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Are Newly Approved AML Drugs Changing Outcomes?

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Published on February 5, 2020

Key Takeaways

  • Recently FDA-approved AML drugs are returning results 75 to 80 percent bone marrow remission, historically standard care returned rates of 25 to 30 percent.
  • There is an increasing gap between the AML community and new research. It is increasingly important that an AML specialist consults on a patient’s case as new treatments could be curative.

Acute myeloid leukemia expert Dr. Naval Daver, from The University of Texas MD Anderson Cancer Center, talks with Patient Power co-founder Andrew Schorr about the recent FDA approvals for AML and what it means for patients, as the last two to three years have shown dramatic progress in treatment with eight approved drugs. Watch as Dr. Daver also explains how combination therapies are delivering better outcomes for AML patients.

This program is sponsored by Celgene Corporation. This organization has no editorial control. It is produced solely by Patient Power.

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Transcript | Are Newly Approved AML Drugs Changing Outcomes?

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Andrew Schorr:         

Hello, and welcome to Patient Power. I’m Andrew Schorr. We are on location, actually, in Orlando where 25,000 blood experts gather each year from around the world—not always in Orlando, sometimes in my home city, San Diego. That’s a lot closer.

At any rate, they’re here this year. And we’re with a leading expert who’s from Houston, MD Anderson, our friend Dr. Naval Daver. So, AML can be treated but then it relapses. Do you have more tools now for when AML relapses? 

Dr. Daver:                  

Yeah. Thanks, Andrew. I think that’s a very, very tough condition. And I think there are two kind of parts to this answer. So, one is our big focus at MD Anderson, but across large academic centers running trials in the U.S. and Europe, is to try to minimize relapse because what we have seen with both AML and ALL is that your first shot is really your best shot.           

And for CML, for example, that may not be as true. We can actually recover—or “salvage” is the word we use—a lot of patients who fail. But AML/ALL, we’re really trying to optimize double, triple regimens in a safe way to minimize relapse, and I think we’re getting better.

But in spite of that, today in 2019/20, in the next five to 10 years, I still think we will be seeing a large number of relapses. And for those patients what really could give them the best chance of still having a potential curative option is to find a targetable mutation. So, now we have good drugs that target particular gene mutations that are known to occur in AML. And at relapse, these could be targeted. The common ones are mutations that are called FLT3, IDH1, IDH2.

And I think it is now critical and behooves the oncologist to check for those, because there are drugs approved for all three of these targetable mutations—oral drugs, very well-tolerated, response rates are about two times higher than you would get with chemo with much less side effect and improvement in survival.

So, I think that’s the first thing we think of if we see a relapsed AML is, “Could I find one of these three gene mutation targets that could give me a targeted therapy approach, either a single agent or a combination?” And then we would actually still have a shot of trying to cure that patient.

If there is no targetable mutation, it’s a tougher situation. We do have trials now looking at different immunotherapy combinations—drugs that enhance your body’s own immune system in different ways to fight against the cancer, because cancer is smart and shuts down your immune system. But we’re learning ways where we can reactivate the immune system to fight back against cancer and some of these things, such as what we call “immune checkpoint inhibiters” or “antibody therapies,” are showing good activity.

So, those would be the ones that I would consider. Many of these are in clinical trials showing good activity but it may be one or two years, or three years even, before they go through the regulatory pathway.

So, I think for relapsed AML, really, I think it’s critical that, just like frontline but maybe even more critical, that they get a expert opinion, molecular evaluation, and look for the best clinical trial options by being in contact with their local expert academic center or KOL expert opinion leader in that arena, because there may be things out there coming that are effective.

Andrew Schorr:         

One thing about immunotherapy—so some people have seen tv commercials for lung cancer and others where there’s medicine that’s used that activates your immune system to recognize the cancer and fight it. So, that’s the kind of approach you’re talking about, maybe in combination with other drugs, to turn on the immune system that didn’t recognize the cancer the first time?

Dr. Daver:                  

Yes, exactly. It’s those same drugs, actually, that have been approved in lung cancer, melanoma, bladder—these are called “immune checkpoint inhibitors.” Basically, what they do is they shut down the breaks on your T cells, which the cancer is using to make the T cells not work. And by shutting down the breaks, they allow your T cells to be unleashed and be functional and kill the cancer.

So, it’s those same drugs now. As a single agent, they don’t seem to be as effective in leukemia, but in combination with certain standard AML drugs—drugs that we call azacitidine (Vidaza), decitabine (Dacogen)-—when we combine them, they seem to be effective.

The other important thing we’re learning is that the same checkpoint pathways that are different checkpoint markers may not be the ones that work in solid tumors in leukemia. So, for solid tumors they have the drugs that people see in commercials. These are PD-1 or PDL-1, things like that. And for leukemia, we have found unique checkpoint—TIM-3, CD47—that now seem to be working very, very well, specific for AML.

So, for each disease, there’s different ways the immune system is being shut down by cancer, and if we find the right way, which we’re now starting to find, we can get much better results.

Andrew Schorr:         

So, we have to find the way to amp up the immune system and for that disease.

Dr. Daver:                  

For that cancer. Yes, exactly.

Andrew Schorr:         

So, for people who have relapsed AML, do you feel there’s hope now?

Dr. Daver:                  

I think there’s hope. I’ll be honest, it is a very difficult condition still. But compared to five or eight years ago when we did not have any of the three targeted therapies—the FLT3, IDH1, IDH2 target therapies—which makes about 40 percent to 50 percent of all patients or we did not have any of the immunotherapies, I think it was really dismal.

We would have maybe 5 percent to 10 percent at best patients who had a chance of two/three year-plus long-term survival. Today, I think we’re better—could be up to 30 percent or 40 percent depending on the type of patient.

But, again, I think this is a group where one must evaluate all options and make sure that they try to access some of these new trials that are very, very effective.

Andrew Schorr:         

Okay. So, for you or a loved one, with this moving target of treatment now for relapsed AML, ask about clinical trials. Always ask about clinical trials. It could give you access to tomorrow’s medicine today.

In Orlando with Dr. Naval Daver from MD Anderson, I’m Andrew Schorr. Remember, knowledge can be the best medicine of all.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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