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news.Amgen has revealed disappointing interim results from a Phase III study of Aranesp in 733 neoadjuvant breast cancer patients receiving dose-dense, dose-intense preoperative chemotherapy compared to a standard preoperative chemotherapy regimen.
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The pre-specified interim Phase III (Prepare study) results relate to the study period when chemotherapy and Aranesp were administered, and specifically address the tumor response to chemotherapy at the time of surgery. In this analysis, there was no significant difference between the Aranesp and control groups.
The primary long-term follow up endpoints of the Prepare study, including relapse-free survival time and overall survival, were designed to be analyzed when a pre-specified number of events had been observed. The study showed numerically more deaths (37/377 for control and 50/356 for Aranesp) and tumor progression events (70/377 for control and 88/356 for Aranesp) on the Aranesp arm compared to the control group in the long-term follow up. A formal statistical analysis of survival is anticipated in early 2009.