Janssen-Cilag reports positive Dacogen trial data

Janssen-Cilag has highlighted new data from a clinical trial of Dacogen that demonstrates its survival benefits for older patients with acute myeloid leukaemia (AML).

In the DACO-016 phase III trial, the drug was compared to either supportive care or low-dose cytarabine among patients aged 65 years and above with newly diagnosed de novo or secondary AML.

Analysis of the data demonstrated a "strong trend" for improved overall survival, while adverse events were consistent with the known safety profile of the drug.

Dr Xavier Thomas of the Hospital Edouard Herriot in Lyon, one of the trial's lead investigators, said: "Compared with the accepted standard therapies used in this study to treat older patients with AML, Dacogen showed a clinically relevant overall survival advantage without major differences in safety."

Janssen-Cilag markets and develops Dacogen across the world other than in North America, where its partner Eisai holds the rights.

The treatment is indicated for myelodysplastic syndromes, including refractory anaemia and chronic myelomonocytic leukaemia.