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Boehringer Ingelheim Presents New Phase II Data for Volasertib in Adult Patients with AML
Date:12/10/2012

9–158) days and 64 (30–125) days, respectively.1

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, whichever occurred first.  In patients treated with the combination of volasertib plus LDAC, the median EFS was approximately 5.6 months (170 days) compared with approximately 2.3 months (69 days) in patients treated with LDAC alone (hazard ratio: 0.56; 95% CI: 0.34, 0.93; p=0.0237).  Follow-up for overall survival was ongoing at the time of this analysis.1   

"The preliminary results from this trial provide insight into the potential of volasertib combined with LDAC in patients with AML not eligible for intensive induction chemotherapy," said Berthold Greifenberg, M.D., vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc.  "Based on the results observed in this difficult-to-treat patient population, we are expanding our volasertib hematology clinical program to further explore this investigational compound." 

In the volasertib plus LDAC treatment arm (n=42), grade 5 non-hematologic adverse events (AEs) were infections (5%), febrile neutropenia (5%) and respiratory/thoracic/mediastinal events (7%).  Grade 3/4 non-hematologic AEs were gastrointestinal events (19/2%), general events (14/2%), infections (38/5%), febrile neutropenia (38/7%), metabolism/nutrition events (10/5%) and respiratory/thoracic/mediastinal events (14/2%).  In the LDAC monotherapy arm (n=45), grade 5 non-hematologic AEs were infections (9%), and grade 3/4 non-hematologic AEs were gastrointestinal events (7/0%), general events (16/2%), infections (7/7%), febrile neutropenia (4/9%), metabolism/nutrition events (7/0%) and respiratory/thoracic/mediastinal events (11/2%
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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