Helsinn and MEI Pharma have discontinued a phase 3 study evaluating pracinostat, in combination with azacitidine, for frontline treatment of older patients with acute myeloid leukemia (AML).
The decision to stop the study was made after an interim futility analysis by an Independent Data Monitoring Committee showed that it was unlikely to meet the primary end point of overall survival. The phase 3 study compared pracinostat, an oral histone deacetylase inhibitor, to placebo in combination with azacitidine in adult patients with newly diagnosed AML who were unfit to receive standard intensive chemotherapy due to age (≥75 years) or comorbidities.
According to the Companies, other studies evaluating pracinostat will continue at this time. Pracinostat, in combination with azacitidine, is also being evaluated in a phase 2 study in patients with high and very-high risk myelodysplastic syndromes previously untreated with hypomethylating agents.