Boehringer Ingelheim Posts New Phase II Data For Volasertib In AML Patients

Boehringer Ingelheim recently announced new data from its Phase II trial investigating volasertib in older patients with acute myeloid leukemia (AML).

Volasertib is an investigational drug that works to inhibit Polo-like kinase (Plk) enzyme. Plk1 is one of the most researched of the five known Plk enzymes and plays a crucial role in mitosis. Inhibiting Plk1 can lead to the extended arrest of normal cell cycle, triggering cell death. Volasertib received Breakthrough Therapy designation from the FDA in September last year.

Data from the open-label Phase II study involving 87 adult patients showed that volasertib plus low-dose cytarabine improved the response and survival rate in AML patients who were not eligible for intensive treatment. The therapy also had a clinically manageable safety profile and induced responses across all AML genetic subgroups.

“We are pleased to see the Phase II results, including the new overall survival findings, of volasertib as published in ASH’s current issue of Blood. We are continuing to research volasertib’s potential in this rare disease in the ongoing Phase III study initiated last year and look forward to sharing the results with the broader AML community,” said Berthold Greifenberg, VP of Clinical Development and Medical Affairs, Oncology, BI.

Acute myeloid leukemia is an aggressive blood cancer mostly prevalent in people over the age of 60. AML is responsible for around third of all adult leukemias in the Western world and has one of the lowest survival rates of all leukemias. Intensive chemotherapy is the current standard of care for younger AML cases, however 40 percent of affected patients find that age and related comorbidities negatively affect their chemotherapy tolerance.

Prof. Hartmut Döhner, principal investigator of the Phase II trial, member of the Department of Internal Medicine III of the University Hospital Ulm, said, “Despite being a rare disease, AML is one of the most common leukemias in adults and predominantly affects older people… These clinical trial results that evaluated volasertib in combination with a lower intensity chemotherapy are important and have informed future research for this rare disease, where new treatment options are greatly needed.”

The company published the trial data for volasertib in the American Society of Hematology journal Blood.