Meet The Professors: Acute Myeloid Leukemia Edition, 2017 (Video Program) - Video 6Potential incorporation of midostaurin into the treatment algorithm
3:06 minutes.
TRANSCRIPTION:
DR LOVE: I’m going to ask Jorge the same question, but I’m going to ask you right now, which is, we wake up one morning, check our phones and find that midostaurin is approved. And, of course, the details of that will be important. But in general, if it were approved, how would you like to use midostaurin, in what situations? DR STONE: Right now, I would only argue for using it exactly in this same situation for this clinical trial, that people had to be between 18 and 60. Obviously, fit enough for chemotherapy without major end organ problems. And then I would use it in those people who were FLT3-positive. DR CORTES: Yes, I mean, it’s likely that it’ll be approved. It’s likely that it’ll be approved in this patient population. But I would like to use it in older patients. I think it is likely to benefit the patients. I mean, we don’t have a randomized trial in older patients, but I think it is likely to benefit these older patients. We did a pilot study of midostaurin combined with azacitidine. It combines well in terms of safety issues. And the response rates and the durability of response were attractive, being a single-arm study. I think you cannot make too much of a definitive statement, but I was satisfied with what we get. So I think it is likely that you would get some additional benefit over azacitidine alone or over midostaurin alone as well. So I bet you that you’ll start seeing more of these studies coming out, these randomized studies. But I would like to use it in older patients as well. DR LOVE: So if you could, you would actually use it right now? Agree or disagree, Rich? I’m talking about in older patients. DR STONE: I agree. Yes. I mean, I think it is totally reasonable. The data for doing it in older patients is not as strong, but it’s reasonable. DR COLE: So the way that the trial was designed, you obviously had the FLT3 status before they were induced. So for those of us who are waiting 2, sometimes 4 weeks to get that information back, can you weave it in when they’ve already had their induction? Maybe they’re 2 to 3 weeks in and their counts are super low. Is it smart to put that on the table if it’s approved and out there, or do you bring it into consolidation? DR STONE: The good news is, I think by the time it’s approved, there will be a test that you will get back within a week. And so in the clinical trial, the placebo arm of midostaurin didn’t start until day 8. So you’ll have 8 days to — DR FEINSTEIN: That was my question, whether or not it potentiates the idarubicin and cytarabine. And that’s why it wasn’t given at the same time. DR STONE: In this trial, it was not given together. DR COLE: It’s on day 8. DR FEINSTEIN: So, that’s actually more practical DR STONE: And there’s a reason for that. Actually, number 1, there was a preceding Phase I or II trial where we combined it either after, like we ended up using, or together. It seemed like giving it afterward was a better idea, plus there’s preclinical data from Don Small at Hopkins that suggests that if you give an FLT3 inhibitor before you give chemo, you kick the cells out of cell cycle because they stop proliferating. And then the chemotherapy doesn’t work as well. |