CHICAGO -- Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced the presentation of results from an ongoing single-arm, open-label, Phase II clinical trial evaluating solvent-free ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) in combination with bevacizumab for the first-line treatment of metastatic breast cancer. The preliminary analysis showed that ABRAXANE (ABI-007 or nab-paclitaxel) (125 mg/m2) given weekly for three weeks combined with bevacizumab (10 mg/kg) given weekly on the first and third week of a four-week treatment cycle demonstrated a 33 percent overall response rate and a median progression-free survival of 7.4 months. The findings were presented by US Oncology researchers today at the 44th Annual Meeting of the American Society of Clinical Oncology held May 30-June 3 in Chicago.
The U.S. Food and Drug Administration (FDA) approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
In the ongoing Phase II study, 50 women with previously untreated metastatic breast cancer have been treated with ABI-007 and bevacizumab. Results demonstrated an overall response rate of 33 percent for the 45 evaluable women, with 14 women experiencing a partial response to treatment and one patient achieving a complete response. Eighteen percent of women experienced stable disease for more than 16 weeks. The median progression-free survival for women treated with ABI-007 and bevacizumab was 7.4 months (95% confidence interval: 5.4, 9.2).(i)
"The preliminary results of this study show antitumor activity for nab-paclitaxel in combination with bevacizumab as a first-line treatment for metastatic breast cancer," said Dr. Michael Danso of Virginia Oncology Associates, an affiliated practice of US Oncology. "Though further study is warranted, the results demonstrate that this combination regimen is feasible." Dr. Danso is a member of the US Oncology Breast Cancer Research Committee.
About the Study
In the Phase II open-label study, 51 patients with HER-2 negative metastatic breast cancer were enrolled. To date, 50 patients have been treated for a mean of 4.0 treatment cycles, and 45 are evaluable for response. Forty-eight percent of patients received prior chemotherapy treatment, including 4 percent who received an anthracycline in the adjuvant setting. An additional 14 percent of patients received docetaxel and 14 percent were treated with paclitaxel in the adjuvant setting.(i)
In the study combining weekly ABI-007 and bevacizumab, the most common hematologic adverse events (grade three and four) were neutropenia (34 percent and 16 percent, respectively), leukocytopenia (27 percent and 7 percent, respectively) and anemia (7 percent and 5 percent, respectively). The most common non-hematologic adverse events were alopecia, nausea, fatigue and sensory neuropathy (54%, 52%, 48% and 48%, respectively).(i)
About Metastatic Breast Cancer
Breast cancer is a disease that will affect one in eight women during her lifetime.(ii) Metastatic breast cancer is defined as the spread of a malignant tumor from its original site (the breast) to other parts of the body.(iii) 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.(iv) Nearly all breast cancer deaths are attributable to advanced or metastatic breast cancer and it is estimated that every thirteen minutes a woman dies from the disease.(v) However, more women are surviving breast cancer than ever before(vi); the current five-year survival rate for women with metastatic breast cancer is 27 percent.(vi)
About US Oncology, Inc.
US Oncology, headquartered in Houston, works closely with physicians, manufacturers and payers to identify and deliver innovative services that enhance patient access to advanced cancer care.
About US Oncology Research
The US Oncology Research network is an established community-based research operation specializing in all phases of cancer clinical trials. The research network currently has 595 physicians actively enrolling patients, 109 research sites, and is currently involved in 63 open research trials. The network has contributed to the development of 24 of 30 of the latest cancer-fighting drugs approved by the Food and Drug Administration for use.
About ABRAXANE(R)
ABRAXANE(R) is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nab(TM) technology platform, ABRAXANE is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminate the need for solvents in the administration process. Because solvents are eliminated, ABRAXANE allows for the delivery of a 49% higher dose compared to solvent-based paclitaxel (Taxol(R)) without compromising safety and tolerability. In a previous randomized Phase III study of metastatic breast cancer patients, ABRAXANE demonstrated nearly double the overall tumor response rate compared to solvent-based paclitaxel.(vii)
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