Date: 2013-02-28
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Boehringer Ingelheim (Germany)
Product: volasertib
Action
mechanism: Volasertib is an inhibitor of Plk (an enzyme that regulates cell division) It is currently being evaluated in clinical trials for AML and is one of several late-stage compounds that Boehringer Ingelheim is currently evaluating in clinical trials for cancer.
Disease: acute myeloid leukemia (AML)
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The Phase III study (NCT01721876) has been designed to assess the efficacy and safety of volasertib in combination with LDAC compared with LDAC alone. The trial POLO-AML-2 will enroll eligible patients aged 65 or older with previously untreated AML who are ineligible for intensive remission induction therapy.
Latest
news: * On February 28, 2013, Boehringer Ingelheim has announced the enrollment in a Phase III study (POLO-AML-2) investigating volasertib, a selective and potent polo-like kinase (Plk) inhibitor, in combination with chemotherapy, in patients with acute myeloid leukaemia (AML) ineligible for intensive therapy. The primary endpoint of POLO-AML-2 is objective response to the combination treatment compared to the chemotherapy alone. The main secondary endpoint of POLO-AML-2 is overall survival. Boehringer Ingelheim intends to begin recruitment of a Phase III study (NCT01721876) to assess the efficacy and safety of volasertib in combination with LDAC compared with LDAC alone in early 2013. The planned Phase III trial, POLO-AML-2, will enroll eligible patients aged 65 or older with previously untreated AML who are ineligible for intensive remission induction therapy.
* On December 10, 2012, Boehringer Ingelheim has announced that new positive Phase II results from an interim analysis of the randomised Phase I/II study involving the company’s investigational haematology/oncology compound volasertib in newly diagnosed patients with acute myeloid leukemia (AML) considered ineligible for intensive remission induction therapy were presented at the 54th American Society of Hematology (ASH) annual meeting in Atlanta, USA.
In this study, higher rates of objective response (primary endpoint) and an improvement in event free survival (secondary endpoint) were observed in patients treated with volasertib*, a selective and potent polo-like kinase (Plk) inhibitor, in combination with low-dose cytarabine (LDAC) compared to patients treated with LDAC alone.
The open-label study enrolled 87 adult patients randomly assigned to receive either volasertib* in combination with LDAC (n=42) or LDAC alone (n=45). The primary endpoint was objective response (complete remission [CR] or CR with incomplete blood count recovery [CRi]). Objective responses were observed in 31 percent of patients (13 of 42 patients) treated with the combination of volasertib* plus LDAC compared with 13.3 percent of the patients (6 of 45 patients) treated with LDAC alone (odds ratio: 2.91; p = 0.0523). The median (range) time to remission was 71 (29–158) days and 64 (30–125) days, respectively. EFS was measured from the date of randomisation 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 5.6 months compared with 2.3 months in patients treated with LDAC alone (hazard ratio: 0.56; 95% CI: 0.34, .93; p=0.0237). An increased frequency of higher grade adverse events (AEs) (CTCAE grade 3-5) was observed in patients treated with volasertib plus LDAC compared to LDAC alone (95.2 vs. 68.9%). Focusing on the AEs of higher severity, the difference was most prominent for blood and lymphatic system disorders (81% vs. 44.4 %), gastrointestinal disorders (21.4% vs. 6.7%), and infections (47.6% vs. 22.2%). This was expected given the mechanism of action of volasertib.
