No chemo benefit with Amgen's Aranesp

US biotechnology major Amgen presented its analysis of the terminated DAHANCA 10 study of its drug Aranesp (darbepoetin alfa) at the 14th European Cancer Conference, held in Barcelona, Spain. The trial was stopped on November 28, 2006, due to futility following an interim analysis, which showed low likelihood that the Aranesp arm would demonstrate improved outcomes.

This independent, investigator-sponsored study is a component of Amgen's ongoing Aranesp pharmacovigilance program and was designed to evaluate the clinic benefit, if any, of using Aranesp to maintain hemoglobin levels between 14.0g/dL to 15.5g/dL results in better outcomes for patients with squamous cell carcinoma of the head and neck by allowing more oxygen to reach the tumor, making it more sensitive to radiotherapy. Aranesp is not indicated for concomitant treatment with radiotherapy alone and the Hb targets in this study exceeded the current approved labeling in both Europe and the USA.

The study investigators completed their analysis and have concluded that patients with primary HNSCC who were treated with Aranesp had significantly-poorer tumor control after radiotherapy. Of 515 eligible for analysis, the results demonstrated a poorer outcome with Aranesp treatment in five-year loco-regional control (56% with Aranesp versus 69% for the control group; p=0.02), the primary endpoint for the study.