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Aranesp Phase 3 Study in Patients with Active Cancer Not Receiving,Concurrent Chemotherapy or Radiotherapy Presented at AACR Annual,Meeting

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Apr 16, 2007 - Amgen (Nasdaq:AMGN) today presented the results from a randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of Aranesp(R) (darbepoetin alfa) for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy ("the 103 study"). Aranesp is not approved for use by the FDA or EMEA in these patients. These results were presented in an oral session at the 2007 American Association for Cancer Research (AACR) annual meeting in Los Angeles, Calif. (AACR Abstract #LB-3).

As reported in January, the study did not meet its primary endpoint of reducing red blood cell (RBC) transfusions in the Aranesp treatment group. Transfusion occurrences from weeks 5 to 17 favored Aranesp but were not statistically significant between the groups (hazard ratio: 0.85, p=0.32). Among those receiving Aranesp, there was a significantly higher proportion of patients with a hemoglobin response (p less than 0.0001), hemoglobin correction (p less than 0.001), and hematopoietic response (p=0.002) compared with placebo.

The adverse event rate was similar between the groups. However, the overall number of deaths was greater in the Aranesp group (48.5 percent versus 46 percent in placebo; hazard ratio: 1.29; p=0.006). In post-hoc analyses adjusting for stratification factors at randomization and sex, stage IV disease, prior chemotherapy use and prior radiotherapy use, there remained a significant difference in survival between the groups. However, hazard ratios and statistical significance diminished when the analyses were further adjusted for known prognostic factors including baseline ECOG status, tumor type, tumor stage, baseline FACT-F cutoff at median and baseline Hb (hazard ratio: 1.17, p=0.11).

"This study evaluated ESA treatment for patients with active cancer, not receiving chemotherapy or radiation
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