Boehringer Ingelheim announces new data from volasertib Phase I/II leukemia study

Boehringer Ingelheim today announced that new data evaluating volasertib, an investigational polo-like kinase (Plk) inhibitor, will be presented at the 54^th American Society of Hematology (ASH) annual meeting taking place December 8-11 in Atlanta, Ga.  Data include results from the Phase II portion of a Phase I/II study evaluating volasertib administered in addition to low-dose cytarabine (LDAC) compared to LDAC monotherapy in newly diagnosed acute myeloid leukemia (AML) patients ineligible for intensive treatment.  Additionally, volasertib pre-clinical data in refractory pediatric leukemia cells will be presented.

"Boehringer Ingelheim is looking forward to presenting the results for volasertib, a late-stage developmental compound in our growing oncology pipeline," said Berthold Greifenberg, M.D., vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc.  "The results add to a growing body of knowledge for volasertib and merit further investigation in this difficult-to-treat patient population with acute myeloid leukemia (AML)."

Abstract details for each study are provided below:

Presentations of Boehringer Ingelheim Investigational Oncology Compound Volasertib at ASH 2012 Annual Meeting

The Phase II results -- from the Phase I/II study that will be presented at ASH -- support the initiation of the Phase III POLO-AML-2 study (NCT01721876), which is designed to assess the efficacy and safety of volasertib in combination with LDAC compared to LDAC.  The planned Phase III trial will enroll eligible patients aged 65 or older with previously untreated AML, who are ineligible for intensive remission induction therapy.