The pancreatic trial results follow recent findings from a phase 1/2 study of nab-paclitaxel in combination with gemcitabine, which demonstrated increased survival in first-line treatment of patients with advanced pancreatic cancer. Presented at the 101st Annual Meeting of the American Association for Cancer Research (AACR) in April 2010, median OS for 44 patients treated at the recommended dose of 125 mg/m2 nab-paclitaxel plus gemcitabine (1000 mg/m2) was 12.2 months, a doubling of survival compared to historical control of gemcitabine alone. ABRAXANE has been granted orphan drug designation by the Food and Drug Administration for the treatment of pancreatic cancer as well as stage IIB-IV melanoma. Enrollment is ongoing for a phase 3 trial program evaluating nab-paclitaxel plus gemcitabine versus gemcitabine alone as a first-line therapy for advanced metastatic pancreatic cancer.
"The success of ABRAXANE in patients with pancreatic cancer supports our belief and understanding of how the nab-driven chemotherapy leverages the tumor biology against itself to increase efficacy," said Patrick Soon-Shiong, M.D., Executive Chairman and founder of Abraxis BioScience. "We believe ABRAXANE exploits the albumin-binding protein receptor, Gp60, to penetrate the blood-stroma barrier in essence opening a portal to the tumor micro-environment, enabling the delivery of targeted cytotoxic agents leading to stromal collapse and tumor penetration."
Pancreatic cancer can be particularly hard 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. 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 outcomes.
SOURCE Abraxis BioScience, Inc.