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. 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 studyEpithelium 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>" 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. 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.