Public Health

New Study Results Published Compare ABRAXANE(R) To Taxotere(R)

Abraxis BioScience Inc. (NASDAQ:ABII) announced 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 (pAbout the Study This Phase II, open-label, randomized clinical study was designed to evaluate the safety and efficacy of three doses of ABRAXANE against the highest standard dose of docetaxel. The study involved 300 patients with previously untreated metastatic (stage 4) breast cancer who were randomized to four treatment arms: ABRAXANE 150 mg/m2 administered every week (n=74); ABRAXANE 100 mg/m2 administered every week (n=76); ABRAXANE 300 mg/m2 administered once every three weeks (n=76); and docetaxel injection 100 mg/m2 administered once every three weeks (n=74). Results were assessed by both study investigators and an independent radiology review of radiological data. The primary study endpoint was overall response rate (ORR), defined as the percentage of patients that achieved an objective confirmed overall complete or partial response (CR or PR, respectively) based on RECIST guidelines. Secondary efficacy endpoints included disease control rate (DCR; stable disease for т‰Ґ16 weeks, or confirmed overall PR or CR), progression-free survival (PFS; defined as the time from date of randomization to the start of disease progression or death), duration of response (measured as PFS for patients who achieved confirmed CR or PR) and patient survival. The safety and tolerability study endpoints included the incidence of treatment-emergent and treatment-related adverse events (TRAEs) and serious adverse events. Progression Free Survival ABRAXANE 150 mg/m2 administered weekly demonstrated a statistically and clinically significant longer median PFS compared with docetaxel injection for both the investigator (14.6 versus 7.8 months, respectively; p=0.012) and independent radiologist (12.9 versus 7.5 months, respectively; p=0.0065) assessed results. Weekly ABRAXANE 100mg/m2 also prolonged median PFS as assessed by the independent radiologist review (12.8 versus 7.5 months, respectively; p=0.0498), but this result was not confirmed by the investigator assessment. ABRAXANE administered 300 mg/m2 every three weeks increased median PFS compared with docetaxel for both the independent radiologist (median, 11.0 versus 7.5 months, respectively) and investigator (median, 10.9 versus 7.8 months, respectively) assessed results, but did not meet statistical significance. Response Rate Based on independent radiologist review, the ORR for the 150 mg/m2 and 100 mg/m2 dose arms and docetaxel were 49 percent, 45 percent, and 35 percent respectively. Investigator assessments of the ORR were higher for the weekly ABRAXANE arms versus docetaxel injection with rates of: 74 percent for the 150 mg/m2 ABRAXANE arm (pDisease Control Based on both the investigator reviews and independent radiologist, the DCR was significantly higher for patients receiving 150 mg/m2 weekly ABRAXANE compared with docetaxel. The investigator-assessed DCR for the weekly 150 mg/m2 arm was 91 percent (p=0.005) and the DCR for the weekly 100 mg/m2 arm was 83 percent (p=0.009). These results were confirmed in the independent radiologist assessment with a statistically significant comparison for both the weekly ABRAXANE 150 mg/m2 (80 percent, p=0.017) and 100 mg/m2 (75 percent, p=0.009) compared to docetaxel injection (58 percent). Tolerability The published study reported that the weekly ABRAXANE treatment arms overall demonstrated a favorable safety and tolerability profile compared with docetaxel. Patients treated with ABRAXANE experienced less frequent grade 3/4 treatment-related adverse events including neutropenia, febrile neutropenia and fatigue. The rate of grade 4 neutropenia was 75 percent for patients treated with Taxotere compared to a rate of 5 percent for patients treated with weekly ABRAXANE 150 mg/m2 and 100 mg/m2. Febrile neutropenia also occurred more frequently in patients receiving Taxotere (eight percent versus one percent in each ABRAXANE treatment arm). The incidence of sensory neuropathy was comparable between the weekly ABRAXANE doses and Taxotere, however sensory neuropathy resolved more rapidly after treatment with ABRAXANE. In particular, the median time to improvement in grade 3 sensory neuropathy (to т‰¤ grade 1) was 22, 22, and 19 days, respectively, for patients who received ABRAXANE 300 mg/m2 q3w, 100 mg/m2 weekly, and 150 mg/m2 weekly compared with 37 days for patients who received docetaxel 100 mg/m2 q3w. Fatigue was more common and more severe in the Taxotere arm (19 percent of patients experienced grade 3/4 fatigue in the Taxotere arm compared to five percent for the ABRAXANE 300 mg/ m2 arm, zero percent for the ABRAXANE 100 mg/m2 arm and three percent on the ABRAXANE 150 mg/m2 arm). Incidences of arthralgia (grade 1/2) were comparable between patients who received Taxotere or weekly ABRAXANE 100 mg/m2 (22 percent and 19 percent, respectively). Thirty-two percent of patients reported arthralgia of any grade on the 300 mg/m2 ABRAXANE arm and 35 percent experienced arthralgia on the ABRAXANE 150 mg/m2 arm. About Metastatic Breast Cancer Breast cancer is a disease that will affect one in eight women during her lifetime.i Metastatic breast cancer is defined as the spread of a malignant tumor from its original site (the breast) to other parts of the body.ii It is estimated that nearly 155,000 women in the U.S. are currently living with metastatic breast cancer and this number is projected to increase to nearly 162,000 by the year 2011.iii Nearly all breast cancer deaths are attributable to advanced or metastatic breast cancer, and it is estimated that every 13 minutes a woman dies from the disease.iv However, more women are surviving breast cancer than ever beforev; the current five-year survival rate for women with metastatic breast cancer is 27 percent.vi ABRAXANE®

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