Science

Disease Background: AML is the most common type of acute leukemia in adults. It is characterized by a rapid proliferation of immature white cells in the bone marrow. This results in accumulation of leukemic cells and subsequent interference with normal blood cell production, leading to complications including anemia, infections and bleeding. AML is diagnosed in over 20,000 patients in the US annually and is rapidly lethal if left untreated. Successful treatment typically requires intensive chemotherapy with or without bone marrow transplantation; however, relapse and resistance are common. Consequently, there is an urgent need for effective therapies in patients who are relapsed/refractory after initial therapy, particularly those who are ineligible for intensive therapy or bone marrow transplant due to age or co-morbidities. In recognition of the unmet needs for this patient population, the US FDA has granted bemcentinib Orphan Drug Designation as well as Fast Track designation in AML.

Bemcentinib Data in AML Patients BerGenBio has completed a Phase 2 study (BGBC003) testing bemcentinib as a monotherapy and in combination with chemotherapy in AML. In the BGBC0035 study the combination of bemcentinib with the chemotherapy LDAC showed particularly promising results in relapsed/relapsed AML. A clinical manuscript describing the results in more detail is in press and will be made available once published.