Tag Archive for: CAR T treatment

What Is the Impact of CAR T-Cell Therapy Access Barriers on Patients?

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What Is the Impact of CAR T-Cell Therapy Access Barriers on Patients? from Patient Empowerment Network on Vimeo.

How do CAR T-cell therapy access barriers impact patients? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses factors that create CAR T-cell therapy access barriers and the impacts of FACT accreditation and the REMS program.

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Transcript:

Lisa Hatfield:

Dr. Patel, how do you perceive the impact of patient access barriers, such as geographical constraints and caregiver requirements on the widespread adoption of CAR T therapies for myeloma patients?

Dr. Krina Patel:

Yeah, so this is a huge, huge problem. I think I’m such a big CAR T fan because again, it works so well, it gives people this amazing quality of life, so once they can get it, it’s phenomenal, and people want it again, if they can get it again down the road. But you have to get there, and so the biggest barriers, I will say is insurance coverage, making sure your insurance, now most people who have insurance it will cover, but some people with Medicare, if they don’t have a secondary, that 20 percent that you have to cover is insane. I don’t think most people would not be able to do that. So that’s number one.

Number two is location. And again, if you can’t come somewhere, there’s about 200 centers in the U.S. that are FACT-accredited, and you have to be…it’s an acronym basically for anyone that does cell therapy, and you have to be accredited to be able to give CAR T, so unlike other therapies like bispecifics that are not under that jurisdiction, for CAR T, you have to have that designation, so there are quite a few centers around the country that have that.

But again, access to myeloma CAR Ts is still limited to a certain degree, and so finding a place that’s nearby and having a caregiver, these are all really, really important, but we’re hoping that in the future with better CAR Ts, we won’t have to worry about staying in the vicinity for 30 days. We’re actually trying to push already to say that a lot of our patients, the majority do really well, that after two weeks, they should be able to go back home, and we can work with their local oncologist, their local doctors to make sure everything’s okay.

I think the original CAR Ts were in lymphoma and there were some pretty significant side effects we saw, so even that can’t drive for eight weeks and all these other things that we all have to do, all our patients have to do now came from that, even though most of our patients don’t get neurotoxicity, right, in myeloma, we don’t see those things. So again, we’re trying to find novel ways to push back and say to the FDA, do we really need these patients to stay here this long when our data looks so much different and better than it does for other diseases?

So I think that’s part of it as well. Through some of our newer trials, we’re trying to see if we can decrease those recommendations that once they get approved, it won’t be a part of the REMS program and all these things that. If once it becomes part of the REMS program, we have to do it and it’s hard to reverse that. But I know a lot of the companies are, and myeloma groups are trying to get together to decrease some of that burden, because it might be a little bit too much for the majority of our patients where they don’t need it medically and I know it would help them get access to the drugs, but coming back to the novel CAR Ts, there are ways to make the CAR T in less than 48 hours now that people are testing, and if we can do that, that can really decrease your time of even having to come get your cells collected, then go back home for bridging therapy, then come back for the actual CAR T treatment.

And if we can give it to you faster and we can decrease that toxicity, then hopefully again, it could be two weeks and then we get you back home. So I think that’s the ultimate goal. I just don’t know when that will happen.

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How is Treatment Fitness Determined in Multiple Myeloma?

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How is Treatment Fitness Determined in Multiple Myeloma? from Patient Empowerment Network on Vimeo.

How is treatment suitability assessed in myeloma care? Dr. Sikander Ailawadhi, an expert from Mayo Clinic, elaborates on the factors taken into account when determining the appropriateness of treatment for myeloma patients.

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Transcript:

Lisa Hatfield:

Oh, great. Okay. Again, important to see a myeloma specialist to tease out all this information. Thank you. All right. This patient is asking, “I’m 81 and living with comorbidities. The myeloma was diagnosed after bone marrow test. How is treatment fitness determined?” And also a question about that is if you’re given an ECOG status of something you don’t like it, can that be improved after you’ve had treatment?

Dr. Sikander Ailawadhi:

Absolutely.

Lisa Hatfield:

Maybe be eligible for a trial or something.

Dr. Sikander Ailawadhi:

Correct. Correct. That is so important. When this patient mentioned that they’re 81-year-old and they’re living with comorbidities, I think, so when I’m talking to a patient who’s new to me, it’s very important for me to try to tease out what was their performance status or their fitness status prior to myeloma. Because my goal is to try to get them as close to that as possible.

Now if this patient is saying that they were already quite frail before the diagnosis of myeloma and myeloma is added to the frailty, then it becomes a little tricky because we’re starting in a difficult spot. We do determine fitness by asking questions, simple questions like, what can a patient do at baseline? Can they do grocery store or grocery shopping by themselves? Can they walk around the block? Do they get short of breath? Et cetera.

And frankly, there are 81-year-olds who are playing golf every day and are fitter than me. So I’m just saying that age by itself is not the criteria. And, Lisa, like you rightly mentioned, if there are fitness issues coming from the disease itself, then that’s the time that we actually have to work with the treatment, get the treatment started, and then assess the fitness a couple of months later, a couple of cycles later. Because the treatment may have worked and may have improved the fitness quite a bit.

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Navigating Myeloma CAR T-Cell Relapse: Patient Next Steps

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Navigating Myeloma CAR T-Cell Relapse: Patient Next Steps from Patient Empowerment Network on Vimeo.

What are next steps for myeloma CAR T-cell patients who experience relapse? Expert Dr. Sikander Ailawadhi from Mayo Clinic explains options for relapsed myeloma patients and shares patient advice.

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See More from START HERE Myeloma

Related Programs:

What Factors Shape Myeloma Treatment Options After Relapse?

 Myeloma Treatment Timing: Prior Therapies and FDA Approval Rationale

 How is Treatment Fitness Determined in Multiple Myeloma?

Transcript:

Lisa Hatfield:

Okay. So what would be the next steps, Dr. Ailawadhi, for a patient who’s had CAR T and reaches a relapse state or is relapsed?

Dr. Sikander Ailawadhi:

Yep. This is something, unfortunately is the truth of the matter in myeloma at least that we are, we don’t seek cures. We have had some long remissions. I have, for example, patients who are now reaching three, three-and-a-half years of remission on CAR T treatment who received it on clinical trials even before they got FDA-approved.

But, unfortunately, the disease does come back. So what happens is, we are seeing data that the novel, other novel immunotherapies like bispecific antibodies, even the ones who go after the same target as CAR T, BCMA targeting bispecifics, they do have some response rates, good response rates in post CAR T setting. So the bispecific antibodies by themselves may give us 60 to 65 percent response, but in the post CAR T setting, that response might go down to 40, 45 percent. So less responses, but still possible.

There are also bispecific antibodies. There is one available, which is not against BCMA, it is against GPRC5D. That’s a bispecific called talquetamab-tgvs (Talvey). So a novel target. There is…there are of course a lot of clinical trials. There are some clinical trials that are even looking at CAR T post-CAR T. So different kind of a CAR T. Those clinical trials are going out. So what I would suggest is that if your disease progresses after CAR T-cell treatment, you should very strongly consider getting to a specialist myeloma center and get an opinion like you mentioned, Lisa.

That is so important because the choice of treatment is extremely important at that time. And we are trying our best to sequence all the options we have, in a way, actually one of my patients mentioned, one of these days, ”Hey, does that mean that I’m basically buying time till something new and exciting comes along?” And I said, “In a way that is true. That we are trying to stretch all our treatments and get to the point that something new and promising just like CAR T comes, and hopefully we get longer benefits again.”

Lisa Hatfield:

So when you say there’s a possibility of CAR T and then a post-CAR T maybe a second CAR T. Would that be a different target then?

Dr. Sikander Ailawadhi:

So there could be a different target. I have, in fact, I saw a patient who had received one CAR T in a clinical trial and then they were subsequently able to receive a CAR T standard of care, which had been FDA-approved. So they used different CAR Ts, but one was in clinical trials and one was standard of care.

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