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International Phase III Registration Trial Beginning in Second Half 2007 Will Compare Weekly ABRAXANE Versus Taxotere Administered Every Three Weeks
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 ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) and Taxotere(R) (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 José Iglesias, M.D., Vice
President Global Clinical Development for Abraxis Oncology, a division of
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 IV 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
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%,
About Breast Cancer
Breast cancer is the most common cancer among Canadian women, and in
2007, an estimated 22,300 will be diagnosed with breast cancer and 5,300 will
die from the disease.
ABRAXANE(TM) for Injectable Suspension (paclitaxel powder for injectable
suspension) (nanoparticle, albumin-bound (nab(TM)) paclitaxel) received
approval in June 2006 from the Therapeutic Products Directorate of Health
Canada under a Notice of Compliance for the treatment of metastatic breast
cancer in Canada. Canada is the first major commercial market to grant an
approval for ABRAXANE(TM) that includes first-line treatment of metastatic
breast cancer. The U.S. Food and Drug Administration approved ABRAXANE(TM) in
January 2005. For the full prescribing information for ABRAXANE(TM) please
visit http://www.abraxane.com .
About Abraxis Oncology
Abraxis Oncology, a wholly owned division of Abraxis BioScience Inc., is
devoted to the global development and commercialization of next generation
cancer therapies. The Canadian affiliate of Abraxis Oncology is located in
Richmond Hill, Ontario. For more information about the division and its
products, please visit http://www.abraxisoncology.com .
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-
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-, was launched in 2005 for
the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Stock
Market under the symbol ABBI. For more information about the company and its
products, please visit http://www.abraxisbio.com .
Taxotere(R) is a registered trademark of Sanofi Aventis.
For more information, please click here
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