An experimental therapy for a subtype of leukaemia awarded 'breakthrough' status on both sides of the Atlantic has continued to impress by hitting targets in a Phase II clinical trial.

Boehringer Ingelheim's polo-like kinase inhibitor Volasertib was shown to improve overall survival in older patients with acute myeloid leukaemia (AML).

In the Phase II trial, those treated with a combination of BI's drug and low dose cytarabine (LDAC) had a median overall survival of 8 months compared to 5.2 months in patients given the chemotherapy alone.

Also of note, the response rate (complete remission or complete remission with incomplete blood count recovery) was more than doubled for those taking the combination versus LDAC alone (31% versus 13.3%, respectively).

Safety issues 'expected' and 'manageable'

On the safety side, the most common non-haematological adverse events for patients taking Volasertib/LDAC were decreased white blood cells with fever and infections and gastrointestinal side effects, but these were expected and deemed clinically manageable, the firm said.

The need for new treatment options in AML is very high, says Professor Klaus Dugi, BI's Chief Medical Officer. The average age of newly-diagnosed patients is 65, but this age group is often unable to tolerate the most common treatment approach for the condition - intensive remission induction therapy - highlighting the current unmet need.

The firm will be hoping that Volasertib will help fill this gap, and is "optimistic that the drug will further demonstrate its potential benefit in this rare disease in the ongoing Phase III study," according to Prof Dugi.