Updated on 12 December 2012
Hope for acute myeloid leukemia (AML) patients - Phase II Boehringer Ingelheim study with volasertib shows positive signs
Singapore: A phase II interim analysis of a randomized study involving Boehringer Ingelheim's investigational haematology/oncology compound volasertib in newly diagnosed patients with acute myeloid leukemia (AML) has shown positive results.
Higher rates of objective response (primary endpoint) and an improvement in event free survival (secondary endpoint) were observed in patients treated with volasertib, a selective and potent polo-like kinase (Plk) inhibitor, in combination with low-dose cytarabine (LDAC) compared to patients treated with LDAC alone.
Secondary endpoints included event-free survival (EFS), overall survival (OS) and safety. EFS was measured from the date of randomization to the date of disease progression (treatment failure), relapse or death from any cause, which ever occurred first.
Professor Klaus Dugi, corporate senior VP, medicine, Boehringer Ingelheim, said that, "The results from this trial provide insight into the potential of volasertib combined with LDAC in patients with AML not eligible for intensive induction chemotherapy. Based on the results observed in this difficult-to-treat patient population, we are expanding our volasertib haematology clinical programme to further explore this investigational compound."
Acute leukaemias are rare diseases, with AML being the most common type of leukemia in adults. There is currently a high unmet medical need in AML, which has the lowest survival rate of all leukaemias. The goal of treatment for patients with AML is to reduce the number of blast cells in the bone marrow and return to normal blood counts.