Boehringer targets AML
pharmafile | March 1, 2013 | News story | Research and Development, Sales and Marketing | AML, Boehringer
Boehringer Ingelheim is to begin a pivotal trial of its investigative treatment volasertib in patients with acute myeloid leukaemia (AML).
The Phase III study POLO-AML-2, announced on Rare Disease Day, will evaluate the polo-like kinase (Plk) inhibitor with chemotherapy in patients who are ineligible for intensive therapy.
AML patients suffer the rapid spread of abnormal blood precursor cells in the bone marrow which interfere with the production of normal blood cells.
The nascent class of investigational drugs to which volasertib belongs is designed to inhibit the activity of Plk – including Plk1, an enzyme that regulates cell division.
POLO-AML-2’s primary endpoint is objective response to the combination treatment compared to chemotherapy alone, with a secondary endpoint of overall survival.
Phase II results were encouraging, with higher rates of objective response and an improvement in event-free survival in patients receiving the combination rather than just chemotherapy.
“The initiation of the POLO-AML-2 trial is a significant milestone as therapeutic options are limited in AML patients ineligible for intensive therapy,” said Professor Klaus Dugi, Boehringer’s corporate senior vice president, medicine.
The average age of newly-diagnosed patients is 65 years and the disease prognosis worsens with increasing age.
Median survival is six months or less for older patients who cannot have intensive remission induction therapy – which is often used in younger patients – because of the high doses of chemotherapy involved.
AML accounts for around a third of all adult leukaemias but is still a rare cancer of the bone marrow and the blood, and has one of the lowest survival rates. There are five to eight cases per 100,000 people of AML in Europe each year, putting it into the rare disease bracket.
Meanwhile Boehringer is also conducting late-stage trials of nintedanib, a small molecule tyrosine kinase inhibitor (TKI), in the fatal respiratory disease idiopathic pulmonary fibrosis (IPF).
Nintedanib targets growth factor receptors which are potentially involved in the development of IPF, and the pivotal INPULSIS-1 and INPULSIS-2 Phase III trials are ongoing.
The Phase II TOMORROW trial demonstrated a positive trend in reducing lung function decline in IPF patients treated with 150 mg of nintedanib twice daily compared to placebo.
The product has already been given orphan-drug designation by the FDA.
Adam Hill
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