New Data Shows Promising Antitumor Activity with nab-paclitaxel (ABRAXANE) in Combination and as a Single Agent for the Treatment of Lung and Ovarian Cancers
HOUSTON, June 04, 2007 /PRNewswire/ -- Leading cancer researchers affiliated with the US Oncology Research Network, one of the nation's largest cancer treatment and research networks focused on cancer treatment and research, and Abraxis BioScience, Inc. , an integrated, global biopharmaceutical company, presented preliminary findings from two investigator-initiated Phase II studies evaluating albumin-bound paclitaxel (nab-paclitaxel) in combination and alone for the treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC) and platinum-sensitive, recurrent ovarian, peritoneal or fallopian tube cancer, respectively. In both Phase II clinical studies, nab-paclitaxel, marketed under the brand name ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) was found to be well-tolerated with encouraging response rates, providing support for further investigation of nab-paclitaxel for the treatment of NSCLC and ovarian cancer. The study results were presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) held June 2 - 5, 2007 in Chicago.
The study titled "An open-label, Phase II trial of nab-paclitaxel, carboplatin and bevacizumab in first-line patients with advanced non-squamous non-small cell lung cancer (NSCLC)" (Abstract number 7610) was presented by principal investigator, Craig H. Reynolds, M.D. of Ocala Oncology Center, Ocala, Florida, who also serves as co-chair of US Oncology's National Lung Cancer Research Committee. The randomized, open-label Phase II study was designed to evaluate nab-paclitaxel dosed every three weeks in combination with carboplatin and bevacizumab in 50 patients with advanced non-squamous NSCLC.
"The use of nab-paclitaxel has circumvented many of the infusion difficulties that are associated with solvent-based paclitaxel," said Dr. Reynolds. "Preliminary analysis of this study indicates that treatment with nab-paclitaxel in combination with carboplatin and bevacizumab was not only well-tolerated, but showed encouraging response and median survival rates in the first-line treatment of non-small cell lung cancer."
The primary end point of the study was response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Responding patients received at least four cycles of treatment. Thirty-six patients completed all four cycles of therapy. So far, 31.3 percent of patients showed a partial response and 52.1 percent had stable disease. Kaplan-Meier estimated median progression free survival (PFS) was 9.8 months, and median survival was 15.8 months. Grade 3-4 treatment-related toxicities were: neutropenia 52 percent; fatigue 17 percent; febrile neutropenia, thrombocytopenia and neuropathy 10 percent each; and anorexia, constipation, and diarrhea 4 percent each.
The study titled "Results of a Phase II evaluation of nab-paclitaxel in platinum-sensitive patients with recurrent ovarian, peritoneal or fallopian tube cancer" (Abstract number 5525) was presented in a poster presentation by the principal investigator, Michael G. Teneriello, M.D. of Texas Oncology, who also serves as co-chair of US Oncology's National GU/Gyn Research Committee. This open level Phase II study was designed to evaluate single agent nab- paclitaxel in a platinum-sensitive patient population. A total of 47 patients were enrolled for treatment with nab-paclitaxel every three weeks at \ 260 milligrams per meter(2).
"The study results show that nab-paclitaxel as a single agent is very active and well-tolerated in patients with recurrent ovarian cancer," said Dr. Teneriello. "There are multiple treatment options for patients with this difficult to treat disease, but the results of this study are very encouraging. Further studies with nab-paclitaxel in combination with platinum as a first-line therapy for recurrent ovarian cancer are warranted."
Patients received nab-paclitaxel intravenously once every three weeks until progressive disease or until completion of six cycles, with two additional cycles if a complete response was observed. Disease progression was measured by RECIST criteria or elevated blood levels of the biological marker CA-125 in the absence of measurable disease. For all eligible/treated patients, the overall response rate was 63.6 percent with 14 complete and 14 partial responses out of 44 evaluable patients. Median duration of response of was 6.5 months with a median progression free survival of 8.5 months. The most frequent Grade 3-4 treatment-related toxicities were: neutropenia 23.9 percent; leucopenia 13 percent; and neuropathy 8.7 percent.
"Both studies demonstrated ABRAXANE's activity and tolerability, as a single agent for ovarian cancer and in combination for non-small cell lung cancer," commented Michael Hawkins, M.D., Chief Medical Officer, Abraxis BioScience. "Studies of ABRAXANE in various tumor types, such as these done by US Oncology Research, are continuing to expand of our collective clinical experience with ABRAXANE."
This research was supported, in part, by a research grant from Abraxis BioScience, Inc.
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 528 physicians actively enrolling patients, 82 research sites, and is currently involved in 65 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, http://www.usoncology.com.
About US Oncology, Inc.
US Oncology, headquartered in Houston, is one of the nation's largest cancer treatment and research networks. US Oncology provides extensive services and support to its affiliated cancer care sites nationwide to help them expand their offering of the most advanced treatments and technologies, build integrated community-based cancer care centers, improve their therapeutic drug management programs, and participate in many of the new cancer-related clinical research studies. US Oncology also provides a broad range of services to pharmaceutical manufacturers, including product distribution and informational services such as data reporting and analysis.
According to the company's last quarterly earnings report, US Oncology is affiliated with 1,077 physicians operating in 433 locations, including 90 radiation oncology facilities in 38 states.
The U.S. Food and Drug Administration approved ABRAXANE.(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 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. 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(R), please visit http://www.abraxane.com.
ABRAXANE was developed by Abraxis BioScience, Inc. ABRAXANE is marketed in the United States under a co-promotion agreement between Abraxis BioScience, Inc. and AstraZeneca Pharmaceuticals LP.
About Abraxis BioScience, Inc.
Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab(TM) (nanoparticle albumin bound) platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANE(R), was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on The Nasdaq Global Market under the symbol ABBI. For more information about the company and its products, please visit http://www.abraxisbio.com. ABRAXANE(R) is a registered trademark of Abraxis BioScience, Inc.
CONTACT: Kimberly Rutherford, +1-832-601-6193, or Elizabeth Vocke,+1-813-240-0791, both of US Oncology, or Christine Cassiano of AbraxisBioScience, +1-310-405-7417
Ticker Symbol: (NASDAQ-NMS:ABBI)
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Posted: June 2007