LOS ANGELES--(BUSINESS WIRE)--Abraxis BioScience Inc. (NASDAQ:ABII) announced today that final results from an open-label Phase II study evaluating three dose levels of the company’s chemotherapy agent ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) compared to the highest standard dose of Taxotere (docetaxel) Injection Concentrate, in the first-line treatment of patients with metastatic breast cancer were published in the Journal of Clinical Oncology. According to investigator-assessed results, ABRAXANE administered weekly at 150 mg/m2 demonstrated an increase in progression-free survival (PFS) over docetaxel of 14.6 months versus 7.8 months, respectively (p=0.012). Results from the independent assessment of PFS for the 150mg/m2 treatment arm also demonstrated an increase in PFS (12.9 versus 7.5 months, respectively; p=0.0065). Investigators also noted a trend toward improvement in the study’s primary endpoint, overall response rate (ORR), confirmed complete and partial responses by Response Evaluation Criteria in Solid Tumors (RECIST) criteria with weekly ABRAXANE. In investigator-assessed results, the ORR was 74 percent for ABRAXANE 150 mg/m2 weekly arm (p<0.001) and 63 percent for the weekly ABRAXANE 100 mg/m2 treatment arm (p=0.02), compared to a response rate of 39 percent for patients treated with docetaxel. However, improved ORR did not reach statistical significance in an independent radiological review of the data. Patients treated with weekly 150 mg/m2 ABRAXANE also experienced a higher disease control rate of 91 percent vs. 69 percent for the docetaxel arm (p=0.005), as measured by RECIST-defined stable disease (= 16 weeks) or confirmed partial or complete response. Additionally, patients treated with ABRAXANE experienced less overall toxicity than the docetaxel arm.
