Abraxis BioScience Inc, an integrated, global biopharmaceutical company, has presented data in an oral presentation at the 29th Annual San Antonio Breast Cancer Symposium (SABCS) from an interim analysis of a randomised, head-to-head phase II trial of Abraxane for injectable suspension versus Taxotere injection concentrate, in the first-line treatment of metastatic breast cancer.
The interim analysis showed that first-line treatment with weekly Abraxane increased tumour response rate by greater than 60 per cent with less toxicity versus Taxotere given every three weeks in patients with metastatic breast cancer. The interim analysis also showed that weekly Abraxane nearly doubled the response rate with less toxicity compared to Abraxane dosed every three weeks.
Although the data are not fully mature, the interim analysis showed that all three Abraxane regimens currently have longer progression-free survivals than Taxotere dosed every three weeks. A blinded, independent radiological review of the response data is in process and the company intends to submit the final analysis of the data to the American Society of Clinical Oncology (ASCO) in 2007.
Based on these encouraging data, Abraxis plans to initiate a worldwide head-to-head phase III registration trial comparing weekly Abraxane to every three week Taxotere for the treatment of first-line metastatic breast cancer. The phase III registration trial is expected to begin in the first half of 2007 in multiple sites throughout North America, Eastern and Western Europe, and Asia-Pacific.
"These interim data show that weekly Abraxane, when used in the first-line treatment of patients with metastatic breast cancer, increased the response rate by over 60 per cent with less toxicity than the FDA-approved dose of Taxotere given every three weeks," said William Gradishar, MD, F A C P, Director, Breast Medical Oncology at Robert H. Lurie Comprehensive Cancer Centre Northwestern University, a lead investigator in the study. "These data are consistent with previous study results of both Abraxane and Taxotere, and are very encouraging for both physicians and patients."
"The high response rate to weekly Abraxane observed in this study is consistent with other data presented at this symposium by the NSABP Foundation Research Group and the International Oncology Network, and provides new insight into the clinical development of Abraxane," said Michael Hawkins, MD, chief medical officer of Abraxis BioScience. "The phase II results provide the direction needed to initiate a phase III trial examining weekly Abraxane versus Taxotere in first-line treatment of metastatic breast cancer. We look forward to presenting the final analysis of this Phase II study next year."