The phase II study was assessing the optimal starting dose of Cera in anaemic patients with non-small cell lung cancer receiving first line chemotherapy.
However, Roche said treatment of enrolled patients with the drug Cera will continue. The investigators reported all deaths to be unrelated to the study drugs. Roche commented that there appears to be no association of these events to excessive haemoglobin levels or the administered doses based on the current review of the data.
Cera is part of a class of drugs that contain the natural protein erythropoietin (EPO) and which treats anemia by boosting the body’s production of red blood cells. Amgen has recently reported a higher death risk among patients taking its Aranesp drug which also contains EPO.
Roche believes the inconsistency in the death rate may be attributed to the fact that there were imbalances upon entry into the trial between the different arms in categories like the severity of tumor spread, presence of liver metastases and incidence of chronic obstructive pulmonary disease.
Roche is further investigating the potential causes for the imbalance across the arms in this population.