EndocrinologyAbraxis Bioscience Completes Enrollment Of Pivotal Phase III Advanced Lung Cancer Study Evaluating Abraxane(R) Vs. Taxol(R)
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, announced that the company has completed patient enrollment of a pivotal, phase III clinical study comparing the company"s chemotherapy agent ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) with Taxol® (paclitaxel) injection, both in combination with carboplatin, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). The study, which is being conducted at 111 sites globally, includes 1,050 patients and is being led by principal investigator Dr. Mark Socinski at the University of North Carolina Lineberger Comprehensive Cancer Center. It is one of the largest NSCLC clinical studies to complete enrollment.
"The completion of enrollment of this phase III study marks a significant milestone in our efforts to evaluate ABRAXANE for the treatment of patients with metastatic lung cancer," said Lonnie Moulder, President and Chief Executive Officer of Abraxis BioScience, Inc. "We anticipate filing a supplemental new drug application (sNDA) with the FDA in the first half of 2010 for what will be the second indication for ABRAXANE."
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.
NSCLC comprises 85 to 90 percent of lung cancers. Lung cancer is the leading cause of cancer death, and treatment options for patients are limited.[1]
Study Design
The phase III study involves 1,050 patients randomized in a one-to-one ratio to two treatment arms: patients in Arm A (n=525) receive ABRAXANE 100 mg/m2 weekly plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle; and patients in Arm B (n=525) receive Taxol 200 mg/m2 weekly plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle. The primary study endpoint is disease response, measured as complete and partial responses as defined by RECIST (Response Evaluation Criteria in Solid Tumors). Secondary study endpoints include: safety and tolerability; disease control rate and duration of response; progression-free survival (PFS); patient survival; and assessments of ABRAXANE efficacy correlated with specific tumor biomarkers, including secreted protein acidic and rich in cysteine (SPARC).
About ABRAXANE
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 http://www.abraxane.com.
[1] Detailed Guide: Lung Cancer - Non-Small Cell. American Cancer Society Web site. 2009. http://www.cancer.org/docroot/CRI/CRI_2_3x.asp?rnav=cridg&dt=15. Accesses July 9, 2009.
Abraxis BioScience, Inc.