE to be used as a first-line therapy in the treatment of pancreatic cancer.
"Importantly, this large multinational trial in metastatic pancreatic cancer has demonstrated important three year survival rates, with 4% of patients in the ABRAXANE plus gemcitabine arm alive after three years, compared to none in the gemcitabine alone arm, and a near 30% improvement in survival outcomes," he said.
"This cancer is the fourth most common cancer in Australia for both men and women and typically patients diagnosed with metastatic pancreatic cancer have a median life expectancy of approximately three to six months. These patients have very limited treatment options as there have been no new medications approved for metastatic pancreatic cancer in nearly seven years.
Data from this important study shows that ABRAXANE when used in conjunction with standard of care gemcitabine can substantially improve OS, with predictable and manageable side effects."
The MPACT study was conducted at a number of sites internationally, including 20 sites in Australia, and involved 861 patients, of which 120 were Australian.
The median survival benefit in the updated analysis was extended in the ABRAXANE + gemcitabine arm with a 2.1 month OS improvement compared to gemcitabine alone (OS; median 8.7 months vs 6.6 months; HR=0.72; p<0.0001). This compares favourably with the 1.8 months improvement previously reported in the New England Journal of Medicine (OS; median 8.5 months vs 6.7 months; HR=0.72; p<0.00001).
The Chief Executive Officer of Australian biopharmaceutical company, Specialised Therapeutics Australia (STA), Mr Carlo Montagner, said ABRAXANE is currently approved in the United States and Europe as a first-line therapy in combination with gemcitabine for patients with metastatic pancreatic cancer.
He said a submission to the Therapeutic Goods Administration (TGA) for the regulatory approval of ABRAXANE (in combination with gemcitabine) for first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the pancreas was made in 2013. An application for a Pharmaceutical Benefits Scheme (PBS) listing for this indication has also been submitted with the Pharmaceutical Benefits Advisory Committee (PBAC) and will be reviewed at the March 2014 meeting.
Mr Montagner commented, "We are extremely pleased with these results presented at the ASCO GI conference and look forward to a TGA approval for ABRAXANE and a subsequent PBS listing for Australian patients with this difficult to treat cancer."
ABRAXANE is currently TGA approved for the treatment of metastatic breast cancer and first-line Non Small Cell Lung Cancer (NSCLC).
About the MPACT Study
The MPACT study was a Celgene-sponsored, open-label, randomised, international study of 861 patients with metastatic pancreatic cancer. Patients were randomised to receive either ABRAXANE plus gemcitabine (125 mg/m2 followed by 1000 mg/m2 gemcitabine for 3 weeks followed by a week of rest) or gemcitabine alone (1000 mg/m2 administered weekly for 7 weeks followed by a week of rest followed by cycles of weekly administration for 3 weeks followed by one week of rest).
The primary endpoint for the study was overall survival. Secondary endpoints were progression-free survival and overall response rate determined by independent radiological review. Other endpoints included progression-free survival and overall response rate determined by investigator, and the safety and tolerability of this combination in this patient population.
About Advanced Pancreatic Cancer
Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. Across all patients with pancreatic cancer, relative 5-year survival is approximately 5% and is less than 2% for those with advanced disease. There are two main types of pancreatic cancer - adenocarcinomas, which account for approximately 90% of all pancreatic cancer, and neuroendocrine tumours. Pancreatic cancer is relatively uncommon with new cases accounting for only 2.1% of all newly diagnosed cancers. However, pancreatic cancer is the fourth most common cause of cancer death for men and women in Australia, and the ninth most commonly diagnosed cancer in Australia.
ABRAXANE is a solvent-free, nanoparticle chemotherapy treatment option approved for the treatment of metastatic breast cancer and NSCLC.
ABRAXANE is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. ABRAXANE, in combination with carboplatin, is indicated for the first-line treatment of NSCLC in patients who are not candidates for potentially curative surgery and/or radiation.
In Australia, ABRAXANE is currently listed on the PBS for the treatment of metastatic breast cancer and HER2 positive breast cancer in combination with trastuzumab. ABRAXANE is not listed on the PBS for the indication of NSCLC.
ABRAXANE is approved for metastatic breast cancer in over 40 countries including the U.S., Canada, European Union, Japan and China, and more than 180,000 cancer patients have received ABRAXANE therapy in the past five years.
ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: metastatic melanoma, adjuvant pancreatic cancer, bladder cancer, ovarian cancer, and expanded applications for breast cancer.
Developed using the proprietary nab(TM) technology platform, ABRAXANE is a nanoparticle protein-bound chemotherapy agent. ABRAXANE combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminates the need for solvents in the administration process. Nanoparticle technology allows ABRAXANE to deliver a 49% higher dose compared to regular solvent-based paclitaxel without compromising safety and tolerability[4-5].
Contraindications and Side Effects:
Like all medications, ABRAXANE may cause side effects.
ABRAXANE should not be used in patients who have baseline neutrophil counts of <1.5 x 109 /L.
Patients who have exhibited hypersensitivity reactions to ABRAXANE or human albumin should not be treated with ABRAXANE.
ABRAXANE is contraindicated during pregnancy and lactation.
Most common side effects (≥1/10) caused by ABRAXANE include; neutropenia, anaemia, leucopenia, thrombocytopenia, lymphophenia, anorexia, peripheral neuropathy, hypoaesthesia, paraethesia, nausea, diarrhoea, vomiting, constipation, stomatitis, alopecia, rash, arthralgia, myalgia, fatigue, asthenia, pyrexia. This is not a full list of all the side effects.
Before prescribing or for further information regarding ABRAXANE and potential side effects, physicians should review the ABRAXANE Product Information at www.specialisedtherapeutics.com.au
Patients should consult their oncologist or the ABRAXANE Consumer Medicine Information available at www.specialisedtherapeutics.com.au
ABRAXANE® is a registered trademark of Celgene Corporation.
ABRAXANE® is under license from Celgene Corporation and distributed by STA in Australia and New Zealand.
About Specialised Therapeutics Australia Pty Ltd
Specialised Therapeutics Australia Pty Ltd (STA) is a biopharmaceutical company dedicated to working with leading pharmaceutical companies worldwide to provide acute care therapies for high unmet medical needs to people living in Australia and New Zealand. The STA therapeutic portfolio and pipeline at present encompasses oncology and infectious diseases. STA also has interests in the therapeutic areas of respiratory, dermatology, endocrinology and central nervous system (CNS). Additional information can be found at www.specialisedtherapeutics.com.au.
- Goldstein D et al. Oral Abstract # 178. Updated survival from a randomized phase III trial (MPACT) of nab-Paclitaxel plus gemcitabine versus gemcitabine alone for patients (pts) with metastatic adenocarcinoma of the pancreas. ASCO GI 2014.
- Von Hoff DD et al. Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine. N Engl J Med 2013; 369(18):1691-703.
- Cancer in Australia. An Overview 2012. Australian Institute of Health and Welfare (AIHW)
- ABRAXANE Product Information
- Gradishar WJ et al. J Clinical Oncology 2005; 23:7794-7803
+61 419 149 525
SOURCE Specialised Therapeutics Australia Pty Ltd
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
Mar. 25, 2017 03:15 PM EDT Reads: 6,388
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
Mar. 25, 2017 03:00 PM EDT Reads: 2,678
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
Mar. 25, 2017 01:45 PM EDT Reads: 3,236
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Mar. 25, 2017 01:30 PM EDT Reads: 1,621
The taxi industry never saw Uber coming. Startups are a threat to incumbents like never before, and a major enabler for startups is that they are instantly “cloud ready.” If innovation moves at the pace of IT, then your company is in trouble. Why? Because your data center will not keep up with frenetic pace AWS, Microsoft and Google are rolling out new capabilities In his session at 20th Cloud Expo, Don Browning, VP of Cloud Architecture at Turner, will posit that disruption is inevitable for c...
Mar. 25, 2017 01:15 PM EDT Reads: 1,994
SYS-CON Events announced today that Cloudistics, an on-premises cloud computing company, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloudistics delivers a complete public cloud experience with composable on-premises infrastructures to medium and large enterprises. Its software-defined technology natively converges network, storage, compute, virtualization, and management into a ...
Mar. 25, 2017 12:45 PM EDT Reads: 1,823
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
Mar. 25, 2017 12:45 PM EDT Reads: 3,440
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Mar. 25, 2017 12:45 PM EDT Reads: 1,610
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
Mar. 25, 2017 12:30 PM EDT Reads: 5,022
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
Mar. 25, 2017 12:30 PM EDT Reads: 1,119
What if you could build a web application that could support true web-scale traffic without having to ever provision or manage a single server? Sounds magical, and it is! In his session at 20th Cloud Expo, Chris Munns, Senior Developer Advocate for Serverless Applications at Amazon Web Services, will show how to build a serverless website that scales automatically using services like AWS Lambda, Amazon API Gateway, and Amazon S3. We will review several frameworks that can help you build serverle...
Mar. 25, 2017 12:30 PM EDT Reads: 1,741
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 20th Cloud Expo, which will take place on June 6-8, 2017 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 add...
Mar. 25, 2017 12:00 PM EDT Reads: 863
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Mar. 25, 2017 11:15 AM EDT Reads: 1,483
Interoute has announced the integration of its Global Cloud Infrastructure platform with Rancher Labs’ container management platform, Rancher. This approach enables enterprises to accelerate their digital transformation and infrastructure investments. Matthew Finnie, Interoute CTO commented “Enterprises developing and building apps in the cloud and those on a path to Digital Transformation need Digital ICT Infrastructure that allows them to build, test and deploy faster than ever before. The int...
Mar. 25, 2017 11:15 AM EDT Reads: 765
SYS-CON Events announced today that CrowdReviews.com has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. CrowdReviews.com is a transparent online platform for determining which products and services are the best based on the opinion of the crowd. The crowd consists of Internet users that have experienced products and services first-hand and have an interest in letting other potential buyers...
Mar. 25, 2017 11:00 AM EDT Reads: 3,501