Amgen presents negative anaemia drug trial results

Amgen has presented the results of a phase III clinical trial of Aranesp (darbepoetin alfa) as a treatment for anaemia in cancer patients not being administered with radiotherapy or chemotherapy.

Presenting the results at the annual meeting of the American Association for Cancer Research in Los Angeles, the company reiterated its report from January, noting that the compound did not reduce red blood cell transfusions, thus failing to meet its primary endpoint.

Aransep is currently approved by the US Food and Drug Administration as a treatment for anaemia related to chronic renal failure, in addition to chemotherapy-induced anaemia in patients with non-myeloid malignancies.

The compound is not approved in the US or Europe for active cancer patients not receiving radiotherapy or chemotherapy.

John Glaspy, professor at the David Geffen School of Medicine at the University of California, said: “This study evaluated ESA [erythopoiesis-stimulating agent] treatment for patients with active cancer not receiving chemotherapy or radiation who are anaemic due to the cancer itself.”

He added that the benefit of this treatment was unfortunately not seen in this patient group, while there was “no clear explanation” for the 2.5 per cent increase in death rate in patients administered with Aransep compared to those receiving a placebo.

Last month, Amgen announced that it had discontinued the use of Vectibix (panitumumab) in an investigation assessing the safety and efficacy of the compound as a treatment for first-line metastatic colorectal cancer following a preliminary review of trial data.