Dr. Talati on the Rationale for Venetoclax in AML

Chetasi Talati, MD, hematologic oncology, Moffitt Cancer Center, assistant member, Moffitt Cancer Center in the Department of Malignant Hematology, discusses the rationale for investigating venetoclax (Venclexta) in acute myeloid leukemia (AML).

Venetoclax has had significant impact in hematologic malignancies such as chronic lymphocytic leukemia and multiple myeloma, says Talati.

AML is associated with a high level of BCL-2 expression, explains Talati. Therefore, venetoclax could potentially induce anti-leukemic effects in this patient population.

Initial data showed that, as monotherapy, venetoclax induced modest response rates in the relapsed/refractory setting. However, in November 2018, the FDA granted an accelerated approval to venetoclax in combination with the hypomethylating agent azacitidine or decitabine or low-dose cytarabine for the treatment of patients with newly diagnosed AML who are over the age of 75, or who are ineligible for intensive induction chemotherapy due to comorbidities. Data from the phase 3 VIALE-A trial showed that the combination of venetoclax and azacitidine led to a 34% reduction in the risk of death versus azacitidine alone in this patient population. The results from the trial, which were presented during the 2020 European Hematology Association Congress, are practice changing, concludes Talati.