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Interim Data from Phase II Trial Presented at 44th Annual Meeting of the American Society of Clinical Oncology
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 trastuzumab and carboplatin for the first-line treatment of patients with HER2-positive metastatic breast cancer. The preliminary analysis showed that weekly ABRAXANE (ABI-007 or nab-paclitaxel) (100 mg/m2 three weeks on treatment, one week off) followed by carboplatin (AUC of 6 every four weeks) plus trastuzumab (4 mg/kg loading dose followed by 2 mg/kg on subsequent visits) demonstrated a 53 percent overall response rate and median progression free survival of nearly 16 months. The findings were presented 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, 32 patients were treated with a regimen of ABI-007 given weekly three weeks out of four, carboplatin given once every four weeks and trastuzumab given once a week on a four-week treatment cycle. Thirty patients are evaluable for response and eight patients continue to receive treatment. The combination of weekly ABI-007, trastuzumab and carboplatin resulted in a median progression-free survival of 15.9 months (95% confidence interval, 7-28 months). In addition, 14 patients had a confirmed partial response and 2 patients had a complete response, and 30 percent of patients experienced stable disease for more than 16 weeks.
"We observed anti-tumor activity for the combination of nab-paclitaxel administered together with carboplatin and trastuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer," said Andrew. D. Seidman, M.D., Attending Physician, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center and Professor of Medicine, Weill Medical College of Cornell University. "With 53 percent of patients responding to treatment and a median progression-free survival of nearly 16 months, the results demonstrate this regimen deserves to be further examined in larger clinical studies."
About the Study
The Phase II study included 32 patients with HER2-positive metastatic breast cancer with a median age of 52 years. Sixty-six percent of patients treated had visceral-dominant metastatic breast cancer. Nearly half of all the patients had received prior adjuvant or neoadjuvant chemotherapy, and 34 percent were treated with a taxane. Seventy-eight percent of patients were post-menopausal.i
An initial cohort of three patients received ABI-007 at a dose of 75 mg/m2 followed by carboplatin (AUC of 2) once a week for three weeks plus weekly trastuzumab (4mg/kg load and 2 mg/kg on all subsequent weeks) on a four-week treatment cycle for one full cycle. This schedule was well-tolerated and ABI-007 was escalated to 100 mg/m2 for all subsequent cycles and patients. Due to hypersensitivity reactions attributed to weekly carboplatin in four of the first 13 patients treated, carboplatin dosing was changed to once every four weeks (AUC of 6) for the 17 subsequent patients. The combination therapy was continued until progressive disease, unacceptable toxicity or for six cycles with the option of continuing trastuzumab alone at investigator discretion. The mean number of treatment cycles administered was 6.7 (range of 1-16) and the relative dose intensity for ABRAXANE was 80 percent. i
The grade 4 toxicities reported were neutropenia (13 percent), leukopenia (3 percent), anemia (3 percent) and thrombocytopenia (3 percent). Less than half of patients treated experienced grade 3 neutropenia (41 percent). Neuropathy was mild and infrequent, with three percent of patients experiencing grade 3 and 13 percent reporting grade 2. The only other non-hematologic grade 3 toxicity was fatigue (6 percent). Hypersensitivity reactions to carboplatin were noted in only one of 17 patients receiving carboplatin monthly and efficacy did not appear to be dependent on the carboplatin treatment schedule.i
"The study evaluating nab-paclitaxel in this regimen follows prior studies that demonstrated an advantage of adding carboplatin to solvent-based paclitaxel and trastuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer," said Dr. Seidman. "It also builds upon the significant findings of other randomized trials that have demonstrated superiority of a weekly schedule of solvent-based paclitaxel over an every three week schedule. By using a solvent-free formulation of paclitaxel in this study—nab-paclitaxel--routine anti-allergic premedication is unnecessary. In the absence of pre-medication, we also found that we were able to reduce the likelihood of allergic hypersensitivity reactions to carboplatin by giving the drug once a month."
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 beforevi; the current five-year survival rate for women with metastatic breast cancer is 27 percent.vi
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.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.
i Siedman, M.J., et al. Phase II study of weekly nanoparticle albumin bound (nab) paclitaxel in combination with carboplatine and trastuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer (MBC) [Abstract CA016]. 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. (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)
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=. (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)
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.
About Abraxis BioScience, Inc.
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.
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