Boehringer Ingelheim Corporation to Initiate Phase III Study in Leukemia With its Compound Volasertib* Based on Positive Phase II Results  
12/10/2012 9:43:23 AM

INGELHEIM, Germany--(BUSINESS WIRE) -- New positive Phase II results from an interim analysis of the randomised Phase I/II study involving the company’s investigational haematology/oncology compound volasertib* in newly diagnosed patients with acute myeloid leukemia (AML) considered ineligible for intensive remission induction therapy were presented at the 54th American Society of Hematology (ASH) annual meeting in Atlanta, USA. In this study, 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.1 Based on these positive results Boehringer Ingelheim announced the initiation of a Phase III study of volasertib* in combination with LDAC (POLO-AML-2 (1230.14)), which is expected to start in early 2013.