Antisoma plc announced that positive final data from a phase II trial of AS1413 in patients with secondary acute myeloid leukaemia (secondary AML) were presented at the American Society of
hematology (ASH) meeting in New Orleans. Follow-up of patients has now been completed, and full results are available.
Eighty-eight patients with secondary AML received the novel DNA intercalator AS1413 together with cytarabine as first-line (remission-induction) therapy. The remission rate was 42%, with 39% of patients achieving a complete remission and 3% a complete remission with incomplete
bone marrow recovery. The median duration of remission was 9.4 months, and 30% of those who achieved remission were still alive 2 years after treatment. Clinical benefit was maintained in older patients, with patients over 60 achieving remission rates and remission durations similar to those of patients under 60. Median survival for all patients was 6.6 months. The safety profile of the regimen was manageable and acceptable, and consistent with that expected for AML remission-induction therapy
Dr Harry P. Erba, Associate Professor of
internal medicine at the University of Michigan Health System, Principal Investigator in the trial, and presenter of the data at ASH, said: "The phase II study of AS1413 in secondary AML has produced encouraging data, with a 42% remission rate and a significant fraction of durable responses in this very poor-risk population. Based on these promising findings, a large, randomised phase III trial is evaluating AS1413 in patients with secondary AML."