Date: 2014-07-08
Type of information: Publication of results in a medical journal
phase: 2
Announcement: publication of results in Blood
Company: Boehringer Ingelheim (Germany)
Product: volasertib
Action
mechanism: Volasertib* is an investigational compound that inhibits enzymes called Polo-like kinases (Plks). Plk1 is the best characterized kinase of the Plk family. Inhibition of Plk1 by volasertib* ultimately results in cell death (apoptosis).By inhibiting Plk1 activity, the extremely high cell division that is characteristic of AML should be blocked, which may result in cancer regression. Volasertib* was awarded Breakthrough Therapy Designation by the FDA in 2013 and Orphan Drug Designation by the FDA and the European Commission in 2014. It is currently being investigated in combination with LDAC in a randomised, double-blind, multi-centre, controlled Phase III clinical trial for AML called POLO-AML-2.
Disease: acute myeloid leukemia (AML)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On July 8, 2014, Boehringer Ingelheim announced that results from a Phase II study, published in the American Society of Hematology journal Blood, showed patients with previously untreated acute myeloid leukemia (AML) aged 65 or older and ineligible for intensive remission induction therapy, lived longer when treated with volasertib* combined with low dose cytarabine (LDAC), a form of chemotherapy, compared to LDAC alone. The overall survival data showed that volasertib*, when used in combination with LDAC, increased the percentage of older AML patients who achieved remission. The Phase II clinical trial showed patients treated with volasertib* combined with LDAC had a median overall survival of 8 months versus 5.2 months in patients treated with LDAC alone. The response rate (complete remission or complete remission with incomplete blood count recovery) was more than doubled for patients receiving volasertib* and LDAC versus LDAC alone (31% versus 13.3%). The most common non-haematological adverse events for patients receiving the combination treatment were decreased white blood cells with fever and infections and gastrointestinal side effects. These side effects were clinically manageable and were expected given the mechanism of action of volasertib*. (Randomized, phase 2 trial comparing low-dose cytarabine with or without volasertib in AML patients not suitable for intensive induction therapy. Hartmut et al. http://dx.doi.org/10.1182/blood-2014-03-560557)
