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Patients Receiving 125mg/m2 ABRAXANE in Combination with Gemcitabine Demonstrated:
* Median Survival of 12.2 Months
* 50 Percent Response Rate
* 68 Percent Disease Control
* Decrease in CA19-9 Tumor Biomarker Levels in 100 Percent of Patients Treated
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced updated overall survival findings from a phase I/II study of nab®-paclitaxel (ABRAXANE® for Injectable Suspension) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) given in combination with gemcitabine, demonstrated increased survival of the first-line treatment of patients with advanced pancreatic cancer. In 44 patients treated at the recommended dose of 125 mg/m2 nab-paclitaxel plus gemcitabine (1000 mg/m2), the median overall survival (OS) time was 12.2 months, a doubling of survival compared to historical control of gemcitabine administered alone.i This combination of nab-paclitaxel and gemcitabine also resulted in a confirmed overall response rate in 50 percent of patients treated, and a disease control rate (CR, PR and stable disease for 16 weeks or longer according to RECIST criteria) of 68 percent. In the overall study (n=67), three patients achieved a complete response. These findings were discussed during a keynote address by Daniel Von Hoff, M.D., "Epithelium and Stroma: Double Trouble," during the "Progress in Pancreatic Cancer" session on April 18 at the 101st Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington, D.C.
"The results of this study demonstrate that the combination of nab-paclitaxel and gemcitabine at the recommended dose of 125 mg/m2 nab-paclitaxel has substantial antitumor activity. One hundred percent of the patients in the 125 mg/m2 nab-paclitaxel arm (n=44) tested for the serum carbohydrate antigen CA 19-9 demonstrated a greater than 20 percent decrease in levels of the tumor marker, a degree of decrease which has been shown to be correlated with improved overall survival.i,ii,iii" said Daniel Von Hoff, M.D., F.A.C.P., Physician-in-Chief, Senior Investigator, Translational Genomics Research Institute (TGen); Clinical Professor of Medicine, University of Arizona; and Chief Scientific Officer, Scottsdale Healthcare and U.S. Oncology Research.
The biomarker CA19-9 is a tumour-associated antigen that has been shown to be a highly specific and sensitive for pancreatic cancer; approximately three-quarters of all pancreatic cancer patients have elevated baseline serum CA19-9 level at baseline.iv Of the 54 patients in the trial interrogated for CA 19-9, 69 percent had a greater than 70 percent decrease in levels of the biomarker, which correlated to a median overall survival of 15.6 months in this subset.
"The mechanism of transport of ABRAXANE is believed to exploit the albumin-binding protein receptor Gp-60 in the blood vessel wall, opening a portal to the tumor micro-environment through the Gp-60/Caveolin-1 transcytosis pathway. By creating this highway from the blood to the tumor microenvironment, the potential thus exists to deliver a high concentration of paclitaxel as well as other cytotoxic agents given in combination with nab-paclitaxel to this site, thereby achieving stromal collapse and high intra-tumoral drug concentration. This portal to the microenvironment may create a new paradigm for the treatment of solid tumors by potentially establishing a capability for enhanced delivery of cytotoxics when given in combination with nab-paclitaxel," said Patrick Soon-Shiong, M.D., Executive Chairman and founder of Abraxis BioScience.
The updated survival data follow interim data from the Phase I/II pancreatic clinical trial presented at the 45th Annual Meeting of the American Society of Clinical Oncology. The combination of nab-paclitaxel (125mg/m2) and gemcitabine (1000 mg/m2) is now the treatment arm of a randomized Phase 3 clinical trial that is currently enrolling patients.
Pancreatic cancer is particularly difficult to treat because many patients are diagnosed after their disease has progressed. This year, more than 42,000 people are expected to be diagnosed with pancreatic cancer in the United States and more than 35,000 people will die from the disease.v Recent research indicates that an exceptionally dense stroma around pancreatic tumors contributes to treatment difficulty, and that delivery systems that can break through this surrounding mass may deliver more drug to the cells and improve outcome.vi
ABRAXANE is currently approved for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE has also been granted orphan drug designation by the Food and Drug Administration for the treatment of pancreatic cancer as well as stage IIB-IV melanoma.
About the Study
In this open-label Phase I/II study, 67 patients with advanced pancreatic cancer were treated. Patients were 18 years of age and older with histologically confirmed metastatic adenocarcinoma of the pancreas and had no islet cell neoplasms, locally invasive disease, or prior chemotherapy for metastatic disease. In the Phase I dose escalation portion of the study, nab-paclitaxel (100, 125, or 150 mg/m2) in combination with gemcitabine (1,000 mg/m2) was administered weekly for three weeks (on days one, eight and 15) with one week of rest. The primary safety endpoint for this study was the identification of the maximum tolerated dose and dose-limiting toxicity of the nab-paclitaxel and gemcitabine combinations studied, while the secondary safety endpoint was the incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs). Efficacy endpoints included evaluations of confirmed response rates (complete or partial responses by RECIST criteria), stable disease for 16 weeks or longer, disease progression (PD), progression-free survival (PFS) and overall survival (OS).
Investigator-assessed responses (61 evaluable patients) were determined via CT scans using RECIST criteria. An additional independent radiological review was conducted on PET scans (45 evaluable patients) using EORTC criteria as well as CT scans using RECIST criteria. All reported data resulted from the Phase I/II study and have not been reviewed by the Food and Drug Administration.
The ABRAXANE 125 mg/m2 plus gemcitabine 1,000 mg/m2 arm was identified as the maximum tolerated dose. In this treatment arm, the most common grade 3 and 4 adverse event that occurred in more than 20 percent of patients was neutropenia; grade 3 events occurred in 13 patients (30 percent) and grade 4 events occurred in 19 patients (44 percent). Grade 3 sensory neuropathy and fatigue and grade 3 and 4 thrombocytopenia were also observed. One combination-associated death due to sepsis occurred in a patient receiving ABRAXANE 150 mg/m2.
i A.H. Ko, J. Hwang, A.P. Venook, J.L. Abbruzzese, E.K. Bergsland and M.A. Tempero. Serum CA19-9 response as a surrogate for clinical outcome in patients receiving fixed-dose rate gemcitabine for advanced pancreatic cancer. British Journal of Cancer. July 5, 2005, Volume 93, 195 - 199.
ii A.H. Ko, E. Dito, B. Schillinger, A.P. Venook, E.K. Bergsland and M.A. Tempero. Phase II Study of Fixed Dose Rate Gemcitabine With Cisplatin for Metastatic Adenocarcinoma of the Pancreas. Journal of Clinical Oncology. January 20, 2006, Volume 24, Issue 3, 379-385.
iii N.R. Maisey, A.R. Norman, A. Hill, A. Massey, J. Oates and D. Cunningham. CA19-9 as a prognostic factor in inoperable pancreatic cancer: the implication for clinical trials. British Journal of Cancer. September 20, 2005, Volume 93, 740 - 743.
iv C.Yeo, M. Tempero, and R. Abrams R. Pancreas cancer: clinical management. In Gastrointestinal Oncology: Principles and Practices. J. Tepper (ed), 2002. Philadelphia: Lippincott Williams and Wilkins
v American Cancer Society. Cancer Facts & Figures 2009. Atlanta: American Cancer Society; 2009. Available at www.cancer.org/docroot/STT/STT_0.asp.
vi K. Garber. Stromal Depletion Goes on Trial in Pancreatic Cancer. Journal of the National Cancer Institute. April 7, 2010, Volume 102, Issue 7, 448-450.
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the clinical development plan, and the timing and scope of clinical studies and trials, for ABRAXANE and the global commercialization of ABRAXANE. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the fact that results from pre-clinical studies may not be predictive of results to be obtained in other pre-clinical studies or future clinical trials; delays in commencement and completion of clinical studies or trials, including slower than anticipated patient enrollment and adverse events occurring during the clinical trials; decisions by regulatory authorities regarding whether and when to approve ABRAXANE or product candidates for various indications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of ABRAXANE and other products and product candidates; unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE or product candidates; the need for additional data or clinical studies for ABRAXANE or product candidates; regulatory developments (domestic or foreign) involving the company's manufacturing facilities; the market adoption and demand of ABRAXANE and other products, the costs associated with the ongoing launch of ABRAXANE; research and development associated with the nab® technology platform; the impact of pharmaceutical industry regulation; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; the ability to successfully manufacture products in a time-sensitive and cost effective manner; the acceptance and demand of new pharmaceutical products; and the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in other documents it has filed with the Securities and Exchange Commission.
The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
About Abraxis BioScience
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes chemotherapeutic compound (ABRAXANE®), which is based on the company's proprietary tumor targeting technology known as the nab® platform. The first FDA approved product to use this nab® platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer and is now approved in 39 countries. The company continues to expand the nab® platform through a robust clinical program and deep product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol ABII.
ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Abraxis BioScience's proprietary nab® technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel. ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma, pancreatic and gastric.
The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. For the full prescribing information for ABRAXANE please visit www.abraxane.com.
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