Healthcare Industry News: sanofi-aventis
News Release - June 2, 2007
ABRAXANE Demonstrates Longer Progression-Free Survival versus Taxotere in the Treatment of First-Line Metastatic Breast CancerInternational Phase III Registration Trial Beginning in Second Half 2007 Will Compare Weekly ABRAXANE Versus Taxotere Administered Every Three Weeks
CHICAGO--(HSMN NewsFeed)--Abraxis BioScience, Inc. (NASDAQ:ABBI ), an integrated, global biopharmaceutical company, today announced the presentation of updated results from an ongoing open-label, randomized head-to-head Phase II clinical trial comparing ABRAXANEŽ for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) and TaxotereŽ (docetaxel) in the first-line treatment of metastatic breast cancer. The updated analysis demonstrated that ABRAXANE administered weekly (150 mg/m2) and every three weeks (300 mg/m2) resulted in longer progression-free survival and an overall improved toxicity profile compared to Taxotere administered every three weeks (100 mg/m2). ABRAXANE administered weekly (100 mg/m2) resulted in comparable progression-free survival and significantly less toxicity compared to the Taxotere arm. The findings were presented today at the 43rd Annual Meeting of the American Society of Clinical Oncology held June 1-5, in Chicago.
"As physicians, when selecting a treatment regimen, we look to improve progression-free survival while minimizing toxicity to offer the best outcome for our patients," said William Gradishar, M.D., F.A.C.P., Director, Breast Medical Oncology at Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Ill., co-lead investigator of the study. "We are encouraged by the results that demonstrate that weekly treatment with ABRAXANE is well tolerated and may increase progression-free survival compared to every three week administration of Taxotere."
Based on these data, Abraxis BioScience plans to initiate a global multi-center head-to-head Phase III registration trial comparing the ABRAXANE at the 150 mg/m2 dose administered weekly to Taxotere at the 100 mg/m2 dose administered every three weeks for the first-line treatment of metastatic breast cancer. The trial is planned to begin in the second half of 2007 and will take place in multiple sites throughout North America, Eastern and Western Europe, and Asia-Pacific.
"The updated analysis continues to show that all three ABRAXANE regimens demonstrate an improved toxicity profile compared to Taxotere, with longer or comparable progression-free survival," said Michael Hawkins, M.D., chief medical officer, Abraxis BioScience. "We now look forward to confirming these promising findings in our upcoming Phase III registration trial."
About the Study
In the randomized Phase II study, 300 patients with stage 4 metastatic breast cancer and no prior chemotherapy treatments received one of four treatment regimens: ABRAXANE 300 mg/m2 (n= 76) dosed every three weeks, ABRAXANE 100 mg/m2 (n= 76) or 150 mg/m2 (n= 74) dosed weekly for three weeks out of four, and Taxotere 100 mg/m2 (n= 74) dosed every three weeks. The purpose of the study was to obtain comparative toxicity and anti-tumor response data for ABRAXANE versus Taxotere. The secondary endpoint of the study was progression-free survival.
First-line treatment with ABRAXANE demonstrated a reduction in the risk of progression for ABRAXANE by 54 percent and 37 percent (150 mg/m2 weekly, p=0.002; and 300 mg/m2 q3w, p=0.046, respectively), both compared to Taxotere (100 mg/m2 q3w).
Results from a planned independent radiology review were also presented. These results demonstrated a strong correlation between investigator findings for response rate and progression-free survival and assessments made by independent radiology review. Radiologists were blinded to treatment assignment, investigator assessment of response, and target lesions selected by investigator.
Overall, the three ABRAXANE treatment arms (300 mg/m2 q3w, 100 mg/m2 wkly, 150 mg/m2 wkly) demonstrated less frequent adverse events in terms of Grade 4 neutropenia, febrile neutropenia, and fatigue as compared to the Taxotere arm (100 mg/m2 q3w). The incidence of Grade 4 neutropenia for all three ABRAXANE arms was significantly less as compared to the Taxotere arm (5%, 5%, 9% ABRAXANE vs. 75% Taxotere, respectively). Febrile neutropenia was also lower in all three ABRAXANE treatment arms as compared to the Taxotere arm (1%, 1%, 1% ABRAXANE vs. 8% Taxotere, respectively). Additionally, fatigue was significantly lower in all three ABRAXANE arms compared to Taxotere (ABRAXANE 35%, 31%, 42%, vs. Taxotere 56%, respectively).
There was no grade 4 peripheral neuropathy reported in any of the treatment arms. There were no statistical differences in peripheral neuropathy between the ABRAXANE regimens compared to Taxotere. In an unplanned analysis, peripheral neuropathy improved more rapidly with all three ABRAXANE arms (300 mg/m2 q3w, 100 mg/m2 wkly, 150 mg/m2 wkly) as compared to the Taxotere arm (16 days, 22 days, 23 days ABRAXANE vs. 41 days Taxotere, respectively).
Arthralgias occurred with greater frequency in the ABRAXANE weekly (150 mg/m2) and every three week (300 mg/m2) arms compared to the Taxotere arm (33%, 35% vs. 17%, respectively). The ABRAXANE weekly (100 mg/m2) arm demonstrated comparable arthralgias to the Taxotere arm (18% vs. 17%, respectively; p=0.551).
About Breast Cancer
According to the American Cancer Society, breast cancer is the most common cancer among women, other than skin cancer, and is the second leading cause of cancer death in women in the United States. The risk of having breast cancer for a woman sometime during her life is about one in eight. In 2007, an estimated 240,510 new cases of invasive breast cancer are expected to occur in women, and an estimated 40,460 women are expected to die from invasive breast cancer.
The U.S. Food and Drug Administration approved ABRAXANEŽ 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 ABRAXANEŽ, please visit 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) 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, ABRAXANEŽ, 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 www.abraxisbio.com.
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the planned global multi-center head-to-head Phase III registration trial comparing ABRAXANE to Taxotere. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the continued market adoption and demand of ABRAXANE in North America and its potential market penetration outside of the U.S., the success of our co-promotion agreement with AstraZeneca, the fact that results from earlier clinical studies may not be predictive of results to be obtained in future clinical trials, delays in commencement and completion of clinical trials, including slower than anticipated patient enrollment and adverse events occurring during the clinical trials, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in Abraxis BioScience's Form 10-K for the year ended December 31, 2006 and other documents it has filed with the Securities and Exchange Commission.
The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
TaxotereŽ is a registered trademark of sanofi-aventis.
Source: Abraxis BioScience
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