Positive results in Phase II study of BI 6727 (Boehringer) in patients with AML

Phase II results from an interim analysis of a study involving BI 6727 (volasertib), from Boehringer, in newly diagnosed patients with Acute Myeloid Leukemia (AML) shows higher rates of objective response and an improvement in event free survival in patients treated with volasertib in combination with low-dose cytarabine (LDAC), compared to patients treated with LDAC alone. Objective responses were observed in 31 percent of patients (13 of 42 patients) treated with the combination of volasertib plus LDAC compared with 13.3 percent of the patients (6 of 45 patients) treated with LDAC alone.

Based on these 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. Data were presented at the American Society of Hematology annual meeting.