Biotech Values

[mcbio]

MEIP Reports High Response Rates in Front-line AML Study

Not clear we should be excited about this data. First, the trial is in front-line AML; presumably data would be more impressive if these were relapsed/refractory AML patients.

"We are very encouraged by these early data," said Robert D. Mass, MD, Chief Medical Officer of MEI Pharma. "The protocol-specified CR/CRi rate with Vidaza alone in this patient population is 10%, so this early observed rate of 33% is particularly noteworthy. The similarity of the high response rate seen to date in this study with those observed in our pilot study in higher risk myelodysplastic syndrome (MDS) further increases our confidence in the combination of Pracinostat and Vidaza. This combination is also being assessed in our ongoing, placebo-controlled Phase II study in front line MDS. We look forward to sharing additional data from our front line AML study at a scientific conference later this year."

Second, I've read that Vidaza alone can invoke CRs in this patient population and that's presumably what's being referenced by "protocol-specified." It reads as they are referring to a historical control here; we all know there are plenty of caveats in trying to compare data in one trial to what a control has historically produced in a given patient population. All told, I think it's really hard to tell how meaningful of a benefit the MEIP drug is adding on top of Vidaza.