Amgen's (AMGN) Aranesp "145 Study'' Shows No Difference in Survival in Patients with Small-Cell Lung Cancer

April 19, 2007 9:30 AM EDT

Amgen (NASDAQ: AMGN) announced the results of the "145 study", a randomized, double-blind, placebo-controlled, multicenter Phase 3 study of AranespĀ® (darbepoetin alfa) in 600 previously untreated patients with extensive-stage small-cell lung cancer (SCLC) receiving platinum-containing chemotherapy. The study demonstrated no statistically significant difference in risk of death.

The study demonstrated a significant change in hemoglobin concentration from baseline in favor of Aranesp (a co-primary endpoint). Aranesp-treated patients also experienced a significantly lower risk of blood transfusions (HR: 0.40, 95% CI: 0.29 to 0.55). The overall safety profile, including thromboembolic events, was consistent with that described in the U.S. label.


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