Phase III trial of SB 393 plus Vidaza in acute myeloid leukaemia discontinued.- Helsinn + MEI Pharma

Helsinn and MEI Pharma have discontinued a Phase III trial of SB 393 (pracinostat) in combination with Vidaza (azacitidine) in patients with acute myeloid leukaemia (AML) who are unsuitable for standard intensive chemotherapy. This comes after an interim futility analysis by the independent data monitoring committee indicated that it was unlikely to meet its primary endpoint of overall survival.

The study has enrolled an estimated 500 adults with newly-diagnosed AML who are unfit to receive intensive remission induction chemotherapy due to being 75 years or older or because they have comorbidities. Patients received either pracinostat or placebo, both with azacitidine therapy. Aside from the primary OS endpoint, the study was assessing morphologic complete remission, duration of complete remission and event-free survival as secondary goals. Helsinn and MEI Pharma report that the decision was not due to any safety concerns.