Combination Therapy of Solvent-Free Abraxane and the Targeted Therapy Bevacizumab Evaluated as First-Line Treatment for Metastatic Breast CancerCHICAGO--(BUSINESS WIRE)--Jun 2, 2008 - Abraxis BioScience, Inc. (NASDAQ:ABII), 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. US Oncology supports one of the nation's foremost cancer treatment and research networks accelerating the availability and use of evidence-based medicine and shared best practices.
US Oncology's expertise in supporting every aspect of the cancer care delivery system - from drug development to treatment and outcomes measurement, enables the company to help increase the efficiency and safety of cancer care. According to the company's last quarterly earnings report, US Oncology is affiliated with 1,247 physicians operating in 472 locations, including 91 radiation oncology facilities in 39 states. For more information, visit the company's Web site, www.usoncology.com.
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. Since 1993, more than 32,000 patients have participated in clinical trials managed by US Oncology network practices. For more information, visit the "Research" section under "Our Services" on the company's Web site, www.usoncology.com.
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)
ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric, and head and neck. The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study for which FDA approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction. For the full prescribing information for ABRAXANE, including Boxed Warning, please visit www.abraxane.com.
ABRAXANE was developed by Abraxis BioScience and is marketed in the United States under a co-promotion agreement between Abraxis and AstraZeneca.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca-us.com.
About Abraxis BioScience
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes the world's first and only protein-bound chemotherapeutic compound (ABRAXANE), which is based on the company's proprietary tumor targeting technology known as the nab(TM) platform. The first FDA approved product to use this nab(TM) platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.
(i) Danso, Michael, et al. Phase 2 Trial of Weekly nab-paclitaxel in combination with bevacizumab as First-Line Treatment in Metastatic Breast Cancer (Abstract CA083). ASCO, 2008.
(ii) Detailed Guide: Breast Cancer What Are the Key Statistics for Breast Cancer? American Cancer Society. http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_ statistics_for_breast_cancer_5.asp.
(iii) Detailed Guide: Advanced Cancer What Is Metastatic Cancer? American Cancer Society. http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Metastati c_Cancer.asp?sitearea=.
(iv) Data on file. DA-ABR-03, Abraxis Bioscience, Inc
(v) ACS Cancer Facts & Figures 2008
(vi) Ries LAG, Melbert D, Krapcho M, et al., eds. SEER Cancer Statistics Review, 1975-2004, National Cancer Institute. Bethesda, MD, Available online.
(vii) Abraxane (package insert). Los Angeles, Calif: Abraxis BioScience, Inc., August 2007.
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Posted: June 2008