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Boehringer Ingelheim's investigational volasertib receives FDA Breakthrough Therapy designation
Date:9/17/2013

is intensive chemotherapy to induce disease remission, followed by consolidation/maintenance chemotherapy. However, many patients over 65 years of age – whose prognosis is typically poor7 – are ineligible for this approach, which involves large doses of chemotherapy over short periods of time,6 and therefore have even fewer treatment options. Volasertib* is currently being investigated in this specific patient population.8

Results from a Phase II study, in newly diagnosed patients with AML considered ineligible for intensive remission induction therapy, demonstrated higher rates of objective response and an improvement in event-free survival in patients receiving volasertib in combination with low-dose cytarabine (LDAC) compared to patients receiving LDAC alone.9 The results were presented at the 54th American Society of Hematology (ASH) annual in December 2012.9

These results led to the initiation in January 2013 of a Phase III trial, POLO-AML-2 (Clinical Trial Identifier: NCT01721876).8 This trial is designed to assess the efficacy and safety of volasertib in combination with LDAC, compared to placebo in combination with LDAC, in patients aged 65 or older with previously untreated AML, ineligible for intensive remission induction therapy.8 The trial is currently enrolling eligible patients.8 For more information please visit ClinicalTrials.gov.8

About Volasertib
Volasertib, an investigational inhibitor of polo-like kinase (Plk), is one of several late-stage compounds that Boehringer Ingelheim is currently evaluating in clinical trials for various solid tumors and hematological cancers. Boehringer Ingelheim is one of the first companies
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SOURCE Boehringer Ingelheim
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