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Not All CAR T-Cells Are the Same: CARTITUDE Study

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Published on February 17, 2020

Key Takeaways

  • Patients should ask about clinical trials either early or as a second line of treatment.
  • There are different types of CAR T-cells; this one has a different safety profile and construct.
  • Important tests to ask your doctor about are the bone marrow biopsy, cytogenetics, FISH testing and an initial PET scan.

Multiple myeloma expert Dr. Deepu Madduri, from the Tisch Cancer Institute at Mount Sinai, talks to Esther Schorr about patient response data from the CARTITUDE-1 Study, which uses an investigational CAR T-cell therapy JNJ-4528 that targets BCMA. 

Watch as Dr. Madduri explains that participants in this trial who received a median of five prior therapies and standard-of-care treatments were no longer working had a high response rate. 

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Transcript | Not All CAR T-Cells Are the Same: CARTITUDE Study

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.

Esther Schorr:         

This is Esther Schorr at ASH 2019 in Orlando, and I’m here with Dr. Deepu Madduri and she is an Assistant Professor of Medicine, Hematology and Medical Oncology at the Tisch Cancer Institute at Mount Sinai. Thank you for being here Dr. Madduri. 

Dr. Madduri:            

Thank you for having me.

Esther Schorr:         

I really appreciate it. So, we have a very vibrant and inquisitive myeloma audience and I know that you are going to be presenting something here at ASH about a special study that you’ve been working on, so.

Esther Schorr:              

So, what this says to me is that if perhaps this is working so well with the very sick patients that is it possible that over time this could become closer to frontline?

Dr. Madduri:                            

Yeah, that’s a very good question. Yes. So, right now since this is just the characterized safety and efficacy, so the Phase II portion of this study, which is going to actually tell us how efficacious was this, were these responses long-lasting, how long did the patients stay in progression-free survival will yet to come. We also initiated Phase II and Phase III studies where we moved this therapy up front so we don’t have to wait for the patients to be so relapsed and refractured to give such a study.

Esther Schorr:              

So, then my last question about the study would be should patients who are now dealing with multiple myeloma either newly diagnosed or if they are in one of those stages of relapse, should they be asking their specialist about the study or about this approach?

Dr. Madduri:            

Yes, I’ll be talking about one of the CAR-T studies called JNJ BCMA 4528, it’s called the CARTITUDE-1 Study, so we’re just going to be talking about this is the first time the study’s being tested in the US. This was based on the LEGEND-2 study, a first in human LEGEND-2 study from China that Janssen had acquired last year and is now being done in the U.S. So, what we found is we enrolled about 29 patients in the first Phase I-B portion of this study. The part about  the Phase I is you want to confirm safety and you also want to confirm the dose tolerated that you want to use in other studies, such as Phase II and Phase III.

So, we confirm the dose, and we know it’s .75 million CAR-T cells per kilogram of body weight. We also found that all CAR Ts are not the same and so JNJ 4528 is quite unique. It has a different safety profile; it has a different CAR construct and contains two BCMA binding antibodies compared to the others. We also saw that the CRS doesn’t happen right away. CRS stands for cytokine release syndrome so as these T cells come in and try to kill the myeloma cells you see a release of cytokines and for that patients may have fever, they may have low blood pressure.

You know, there are some other effects that you can see and what we found is this is very manageable with the therapies that are available such as tocilizumab and steroids and anakinra. But the more exciting part is all these patients are heavily pretreated. They’ve had at least a median of five prior lines of therapy. Yeah, with 18, one of the patients had 18 prior lines and we found in this really aggressive myeloma population that they had 100 percent response rate. So, every single patient responded, every single patient had a reduction in their tumor.

Esther Schorr:            

So, what this says to me is that if perhaps this is working so well with the very sick patients that is it possible that over time this could become closer to frontline? 

Dr. Madduri:                          

Yeah, that’s a very good question. Yes. So, right now since this is just the characterized safety and efficacy, so the Phase II portion of this study which is going to actually tell us how efficacious was this, were these responses long lasting, how long did the patients stay in progression-free survival will yet to come. We also initiated Phase 2 and Phase 3 studies where we moved this therapy up front so we don’t have to wait for the patients to be so relapsed and refractured to give such a study.

Esther Schorr:            

So, then my last question about the study would be should patients who are now dealing with multiple myeloma either newly diagnosed or if they are in one of those stages of relapse, should they be asking their specialist about the study or about how this approach?

Dr. Madduri:            

Yeah, right now for relapsed/refractory patients there are quite a lot of different studies. There are bispecifics. I know Celgene talked about some T-cell engager data that also looked promising. We also have the BB2121 studies, the BB2121 CAR-T studies and also the JNJ CAR-T studies. So, I actually urge all patients to look for clinical trials, either early on or at least when they start noticing that they’re relapsing the first time just so they can look at all the various options that you have. In this very heavily pretreated refractory population, we’re having trials that are showing benefit. But just imagine what would happen if they were actually referred to trials earlier and they could get on one of these studies before it got that far. 

Esther Schorr:          

So, the message is a treatment option that should always be discussed is, is there a trial out there that they ask for. Is there a particular test that myeloma patients upfront should be asking for or make sure happens so that these new treatments can be considered? 

Dr. Madduri:            

Yeah, I think they should all—you know we all do a bone marrow biopsy but it’s important to do theircytogenetics and FISH testing, so we can just characterize how high risk and intermediate risk they are, but at the same time if you’re relapsing after three or four lines you’re technically considered high risk regardless of what your bone marrow shows. But I think it’s always important to make sure you have bone marrow with cytogenetics as part of your initial diagnostic testing. Some patients like we get a baseline PET scan to see if there’s any bone involvement. As you know, myeloma affects the bone very well, so I encourage them to get an opinion with their doctor and make sure all the tests that they needed to be done are done.

And also, just see is there another clinical trial option that I could do early upfront or even just know where to go if that’s the time you need a trial. 

Esther Schorr:          

Great. Thank you so much for sharing this. It’s really breaking news for everybody and congratulations. 

Dr. Madduri:            

It’s very exciting times. 

Esther Schorr:          

Yeah, and congratulations on delivering this at ASH. And 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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