Vosaroxin Fails in Phase 3 AML Trials in the Elderly

(SNSS)

Sunesis Pharmaceuticals announced the failure of a phase 3 study Monday morning. The company's experimental drug vosaroxin did not extend survival of elderly patients with advanced acute myeloid leukemia compared to a placebo.

In the phase 3 study of 711 elderly AML patients, treatment with vosaroxin reduced the risk of death by only 13% compared to a placebo. The survival trend was not statistically significant, failing the primary endpoint of the study. At the median, vosaroxin patients lived 7.5 months compared to 6.1 months for placebo patients.

Sunesis performed another analysis of the study excluding AML patients who later underwent a stem cell transplant. In this subgroup analysis, vosaroxin reduced the risk of death by 19% compared to placebo, which was statistically significant. At the median, the survival benefit was 6.7 months for vosaroxin patients compared to 5.3 months for placebo patients.

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