Patients with AML who are treated with a combination therapy of venetoclax and azacitidine tend to experience high frontline response rates but ultimately relapse, and survival rates for R/R AML are very low.

The study presented by Dr Naval Daver explored adding magrolimab, an anti-CD47 antibody that blocks macrophages’ “don’t eat me” signal, to the combination.

The ongoing Phase II study enrolled 48 patients from a variety of AML types: newly diagnosed, R/R without previous venetoclax treatment and R/R following venetoclax treatment.

The complete response rates and CR/CRi were 64% and 76% for newly diagnosed patients including a CR rate of 64% in TP53 mutated frontline patients. CR/CRi rates were 63% in those who were R/R but had not been treated with venetoclax and 27% in those who were R/R following venetoclax treatment.

While anemia after dose 1 and 2 was a common side effect in the study participants, it was manageable, and the combination of venetoclax, azacitidine and magrolimab was found to be especially effective in newly diagnosed older/unfit patients with AML.

“The high complete response rate for newly diagnosed patients, especially high-risk patients such as those with TP53 mutations, is especially encouraging,” Daver said. “Adding magrolimab to the existing venetoclax and azacitidine combination will be evaluated in a randomized multinational Phase III study in older/unfit patients with newly diagnosed AML.”

Source: MD Anderson Cancer Center