|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
It's time to face reality: "Americans are from Mars, Europeans are from Venus," and in today's increasingly connected world, understanding "inter-planetary" alignments and deviations is mission-critical for cloud. In her session at 15th Cloud Expo, Evelyn de Souza, Data Privacy and Compliance Strategy Leader at Cisco Systems, discussed cultural expectations of privacy based on new research across these elements
May. 26, 2015 06:00 AM EDT Reads: 3,398
In today's application economy, enterprise organizations realize that it's their applications that are the heart and soul of their business. If their application users have a bad experience, their revenue and reputation are at stake. In his session at 15th Cloud Expo, Anand Akela, Senior Director of Product Marketing for Application Performance Management at CA Technologies, discussed how a user-centric Application Performance Management solution can help inspire your users with every applicati...
May. 26, 2015 04:00 AM EDT Reads: 4,647
The consumption economy is here and so are cloud applications and solutions that offer more than subscription and flat fee models and at the same time are available on a pure consumption model, which not only reduces IT spend but also lowers infrastructure costs, and offers ease of use and availability. In their session at 15th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed this shifting dynamic with an ...
May. 26, 2015 02:00 AM EDT Reads: 3,133
As enterprises engage with Big Data technologies to develop applications needed to meet operational demands, new computation fabrics are continually being introduced. To leverage these new innovations, organizations are sacrificing market opportunities to gain expertise in learning new systems. In his session at Big Data Expo, Supreet Oberoi, Vice President of Field Engineering at Concurrent, Inc., discussed how to leverage existing infrastructure and investments and future-proof them against e...
May. 26, 2015 02:00 AM EDT Reads: 3,031
Due of the rise of Hadoop, many enterprises are now deploying their first small clusters of 10 to 20 servers. At this small scale, the complexity of operating the cluster looks and feels like general data center servers. It is not until the clusters scale, as they inevitably do, when the pain caused by the exponential complexity becomes apparent. We've seen this problem occur time and time again. In his session at Big Data Expo, Greg Bruno, Vice President of Engineering and co-founder of StackI...
May. 26, 2015 01:00 AM EDT Reads: 4,388
Once the decision has been made to move part or all of a workload to the cloud, a methodology for selecting that workload needs to be established. How do you move to the cloud? What does the discovery, assessment and planning look like? What workloads make sense? Which cloud model makes sense for each workload? What are the considerations for how to select the right cloud model? And how does that fit in with the overall IT transformation?
May. 26, 2015 12:00 AM EDT Reads: 4,189
The recent trends like cloud computing, social, mobile and Internet of Things are forcing enterprises to modernize in order to compete in the competitive globalized markets. However, enterprises are approaching newer technologies with a more silo-ed way, gaining only sub optimal benefits. The Modern Enterprise model is presented as a newer way to think of enterprise IT, which takes a more holistic approach to embracing modern technologies.
May. 25, 2015 11:00 PM EDT Reads: 5,921
For better or worse, DevOps has gone mainstream. All doubt was removed when IBM and HP threw up their respective DevOps microsites. Where are we on the hype cycle? It's hard to say for sure but there's a feeling we're heading for the "Peak of Inflated Expectations." What does this mean for the enterprise? Should they avoid DevOps? Definitely not. Should they be cautious though? Absolutely. The truth is that DevOps and the enterprise are at best strange bedfellows. The movement has its roots in t...
May. 25, 2015 10:00 PM EDT Reads: 6,212
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impac...
May. 25, 2015 09:00 PM EDT Reads: 4,756
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. 8th International Big Data Expo, co-located with 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. As advanced data storage, access and analytics technologies aimed at handling high-volume and/or fast moving data all move center stage, aided by the cloud computing bo...
May. 25, 2015 08:45 PM EDT Reads: 1,365
Every day we read jaw-dropping stats on the explosion of data. We allocate significant resources to harness and better understand it. We build businesses around it. But we’ve only just begun. For big payoffs in Big Data, CIOs are turning to cognitive computing. Cognitive computing’s ability to securely extract insights, understand natural language, and get smarter each time it’s used is the next, logical step for Big Data.
May. 25, 2015 08:00 PM EDT Reads: 1,871
There's no doubt that the Internet of Things is driving the next wave of innovation. Google has spent billions over the past few months vacuuming up companies that specialize in smart appliances and machine learning. Already, Philips light bulbs, Audi automobiles, and Samsung washers and dryers can communicate with and be controlled from mobile devices. To take advantage of the opportunities the Internet of Things brings to your business, you'll want to start preparing now.
May. 25, 2015 07:00 PM EDT Reads: 5,713
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
May. 25, 2015 07:00 PM EDT Reads: 1,522
Enterprises are fast realizing the importance of integrating SaaS/Cloud applications, API and on-premises data and processes, to unleash hidden value. This webinar explores how managers can use a Microservice-centric approach to aggressively tackle the unexpected new integration challenges posed by proliferation of cloud, mobile, social and big data projects. Industry analyst and SOA expert Jason Bloomberg will strip away the hype from microservices, and clearly identify their advantages and d...
May. 25, 2015 07:00 PM EDT Reads: 1,326
In a world of ever-accelerating business cycles and fast-changing client expectations, the cloud increasingly serves as a growth engine and a path to new business models. Dynamic clouds enable businesses to continuously reinvent themselves, adapting their business processes, their service and software delivery and their operations to achieve speed-to-market and quick response to customer feedback. As the cloud evolves, the industry has multiple competing cloud technologies, offering on-premises ...
May. 25, 2015 06:00 PM EDT Reads: 3,952