Blinatumomab & Ponatinib for ALL

Today, we're going to talk about some big old news, maybe, and that is this publication this week of panetinib blenitumab for fairly positive adult patients.

acute lymphoblastic leukemia, or ALL.

Now I say this is new, old, because it's a new study, just published, and it's old because I think a lot of people have been doing blunitumab and ponatinib for fully positive ALL If you look at our favorite guidelines, the preferred treatment, the right answer on the test based on the guidelines is clinical trial.

Because of a lack of randomized controlled clinical trials in this space, which is an issue for another podcast maybe, or systemic treatment plus tyrosine kinase inhibitor, and that's sort of differentiated by age.

So if you're older, like above the age of 65 or unfit, that would be TKI plus Blenna maybe, or TKI and vincristine and prednisone, or TKI and just steroids.

For those that are fit, it's TKI plus Blen or TKI plus HyperCVAD is what is recommended in our favorite guidelines.

So this is a randomized controlled trial of ponatinib and Blenatumab compared to imatinib chemotherapy for adult Philly ALL.

So this is an investigator-initiated study.

This is from the, I think it's an Italian group, the GIMEMA.

It's a European group.

It's sponsored by the Italian Association of some words in Italian I don't understand after that.

And they do talk about how imatinib is the most readily available TKI in this space.

They did do 600, 800 of imatinib.

They did a higher dose.

But, you know, most people are not using imatinib, the first-generation B-cerebral inhibitor for filipositive ALM.

The guidelines recommend only using imatinib if you don't tolerate... panatinib, dasatinib, et cetera, these more potent agents.

This is a relatively small study, so it's fewer than 250 patients, and they sort of, there's a tell here, they know that their control arm is maybe not the most appropriate because they are randomized two to one.

So if you're a patient being pitched this study, there's a two-thirds odds you're going to get the ponatinib ARB and just a one-third you're going to get imatinib plus chemo.

They also do, I think, inherently acknowledge the equipoise and people are going to want lenitumab ponatinib in that they do have very predefined crossover criteria.

So the folks, this is not you know, a lot of the industry sponsored studies where they don't allow crossover here.

No, these patients are crossing over to Blenponatinib at appropriate time points.

The primary endpoint here, back up a little bit.

So there, well, we'll get to that.

We'll get to the history here.

So primary endpoint is event-free survival.