Abraxis BioScience Inc. (ABII), a California based global biotechnology company focusing on cancer treatments, announced today that its chemotherapeutic compound ABRAXANE® has demonstrated a significant improvement in overall response rate in the treatment of the most common form of lung cancer when compared to Taxol®, based upon independent radiologist review.
The study was a randomized registrational Phase 3 clinical trial comparing ABRAXANE (protein-bound paclitaxel) with Taxol (paclitaxel) injection, both in combination with carboplatin, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). One of the largest NSCLC clinical studies ever conducted, it involved over 1,000 patients, at 102 different sites around the world.
Mark Socinski, M.D., of the University of North Carolina Lineberger Comprehensive Cancer Center, the principal investigator, said of the study, “This is exciting news for lung cancer patients and has important implications not only in late stage cancer but also in earlier stages of the disease. The data will be submitted for consideration as a late breaking presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting”.
Patrick Soon-Shiong, M.D., Executive Chairman and founder of Abraxis BioScience, added, “NSCLC is the most common form of lung cancer and is very difficult to treat. We are extremely pleased with the data from this Phase 3 combination study that demonstrated superiority of ABRAXANE over Taxol as we seek to bring new treatment options to these patients. We anticipate filing an sNDA (supplemental new drug application) to the FDA during 2011 for what will be the second indication for ABRAXANE in the U.S.”
NSCLC accounts for approximately 85% of all lung cancer cases, resulting in roughly 159,000 U.S. deaths annually. The American Cancer Society estimates that over 219,000 people were diagnosed with lung cancer in 2009. ABRAXANE is now in various stages of investigation for the treatment of other cancers as well, including expanded applications for metastatic breast cancer, malignant melanoma, pancreatic and gastic cancers. ABRAXANE, which is based on the company’s proprietary tumor targeting technology known as the nab® platform, has already been approved in 39 countries for the treatment of metastatic breast cancer.