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Boehringer takes leukaemia drug volasertib into phase III

Shows positive results in a difficult-to-treat patient population

Boehringer Ingelheim headquarters 

Boehringer Ingelheim will start phase III testing of its acute myeloid leukaemia (AML) candidate volasertib early in 2013 after encouraging results in mid-stage testing.

Phase II results from an ongoing study of volasertib in newly-diagnosed AML patients showed that the drug increased objective response rates and event-free survival (EFS) when added to a standard regimen of low-dose cytarabine (LDAC).

This is the second piece of good news from Boehringer's oncology programme in recent months after the company filed for approval of lung cancer candidate afatinib in September. The pharma company only started a major push into cancer R&D in 2006.

Volasertib is an inhibitor of polo-like kinase (Plk), an emerging target for cancer therapy that is overexpressed in a range of malignancies. One form of the enzyme - Plk1 - is particularly associated with cancer progression and may have a role in oncogenesis through the regulation of tumour suppressors such as p53 and BRCA2.

Phase II data from the phase I/II study of volasertib were presented at the American Society of Hematology (ASH) meeting this week and showed that around 19 per cent of patients on volasertib plus LDAC achieved an objective response, compared to around 7 per cent of those treated with LDAC alone.

EFS was also improved to 5.6 months with volasertib versus 2.3 months in the control group, and there was also a non-significant trend towards an increase in overall survival, at 8 months and 5.2 months, respectively. On the downside, volasertib was associated with an increase in adverse reactions, particularly gastrointestinal, metabolic and respiratory symptoms.

"Based on the results observed in this difficult-to-treat patient population, we are expanding our volasertib haematology clinical programme to further explore this investigational compound," commented Prof Klaus Dugi, corporate senior vice president, medicine, at Boehringer.

The phase II POLO-AML-2 trial will recruit 660 previously-untreated AML patients aged 65 and older who are ineligible for high-intensity therapy who will be treated with either LDAC alone or LDAC plus volasertib.

AML is particularly prevalent in the elderly and is the most common form of leukaemia in adults, with the lowest survival rate. While the most common treatment is intensive treatment with cytarabine to try to reduce the number of malignant cells in circulation, around 50 per cent of all patients are unable to tolerate this therapy.

Meanwhile, other companies developing Plk inhibitors include Onconova Therapeutics/SymBio Pharmaceuticals, whose candidate rigosertib is in early-stage clinical testing, as well as Tekmira's with TKM-PLK1 and Cyclacel.

11th December 2012

From: Research



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