Combination Therapy of Solvent-free Abraxane and the Targeted Therapy Bevacizumab Evaluated as First-line Treatment for Metastatic Breast Cancer
– Interim Data from Phase II Trial Presented at 44th Annual Meeting of the American Society of Clinical Oncology –
CHICAGO, IL – June 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® 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).
“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. Metastatic breast cancer is defined as
the spread of a malignant tumor from its original site (the breast)
to other parts of the body. 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. 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. However, more women are surviving breast cancer than
ever before ; 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.
About ABRAXANE®
ABRAXANE® is a solvent-free chemotherapy treatment option for
metastatic breast cancer. Developed using Abraxis BioScience's
proprietary nabTM 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®) 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.
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.
About 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 nabTM platform. The first FDA approved
product to use this nabTM 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.
Contacts:
Abraxis BiosScience, Inc. AstraZeneca
Daniel Saks Donna Huang
310-405-7417 302-885-6396
DSaks@abraxisbio.com
donna.huang@astrazeneca.com
Investor and Media Inquiries Media Inquiries
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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.
[1] 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.
[1] Detailed Guide: Advanced Cancer What Is Metastatic Cancer? American Cancer Society. http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Metastatic_Cancer.asp?sitearea=.
[1] Data on file. DA-ABR-03, Abraxis Bioscience, Inc
[1] ACS Cancer Facts & Figures 2008
[1] Ries LAG, Melbert D, Krapcho M, et al., eds. SEER Cancer Statistics Review, 1975-2004, National Cancer Institute. Bethesda, MD, Available online.
[1] Abraxane [package insert]. Los Angeles, Calif: Abraxis BioScience, Inc., August 2007.
Posted: June 2008
