Phase Iii Randomized Trial of Volasertib Combined with Low-Dose Cytarabine (ldac) Versus Placebo Plus Ldac in Patients Aged >= 65 Years with Previously Untreated, Acute Myeloid Leukemia (aml) Ineligible for Intensive Remission Induction Therapy

Volasertib is a potent inhibitor of Polo-like kinase that induces mitotic arrest and apoptosis in cells undergoing mitosis. In a randomized, Phase II trial in patients with previously untreated AML ineligible for intensive therapy, volasertib combined with LDAC improved remission rate (31% vs 13%; p=0.052), median event-free survival (EFS; 5.6 vs 2.3 months; p=0.021), and median overall survival (OS; 8.0 vs 5.2 months; p=0.047) compared with LDAC alone (Döhner. Blood 2014). This Phase III trial was initiated to further validate the efficacy and safety of volasertib combined with LDAC in this patient population.