Spotting some red and green flags in a subset of AML patients

In the battle of the Menin inhibitors in advanced AML, it’s all too easy to forget we are currently looking at early dose escalation data in the rush to declare one company is a winner or a loser in the category.

I repeat the same thing every time this happens – the goals of any phase 1 trial are nearly always the same, namely safety, MTD, DLTs, and the establishment of the recommended phase 2 dose (RP2D).

Anything else is incidental, including initials signs of activity.

This is precisely what phase 2 trials are for based on a selected dose where responses have been observed without too many serious adverse events.

Despite this obvious caveat, people will look at results and make conclusions based on skimpy data.

Here we highlight some important subtleties, nuances, and caveats to think about as the clinical development plans move forward for both Syndax and Kura Oncology.  Of course, there are other competitors always snapping at their heels, so don’t make the obvious mistake of assuming it’s an either / or situation at play…

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