EHA 2022 | Ongoing trials in AML and HR-MDS: ENHANCE, ENHANCE-2 and ENHANCE-3

To start with, there are actually three different Phase III studies with magrolimab at this time. One is in high-risk MDS, including both TP53 mutated and TP53 wild-type. That study is going to look at azacitidine-magrolimab versus azacitidine-placebo in all higher-risk MDS patients. The second study is in AML, that’s called ENHANCE-2 looking at azacitidine-magrolimab, so the doublet, versus investigator choice of azacitidine-venetoclax or 3 + 7 intensive chemo, but only in TP53 mutated, so it’s a mutation-specific study.

And then the third study called ENHANCE-3 is the study of azacitidine-venetoclax-magrolimab, so the triplet versus azacitidine-venetoclax-placebo, and that’s in all comers; TP53 wild-type, TP53 mutated, but it’s in the exact population of patients where azacitidine-venetoclax is approved, meaning either 75 years of age or older or patients who are deemed unfit because of the clearly documented comorbidity, creatinine clearance, cardiac issues, pulmonary issues, hepatic issues. So the goal there is to see if this triple drug, basically adding magrolimab to azacitidine-venetoclax can improve remission rates, CR rates specifically, and most importantly, overall survival in time. And if that’s true, then we could have a new standard of care for that triple combination.