Boehringer's volasertib meets OS endpoint in AML patients

Boehringer Ingelheim GmbH (Ingelheim, Germany) said IV volasertib ( BI 6727) plus low-dose cytarabine (LDAC) met the secondary endpoint of improving median overall survival (OS) vs. LDAC alone in the Phase II portion of a Phase I/II trial to treat previously untreated acute myelogenous leukemia (8 vs. 5.2 months, p=0.047). The data came from 87 AML patients considered ineligible for intensive remission induction therapy. Data were published in Blood. In December 2012, Boehringer reported interim data from the Phase II portion showing volasertib plus LDAC non-significantly improved the primary endpoint of objective response rate (ORR) vs. LDAC alone. ...