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 low dose Cytarabine alone.
The overall survival data showed that Volasertib, when used in combination with low dose Cytarabine, increased the percentage of older AML patients who achieved remission.
The phase II clinical trial showed patients treated with Volasertib combined with low dose Cytarabine 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 low dose Cytarabine versus LDAC alone ( 31% versus 13.3% ).
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 acute myeloid leukaemia should be blocked, which may result in cancer regression.
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.
Acute myeloid leukaemia is an aggressive blood cancer mainly affecting people over age 60. It is one of the most common types of acute leukaemia in adults, accounting for approximately one third of all adult leukaemias in the Western world and with one of the lowest survival rates of all leukaemias.
In AML patients the prognosis worsens with increasing age, with a median survival of less than a year following diagnosis.
The current standard of care for younger AML patients is intensive chemotherapy. However, 40% of AML patients cannot tolerate this treatment due to their age and comorbidities and the debilitating side effects. ( Xagena )
Source: Boehringer Ingelheim, 2014