CAR T-Cell Therapy Patient Eligibility | What Patients Should Know

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CAR T-Cell Therapy Patient Eligibility | What Patients Should Know from Patient Empowerment Network on Vimeo.

What should CAR T-cell therapy patients know about patient eligibility? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses transplant eligibility factors, why the factors are examined, and proactive advice for patients.

[ACT[IVATION TIP

“…tell your doctor, “I’m interested in CAR T. I want to go talk to a CAR T center.” And that’s where they can tell you if something is possible or not.”

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 CAR T-Cell Therapy Follow-Up Monitoring | What Patients Can Expect

CAR T-Cell Therapy Follow-Up Monitoring | What Patients Can Expect

Transcript:

Lisa Hatfield:

Dr. Patel, what challenges exist in navigating the complexities of patient eligibility criteria for CAR T therapy, particularly in the context of comorbidities and prior treatments and how can these challenges be navigated more effectively?

Dr. Krina Patel:

Yeah, I think it’s, people compare it to stem cell transplant all the time, and that’s my biggest activation tip. Transplant eligibility is not the same as CAR T eligibility. CAR T eligibility is much easier. So the absolute contraindication I would say for CAR T, is probably my patients with dementia, right? Because some of the chemo that we give prior to the CAR T can worsen that. And things like ICANS, this neurotoxicity can worsen some of those symptoms and we don’t want that.

That’s where I would use a bispecific instead where we’ve seen some great responses, but everybody else, again, even if you’re on dialysis and you have kidney failure, we can change the dosing of that chemo and patients do really well with CAR T. We work with the nephrologist, to make sure we don’t cause volume overload or anything else that they’re doing dialysis on time. We’re changing things up, etcetera. Patients with cardiomyopathy, so heart failure, again, we don’t want to go in when you have active heart failure, but just because you have a history of heart failure, we can do things to make sure that you don’t get, again, volume overload or, too much pressure on your heart.

Even patients with history of strokes, in the clinical trials that wasn’t allowed, but in the real world, again, as long as you’re not needing active therapy for your stroke, meaning, blood thinners, things like that yet anymore, then we can actually still potentially get you through CAR T. We have patients who aren’t able to speak.

They have expressive aphasia from history of stroke, but we actually have charts where we can figure out what their ICE scores are for ICANS. And we can make sure we, that they’re not having neurotoxicity. So we have other means by making sure that things are going well during that CAR T therapy that I think it’s really up to them. If they’re interested in it, my activation tip here is tell your doctor, “I’m interested in CAR T. I want to go talk to a CAR T center.” And that’s where they can tell you if something is possible or not. And I will say for the most part, most of my patients can get through CAR T. Again, we’ll talk about the different products. We’ll talk about how we would do it, how we would change it potentially.

But again, I have so many patients that are over a year, two years out without any therapy now. And they’re doing fantastically. And, and again, my patients with comorbidities and my older patients, they’re the ones who benefit when we’re not on any therapy because continuous therapy ends up causing more toxicity for them. And so I think it’s really, really important to speak up to your doctor and just say, this is something I’d really be interested in. And, any one of our centers would be happy to explain what we would do differently as well as, which product is the best one for you based on that risk comorbidity and the risk-benefit ratio.

Lisa Hatfield:

That again is great information. I’m glad you addressed the kidney dysfunction issue because we have several people in our support group who worry that they won’t be eligible for CAR T therapy because they have kidney dysfunction. So they’re all seeing specialists, which is the way to go for patients, to always see a specialist. So thank you so much, Dr. Patel.

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What CAR T Research Is Ongoing to Improve Treatment Response?

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What CAR T Research Is Ongoing to Improve Treatment Response? from Patient Empowerment Network on Vimeo.

 How can CAR T treatment response be improved with research? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses the CARTITUDE, KARMMA-9, and LEGEND studies and proactive patient advice about bispecific therapy and CAR T.

[ACT[IVATION TIP

“…before you start bispecific therapy, talk to your doctor about CAR T. And the reason I say that is that when you get a bispecific therapy, and currently that is not a fixed duration therapy, it is a continuous therapy. So patients are on it until they relapse. And the problem is that once you relapse on that T-cell therapy, your risk of losing BCMA, losing the antigen is much higher. There are mutations that we’re seeing that most patients get.”

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 CAR T-Cell Therapy Patient Eligibility | What Patients Should Know

CAR T-Cell Therapy Patient Eligibility | What Patients Should Know

Transcript:

Lisa Hatfield:

So, Dr. Patel, given the risk of relapse following initial CAR T therapy, what approaches are being investigated to enhance the persistence and durability of CAR T-cell responses in patients? I know there are a lot of theories out there saying things like antigen loss might be an issue, the loss of the target BCMA, T-cell exhaustion, the environment of the bone marrow, what of those theories are being investigated or looked at?

Dr. Krina Patel:

Yeah, I think without causing too many issues with why we think CAR T is so great, where it’s a one-and-done, right? That gives people this wonderful time off. In the relapsed/refractory setting, I think our goal is can we use CAR T to cure, right? That is the ultimate question. And, again, with cilta-cel (ciltacabtagene autoleucel) [Carvykti], with the original data from the LEGEND study, which was the original study in China, those patients had a little bit less therapy than CARTITUDE. However, there are about 15 percent of patients that are six years out from their CAR T still in remission, right?

And so that gives us a little bit of hope that maybe we’ll have a small tail and a small number of patients that are cured from our current CAR T approaches. But the question is, how do we now increase that tail and make it more like lymphoma? And then hopefully, 90, 100 percent of patients eventually, how can we, how can you get everyone cured? And so I think it comes down to myeloma is not the same for everybody, right? So you have our high-risk patients versus our standard-risk patients. And I think the strategies are going to be different for those two patient populations.

They already are in the way we treat patients with even induction therapy and maintenance and consolidation. We tend to be much more aggressive with folks who have high-risk disease versus those who don’t. And so, I think the biggest studies right now that are looking at this are really the combination studies. And so looking at CAR T followed by some type of maintenance, but fixed duration maintenance. So CARTITUDE 5 and 6 and KarMMa-9, these are all the studies of the BCMA CAR Ts in frontline. All of them will have maintenance afterwards, but it seems to be that they’re going to be two years of LEN maintenance and that’s it, nothing after that.

So LEN, lenalidomide (Revlimid), we know that it activates T cells. It activates other immune cells like NK cells in the body, even B cells. And so when you get cytokine release syndrome from the CAR T, you’re already making more of these immune cells and activating them. And now you’re going to have lenalidomide in there to kind of keep that going, right? And so that could help with this, not persistence of the CAR T itself, but persistence of better immune cells that can actually keep your myeloma down, right? So I think that’s one way.

The other way is some of the new therapies like CELMoDs. So these are sort of the newer version of lenalidomide and pomalidomide. They tend to have more immune effect than the other two drugs. So there’s studies looking at other CAR Ts, so a different target, right? So we talked about antigen loss. If you’ve lost BCMA, then what do we do?

Well, there’s other targets like GPRC5D. So a couple of the studies are looking at GPRC5D-CAR-T plus mezigdomide, which is one of the CELMoDs, or another arm is iberdomide, which is the other CELMoD, and looking at different doses without causing too many side effects, but still helping the T cell keep going, all kinds of things going on there. So those are some interesting studies.

And one of the cohorts, it’s actually using a GPRC5D-CAR-T with a BCMA bispecific after, that’s combinations. So now you’re targeting two different antigens and you’re using T cells in two different ways, right? And again, it’s fixed duration so that it’s not forever, but after a certain period, hopefully, we fix the bone marrow and we’ve killed enough myeloma that hopefully it won’t come back.

And so I think all of those are different strategies for the T-cell exhaustion to help with that, to hopefully keep from getting antigen loss, or if someone does have antigen loss, figuring out a way to go around it. And then the microenvironment I think is the biggest one, is how do we find cytokines and other things that can give us a bone marrow microenvironment that makes it really inhospitable for that myeloma to ever come back again.

So there are early Phase I studies looking at some of this, but I think down the line, that’s really what it will be, that once people go into their stringent CRs, MRD undetectable, now what can we do to keep that bone marrow from ever letting it grow again? And I think those are some interesting studies in the future.

Lisa Hatfield:

Okay. Thank you. So some patients are asked questions about the sequencing, and you’d mentioned different therapies. So I’ll ask this really quickly as follow-up, do you have any recommended or are there recommended sequencing of these different therapies like CAR T, then bispecifics, then CELMoDs, not all of them are FDA-approved at this point, but what are your thoughts on sequencing of those therapies?

Dr. Krina Patel:

So my activation tip here is that before you start bispecific therapy, talk to your doctor about CAR T. And the reason I say that is that when you get a bispecific therapy, and currently that is not a fixed duration therapy, it is a continuous therapy. So patients are on it until they relapse. And the problem is that once you relapse on that T-cell therapy, your risk of losing BCMA, losing the antigen is much higher. There are mutations that we’re seeing that most patients get.

So that means the next time we try to use a different BCMA therapy, there’s a big chance it’s not going to work. And we have small studies that show that, that people who get a bispecific, and then we try to go to CAR T for both CAR Ts that the response rates go down and the progression-free survival. So the months that patients get without, needing other therapy goes down for cilta-cel (ciltacabtagene autoleucel) [Carvykti], 33 months in CARTITUDE. It goes down to six months in CARTITUDE-2 where they did CAR T after prior BCMA therapy. That’s a huge drop.

In ide-cel, the real-world data, we saw that after bispecifics, you only get 2.8 months. If you get a CAR T, even though the response rates were still 70, 80 percent, it obviously there are clones that that BCMA isn’t there anymore that we can’t kill. And then it just grows back, right? The other way around, we actually see still a really good response because CAR T is a one-and-done, most of the time, you’re not going to lose BCMA.

So that let’s say a few years later, the myeloma was coming back. It usually has the same BCMA on there. So now I can use a bispecific. And yes, the PFS is still shorter than what you would see if you never had any BCMA therapy. It’s still in the realm of, almost a year, PFS though. So it’s much closer to what we see in the real world for bispecifics than the other way around for CAR T, it’s much, much lower. So we try to do CAR T first then bispecific, if possible. The other part is a T cell. So if you try to make T cells right after someone’s coming off of a bispecific, it is really hard to get T cells that are functional that then we can actually put a CAR into and make it work. So again, why, doing a CAR T first, and then a bispecific makes the most sense for the majority of our patients if they can do it that way.

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CAR T-Cell Therapy Follow-Up Monitoring | What Patients Can Expect

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CAR T-Cell Therapy Follow-Up Monitoring | What Patients Can Expect from Patient Empowerment Network on Vimeo.

What can CAR T-cell therapy patients expect for follow-up monitoring? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses how long follow-up monitoring is typically carried out, issues that are monitored for, and proactive advice for patients to help ensure optimal care.

[ACT[IVATION TIP

“…for long-term side effects really is infections, number one, because even after I just saw a patient last week whose IgG level’s still less than 100 even a year after CAR T. We’ve just knocked out the good and the bad, and so it was just a higher risk of infection, so we try to prevent by giving IVIG regularly, and so again, any time you get an infection, just talk to your doctors, don’t say, ‘This is just a cold,’ just make sure that someone’s following.”

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Transcript:

Lisa Hatfield:

Dr. Patel, if a patient is or has been part of a clinical trial involving CAR T, how long will that patient be followed under the clinical trial protocol for long-term effects, and this is especially important for people who see community oncologists and are wondering about any latent effects that they might experience, how long were those clinical trials follow those patients?

Dr. Krina Patel:

That’s a great question. So most trials will follow for at least two years just for toxicity, efficacy, now, most trials will follow until you’re relapsing, so that’s the point, is that we want to make sure this is working, that you don’t have any long-term toxicity, and when you relapse, we call that the progression-free survival, which is what most of the trials are looking at, and once you relapse, usually they’ll say, Okay, you’re coming off a trial because now you need other therapy and that could take years.

And however, for all CAR T products, because these are genetically modified, the FDA requires that you go into a long-term protocol where we’re monitoring for potential leukemias or lymphomas that T cells can cause, theoretically. So that is for 15 years, total. So everyone then is supposed to go on to that, now we can’t force you to go on to those, but it is something important because it’s come up recently that maybe some of these T-cell products are leading to leukemia or lymphoma, because we’re modifying those T cells could they themselves turn into a cell that causes cancer.

The theoretical risk has always been there, I will tell you that in reality, yes, there have been probably a handful of patients out of all the lymphoma and myeloma and leukemia patients who’ve been treated with CAR T where maybe it came from the T cell itself, the actual CAR T. The majority of other cases that have been reported, it’s been a low risk, it’s less than what we usually see in the general population of patients with blood cancers that get other blood cancers.

But when we see it, most of the time,  it’s not in the T cell where the CAR was in, but again, a handful have been, and that is really why as a group, we have to be really careful and make sure that some of the different. The way we make CAR T is very different amongst the products, and to make sure that one product versus another isn’t more likely to cause T-cell leukemias or lymphomas. So that’s the main reason why that 15-year protocol exists.

Lisa Hatfield:

And do you have any tips for patients who maybe have undergone CAR T therapy, are several years out and working with our community oncologist, what should they be watching for in terms of any late in side effects or long-term side effects?

Dr. Krina Patel:

So I think the activation tip here for long-term side effects really is infections, number one, because even after I just saw a patient last week whose IgG level’s still less than 100 even a year after CAR T. We’ve just knocked out the good and the bad, and so it was just a higher risk of infection, so we try to prevent by giving IVIG regularly, and so again, any time you get an infection, just talk to your doctors, don’t say, “This is just a cold,” just make sure that someone’s following.

And the other big thing is your blood count, so if your blood counts start doing something crazy, your white count’s getting high or too low, you’re not on any therapy, your hemoglobin is getting really low, your platelets are getting low, that’s where we want to make sure there’s not a secondary cancer, a secondary blood cancer involved. Again, T-cell leukemia myeloma was really rare, but we have seen 10 percent patients with MDS or AML in the relapse refractory population, so that is something else we would still want to watch out for and make sure we don’t miss that.

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What Are CAR T-Cell Therapy Requirements for Care Partners?

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What Are CAR T-Cell Therapy Requirements for Care Partners? from Patient Empowerment Network on Vimeo.

What requirements do CAR T-cell therapy care partners need to meet? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses CAR T-cell therapy care partner requirements, the reasoning for the requirements, and specific side effect conditions they need to be on the lookout for.

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 What CAR T Research Is Ongoing to Improve Treatment Response?

What CAR T Research Is Ongoing to Improve Treatment Response?

Transcript:

Lisa Hatfield:

With their caregiver eligibility requirements, does a patient have to have a caregiver with them during the initial part of the CAR-T therapy?

Dr. Krina Patel:

Yeah. So, unfortunately, if you’re going to do it with outpatient, then yes, because again, when things go wrong, they can go wrong pretty fast, especially with the ICANS, neurotoxicity. So ICANS, most patients just have a little bit of trouble writing or they might have a little bit of trouble with confusion, but if that happens, you might not remember or know who to call if you’re not feeling well, right.

Now when you’re in hospital, we actually say, No, you don’t need a caregiver with you, it’s nice to have somebody because we could pick up on things a lot faster, so if someone calls somebody the wrong name, it happens once in a while but they’re doing it consistently. I might not recognized that, but my patient’s caregiver will recognize it, they repeatedly, they called me this name instead of this name.

So little things like that, but at the same time, you don’t have to have a caregiver when you’re in the hospital because we’re watching you 24/7. So for that period that sometimes our patients stay for about a week or so, you don’t need somebody, but after that when you are outpatient, at least until you get home and you’re out of that period of ICANS and CRS, we do need somebody with you just to make sure if something bad doesn’t happen, and that if something is happening, they can call 911 or at least get you to the hospital relatively quickly. And that’s why there’s time limits, you can’t be farther than, for some trials, 30 minutes outside the hospital where you’re getting your CAR T.

So say two hours. Again, for us, we usually say 30 minutes is probably the longest, just because Houston, the traffic is so crazy too sometimes, that we want to make sure that you can get to the hospital quickly, even though it’s a lot less likely chance of getting high grade ICANS it’s less than 5 percent, but if you are that patient, we want to be able to get you into the hospital quickly and reverse it quickly.

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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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CAR T-Cell Therapy Patient Eligibility | What Patients Should Know

 What CAR T Research Is Ongoing to Improve Treatment Response?

What CAR T Research Is Ongoing to Improve Treatment Response?

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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A Look at Promising Strategies to Improve CAR T-Cell Therapy Access

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A Look at Promising Strategies to Improve CAR T-Cell Therapy Access from Patient Empowerment Network on Vimeo.

How can CAR T-cell therapy access be improved? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center explains strategies that have increased CAR T access, monitoring of CAR T patients, and advice for patients to access support.

[ACT]IVATION TIP

“…talk to your teams, if it’s not the doctor, at least the nurse practitioner or the nurses about resources, because through the pharmaceutical companies as well as things like LLS and other places, they actually have funds for people going through trials or CAR T therapies, etcetera, that we can help. My nurse knows all these things that she knows how to start working in our social worker and our case managers, they all know all these things so that they can get you the resources you need…”

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 Are CAR-T Clinical Trials Studying Use As a Frontline Therapy?

Are There Myeloma Trials Investigating CAR T for Frontline Therapy?

Transcript:

Lisa Hatfield:

Dr. Patel, given the exacerbation of existing barriers during the COVID-19 pandemic, what strategies do you believe are most promising for enhancing patient access to CAR T therapy, particularly in terms of innovative clinical trial designs and stakeholder collaboration? And one of the questions that comes up a lot is during COVID I was able to participate in a clinical trial, but I could do some things closer to home where we don’t have a big center. Are those strategies still in play? So patients might be able to travel, maybe once a month or once every two months for a CAR T trial and then go home for a little while. Can you talk about that a little bit?

Dr. Krina Patel:

Yeah, I think COVID did help us learn how to use telehealth much more, where when it was allowed, I think the good news when we had it, we could do it for all 50 states. It was amazing. All my patients I could talk to through virtual visits, etcetera, use their local labs. Clinical trials are a little harder because you have to have labs that are certified and making sure that they’re able to do those intricate labs that you need.

For instance, certain things are central labs for where they have to look at your T cells and how they’re expanding over time while you’re getting CAR Ts. So we call those central labs because those are labs we draw and send to the company, to whatever lab they’re using to help with that stuff. Things like CBC, your blood counts, your kidneys, liver. Yes, those things are easy to get anywhere. There are multiple labs like Quest and Labcorp, etcetera, that can do those.

So I think those are things that we can help with. It’s the first 30 days of any CAR T study that for safety reasons right now, we still say you have to be at the center where you’re getting the CAR T on trial or even off a standard of care. And that’s more for if you get one of these toxicities like the delayed neurotox or an infection, that we can get you back into the hospital if needed or at least get you diagnosed really quickly and treated quickly.

But yes, after those 30 days, at least most of our CAR T studies really try to limit how often you have to come in. So once a month is pretty typical and then once every three months after the first couple of years, and then once a year if that. I hope that with the FDA and with our sponsors, our pharmaceutical companies that run these trials, that they can really help get these things, the logistics figured out, because that’s what it ends up being. Once you’re done with your first at least three months of CAR T, we know patients are going to do well. And it’s really about whatever labs and visits we need to do, how can we do them virtually? And again, if my sponsors and the FDA would allow that, we’d be really happy to.

And I know the FDA is all for it. They are trying to help increase access as well. And so some of the bigger centers like us, and I think Sloan Kettering and City of Hope and Mayo, we also have other centers that are outside of the main campus. So MD Anderson doesn’t have other hospitals the way Mayo does. So Mayo has Arizona, has Rochester, and Florida. MD Anderson has a sister network.

And so we’re hoping to tap into that one day, because there are places everywhere. And if we can do that, that would actually help get access to a lot of these novel therapies a lot faster to our patients. And within Houston, just being such a big city, we have four other centers out in the outskirts and we are trying to actually increase our abilities to do therapies there as well, including CAR T and bispecific therapies.

Lisa Hatfield:

Thank you for that, Dr. Patel. So one question, I have a follow-up question. If a patient has to travel, maybe they live in an area where there is no academic center, they’d have to travel for a clinical trial. And you mentioned the first 30 days. Are patients usually, one of the big challenges is financial, is a financial challenge. Are patients sometimes feeling well enough during that 30 days if they can work remotely? Can they work remotely while they’re at your institution for 30 days? Is that pretty typical or is that something you don’t see very often?

Dr. Krina Patel:

Yeah, no, that’s a great question. So we are trying to make the whole thing outpatient soon, and a lot of our trials are allowing for CAR T outpatient, and only if you get a fever, then we admit, most people do get admitted because most people get fevers from the CAR T, but for the most part patients still feel well, it’s not that they’re having this horrible nausea, vomiting, diarrhea, things that we think about with auto transplant, where people really can’t work because they’re just exhausted. The majority of our patients are bored in the hospital, it really is that we’re just there just in case the fever turns into something worse. So a lot of my patients who are still working actually do work remotely, I can think of a few just this past week that talked about the fact that they were able to do this.

And I think the other piece we have so many resources. And again, the big activation tip here is talk to your teams, if it’s not the doctor, at least the nurse practitioner or the nurses about resources, because through the pharmaceutical companies as well as things like LLS and other places, they actually have funds for people going through trials or CAR T therapies, etcetera, that we can help.

My nurse knows all these things that she knows how to start working and our social worker and our case managers, they all know all these things so that they can get you the resources you need and some of the centers, our academic centers have resources as well. We have housing for free, you have to sign up for it in advance, but you might be able to get housing for free for that whole 30 days, and so there’s a lot of different resources that you just have to ask about, and then again, through our social worker, case manager, nurses, and sponsors. We can actually get some of that for you too.

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Are There Myeloma Trials Investigating CAR T for Frontline Therapy?

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Are There Myeloma Trials Investigating CAR T for Frontline Therapy? from Patient Empowerment Network on Vimeo.

Is it possible for CAR T-cell therapy to be used as a frontline therapy? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center sits down with her patient, Lisa Hatfield to discuss CAR T-cell clinical trials, including CARTITUDE-4, KarMMa-2, and KarMMA-9, and trials currently under study. 

[ACT]IVATION TIP

“…talking to a myeloma specialist about different options that are out there for trials because different centers will have different trials that are open and you need someone to help you navigate with that. Which ones are the best ones for you? And then I would say talking to your patient advocacy groups, because that’s really where a lot of my patients hear the information. And then they come to me and say, ‘Listen, I heard this, what does it mean?’ And I think that really helps you kind of even know where to start from.”

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Related Resources:

How Can Variable Patient Groups Be Addressed in CAR T?

How Can Variable Patient Groups Be Addressed in CAR T?

 What Patient Types Are Good Candidates for CAR-T Therapy?

What Patient Types Are Good Candidates for CAR T-Cell Therapy?

 A Look at Promising Strategies to Improve CAR T-Cell Therapy Access

A Look at Promising Strategies to Improve CAR T-Cell Therapy Access

Transcript:

Lisa Hatfield:

So, Dr. Patel, for this next question, I’m going to preface it by saying that anybody that I have ever talked to in my advocacy work about myeloma and how to get care for myeloma, I’m a huge advocate for seeing a myeloma specialist. And I will tell everybody out there that Dr. Patel at MD Anderson is my myeloma specialist, and I’ve been with her since I was diagnosed in 2018. I live in an area where we don’t have any myeloma specialists. And so I’m an advocate for that. And anybody listening, I hope that they know that they can seek out the care of a specialist even for initial consult or even once throughout their journey.

Having said all that, I know Dr. Patel, because you’ve talked to me about them before, that you’re involved in some clinical trials for CAR T therapy. Can you talk a little bit about your trials that you’re doing right now that offer CAR T in earlier lines of therapy, including frontline therapy, and what this could mean for patients?

Dr. Krina Patel:

Yeah, no, I think the CAR T trials are what allowed us to even get to second and third line. The KarMMa-3 and  CARTITUDE-4 were the two trials that brought ide-cel (idecabtagene vicleucel) [Abecma] and cilta-cel (ciltacabtagene autoleucel) [Carvykti] forward, which is fantastic. And I think now it’s how can we improve even further? So some of our clinical trials are even earlier line, like you said, frontline. So we have one called KarMMa-9 that is for patients who have less than a VGPR, meaning that they didn’t get all their myeloma gone after their initial transplant, if they went to transplant, you can do consolidation with CAR T. And we’ve had a few patients that we did on a smaller study called KarMMa-2 that are doing really well after they were on that cohort for that study.

So that’s sort of why they’re doing a bigger study for FDA approval now. And then CAR T 2-5 and 6, we don’t have that at MD Anderson, but a lot of centers do. But that is now trying to see if cilta-cel can actually beat stem cell transplant, which again, a lot of us are really excited about, but we need to do the trial to make sure it’s just as safe and hopefully more efficacious. So I think those are really, really important. Auto-transplant, I was a transplanter when I first became faculty at MD Anderson.

And so I do think it has a role, but it’s high-dose chemo and there are secondary potential side effects that can happen. And people really have to kind of stop their lives for at least two, three months, if not longer, to go through that. Where in CAR T, I think it’s that quality of life piece. Again, it’s one and done. It doesn’t take as long to recover for the majority of patients. And it really is using immune therapy instead of chemo to kill that myeloma, right? So it is very different.

And we’ve seen some amazing depth of response for CAR T compared to what we see with the normal chemotherapy. So the other piece is how we have other trials that are doing earlier lines. So there’s new CAR Ts that are coming out, hopefully in the near future as a standard of care. So there’s one called ddBCMA. It’s a study by Arcellx. And the big news was that Kite, which is one of the big lymphoma CAR T companies, just took over to do their big Phase III study.

So hopefully we’ll have FDA approval for this in the next year with our Phase II study. But the Phase III will be in second line forward just like the CAR T 2-4 was. And this CAR T, it’s different in the way it’s built. And we really don’t see any of the neurotoxicity at all so far, which has been pretty impressive. But we see the same efficacy that we saw with cilta-cel. So this could be sort of best of both worlds, knock on wood. But so far we’ve seen some really great responses. And I think that trial being offered earlier will be great as well for a lot of our patients to get something that might be better than what we have already. The other trials are with other targets.

So we do have some studies that are looking at different targets instead of BCMA. So now we have patients who have already had CAR T with BCMA and over time, years, for the most part, they’re relapsing. And so now we have GPRC5D CAR Ts that are actually being combined with different things to then be able to give them a little bit earlier rather than waiting till after BCMA or fifth line, etcetera. So we have lots of trials looking at all different ways to combine CAR Ts or newer versions of the BCMA CAR Ts that I think are really, really exciting. And I think it’s really hard to keep up with this.

So my activation tip here is really talking to a myeloma specialist about different options that are out there for trials because different centers will have different trials that are open and you need someone to help you navigate with that. Which ones are the best ones for you? And then I would say talking to your patient advocacy groups, because that’s really where a lot of my patients hear the information. And then they come to me and say, “Listen, I heard this, what does it mean?” And I think that really helps you kind of even know where to start from.

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How Can Variable Patient Groups Be Addressed in CAR T?

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How Can Variable Patient Groups Be Addressed in CAR T? from Patient Empowerment Network on Vimeo.

Can CAR T-cell therapy address variable patient groups? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses variances in different myeloma patient groups, the KarMMa-3 study, and proactive advice for patients.

[ACT]IVATION TIP

“…if you are in a area, let’s say rural America where you don’t have access or you are in a minority population, African American, Hispanic, etcetera, or older, frail patients who are older that are considered vulnerable as well, absolutely make sure to talk to your doctors about these novel therapies because you still can get them safely and they will work. They can work. You just have to go to a center where they know how to adjust those types of therapies to make sure you get the best options out there as well.”

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Related Resources:

What Patient Types Are Good Candidates for CAR-T Therapy?

What Patient Types Are Good Candidates for CAR T-Cell Therapy?

 Are CAR-T Clinical Trials Studying Use As a Frontline Therapy?

Are There Myeloma Trials Investigating CAR T for Frontline Therapy?

 A Look at Promising Strategies to Improve CAR T-Cell Therapy Access

A Look at Promising Strategies to Improve CAR T-Cell Therapy Access

Transcript:

Lisa Hatfield:

Dr. Patel, how might the heterogeneity of patient populations impact the standardization and reproducibility of CAR T therapy outcomes across different clinical settings, and what initiatives are in place to address this variability?

Dr. Krina Patel:

Yeah, I think that’s a great question because again, this is a personalized therapy. So it depends on what your myeloma is like, the genomics, the genetics of your myeloma, how aggressive is it, plus your T cells, right? And so everybody’s genetic ancestry, etcetera, is very different. So the idea of a personalized medicine, more than just even across groups of people, it’s at the individual level. And I think when you talk about different races or ethnicities, we have seen some differences in our real-world data, in very relapsed/refractory patients, where people can get great response rates still.

So, for instance, Caucasian patients versus African American patients, our response rates are still high in the 80s and 90 percent, but the toxicity is a little bit higher in our African American patients. It’s still not high grade. It’s not anything that makes me say, I’m not going to give this, but the baseline inflammatory markers are a little bit higher. And so once we get the CAR T, our patients tend to get a little bit more CRS.

They end up in the hospital a little bit longer. Now, again, this is a multivariate analysis and we couldn’t find any other difference, but when we look at KarMMa-3, which is one of our big studies that led to ide-cel (idecabtagene vicleucel) [Abecma] being approved early, we actually had an outcomes of African American patients only that we looked at and that we presented just this past TCT, and response rates were actually a little bit better.

Again, you can’t compare them because the numbers aren’t there to power that to compare, but numerically the numbers were better in terms of response rate, in terms of progression-free survival, it was actually more months that it beat the standard of care and we didn’t see more toxicity.

And so I think we do need to look at these things and make sure there’s not one group of patients has a lower efficacy for some reason, and why is that and how can we improve that? And so far, we don’t really see that. And the other is the toxicity piece, to make sure that these therapies that do cause some strange toxicities that we’re watching and seeing who might be more vulnerable to those toxicities, who do we need to maybe even prevent, do prevention strategies for, but so far we haven’t seen it.

And then I think coming back to the individual, right?So again, all of us have these different T cells that have different mutations in them, and some folks, for some reason, even with less myeloma, their T cells just expand really fast and other folks, they don’t. And so in the future to get best outcomes, we need to see how we can turn the volume lower for those folks who have really sensitive T cells.

And for those who don’t, how do we, what else can we add in combination to actually increase those T cells so that they’re actually doing a better job at killing the myeloma, right? And including the microenvironment too. So I think there’s a lot of translational work as well as the epidemiology side of things to say, okay, how do we first diagnose the problem, find the problems, and then how do we figure out how to intervene to then improve outcomes for all our patients? I think the activation tip here is that if you are in a area, let’s say rural America where you don’t have access or you are in a minority population, African American, Hispanic, etcetera, or older, frail patients who are older that are considered vulnerable as well, absolutely make sure to talk to your doctors about these novel therapies because you still can get them safely and they will work. They can work. You just have to go to a center where they know how to adjust those types of therapies to make sure you get the best options out there as well.

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What Patient Types Are Good Candidates for CAR T-Cell Therapy?

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What Patient Types Are Good Candidates for CAR T-Cell Therapy? from Patient Empowerment Network on Vimeo.

For CAR T-cell therapy, what patient types are good candidates? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses patient situations that qualify them for CAR T-cell therapy and shares proactive patient advice.

[ACT]IVATION TIP

“I think a lot of people have this misunderstanding that CAR T isn’t for everybody, but I will say it’s actually more likely that you’re going to be eligible for CAR T over auto transplant. So I think it’s just bringing it up, talking to them, and seeing a specialist to discuss which ones are the right one for you and when to go.”

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Related Resources:

How Can Variable Patient Groups Be Addressed in CAR T?

How Can Variable Patient Groups Be Addressed in CAR T?

 Are CAR-T Clinical Trials Studying Use As a Frontline Therapy?

Are There Myeloma Trials Investigating CAR T for Frontline Therapy?

 A Look at Promising Strategies to Improve CAR T-Cell Therapy Access

A Look at Promising Strategies to Improve CAR T-Cell Therapy Access

Transcript:

Lisa Hatfield:

Dr. Patel, given that CAR T is approved for earlier lines of therapy, can you describe the type of disease characteristics of patients that are likely to be considered first for CAR T?

Dr. Krina Patel:

Yeah, I think it’s a really exciting time, we got approval for two different CAR Ts that were approved in fifth line. So patients had to relapse four times before they could get to CAR T therapy. And now one of them, cilta-cel ciltacabtagene autoleucel [Carvykti], is approved in second line, so people have to relapse once before they can get it.

And the other CAR T, ide-cel (idecabtagene vicleucel) [Abecma], is approved in third line, so you have to relapse twice. There are reasons why that is the way it is, but both of these CAR Ts are pretty fantastic, and we’re really excited that more patients will now have access. As you can imagine, relapsing once, it’s already hard enough to then say, okay, I need a different therapy, but to go through four times before you can do something like CAR T is really, really important.

So I think the biggest characteristic, and I would say for my patients, it’s really their ability to keep their myeloma controlled for at least six to eight weeks, potentially, right? Because this is a personalized therapy, unlike most other myeloma therapies where we have to take the T cells out, we have to then send them to a lab to make the CARs, then it takes about four to six weeks to get them back. During that time, I just have to know that your myeloma can stay controlled or even improve with whatever bridging therapy we decide to do during that time.

And we know that when patients have myeloma that is on its way down, that it’s actually improving, by the time they get to the CAR T therapy, the infusion part, they tend to do better in terms of efficacy, but also have less toxicity. So there’s a few different toxicities that we can talk about with CAR T that are very distinct compared to most other therapies, that again, if you have less disease burden, the rates of that toxicity and the high-grade toxicity goes away, right? It’s much, much lower than if you have a lot of myeloma coming in.

So, again, for my patients who have disease that I know I have other therapies to keep it knocked down or to knock it down during that bridging, that really is the main difference between, can I take this patient to CAR T or not? But I think there’s some nuances too, again, that idea that one CAR T is approved in second line, another one is approved in third line, I do think they’ve never been tested head to head, so we don’t have data in a clinical trial, but in the real world, we’ve used both of these products, a lot of us have, and I think most of us will say that one of the products is probably stronger, it probably works better cilta-cel, and that is the one that’s approved in second line, which is great.

So for my fit patients who don’t have a lot of comorbidities, who do really have high-risk disease that I need to be as aggressive as possible and do something very different, hands down, it makes sense that cilta-cel is the right thing to do right at second line, but the toxicity is also a little bit higher with that, meaning that patients are more likely to potentially get some of these strange neurotoxicities that we see, that we didn’t really see before with other therapies, some of our myeloma patients get neuropathy and we think about that as neurotoxicity, but this is different.

This is more patients after 30 days of having had their T cells can all of a sudden get a facial palsy where they’re having drooping of their face and it can affect their eating and their speaking. Now those things are not fatal, we can treat it with steroids, things like that, but they can affect your quality of life. And if it doesn’t resolve, that can affect down the road, all the other therapies we want to give you, right? But the more dangerous one is something called delayed Parkinsonianism or delayed motor neurotoxicities.

And again, we know the best prevention of that is decreasing the myeloma burden before going to CAR T, but if we can’t do that or some patients can still potentially get this Parkinsonianism, we really want to make sure there’s a risk-benefit discussion, right? That we say, okay, this is why we should go in second line.

Again, the risk is less than 1 percent now based on how we’ve done things for prevention. But on the other hand, with ide-cel, most of our patients, even on dialysis, our patients that are getting CAR T and doing well, patients with heart failure, I’ve had a 90-year-old go through ide-cel without any issues and have great responses. So I think both of these offer, one of the first times they offer time without any therapy for myeloma. And so I would say this is something most of my patients should ask their physicians about, but really then it’s nuanced in terms of when we should do it and which product.

Lisa Hatfield:

Okay, thank you. And do you have an activation tip for that question, Dr. Patel?

Dr. Krina Patel:  

Yeah, so I think the activation tip here is bring it up, bring up CAR T to your doctors, right? I think a lot of people have this misunderstanding that CAR T isn’t for everybody, but I will say it’s actually more likely that you’re going to be eligible for CAR T over auto transplant. So I think it’s just bringing it up, talking to them, and seeing a specialist to discuss which ones are the right one for you and when to go.

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Can Race or Ethnicity Impact CAR T-Cell Therapy Response?

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Can Race or Ethnicity Impact CAR T-Cell Therapy Response? from Patient Empowerment Network on Vimeo.

Can CAR T-cell therapy response be impacted by patient race or ethnicity? Expert Dr. Sikander Ailawadhi from Mayo Clinic discusses some impacts to CAR T-cell therapy response for African Americans and some clinical methods to help reduce impacts to patients.

[ACT]IVATION TIP

“…there is a lot of work happening, research happening around how to predict and prevent side effects from CAR T so that the patients are much more informed, aware, can make an informed decision, and as clinicians, we can do whatever is within our control and is at our disposal to help prevent those side effects and make CAR T an even safer and more beneficial treatment for patients.”

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Related Resources:

How Can Equitable CAR T-Cell Therapy Access Be Increased?

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 How Can Information Disparities on Emerging Therapies Be Addressed?

How Can Information Disparities on Emerging Therapies Be Addressed?

 How Are Rural CAR T-Cell Therapy Barriers Being Addressed?

How Are Rural CAR T-Cell Therapy Barriers Being Addressed?

Transcript:

Lisa Hatfield:

Dr. Ailawadhi, is there data around ethnicity and response to CAR T-cell therapy and whether genetic factors may affect treatment outcomes? And can the side effects of CAR T-cell therapy be predicted or prevented?

Dr. Sikander Ailawadhi:

So Lisa, a very important question of whether there are racial ethnic factors that can affect CAR T-cell therapy benefit or side effects, and what are we doing to prevent some of these side effects? We know side effects can happen, what can we do to actually prevent them? So I’ll take this question in two different subgroups. The first one of talking about racial ethnic groups or differences. So we know patients who are African Americans. This is one study reported that African Americans are more likely to have side effects from CAR T-cell therapy.

So while it’s not a specific “genetic factor,” but race ethnicity can sometimes be associated with more side effects, and that is just because these are very inflammatory delivered or inflammatory mediated side effects like CRS. It’s also important to know that there are certain other factors, disease or treatment-related factors, that can help predict potentially more side effects with CAR T. For example, patients who are very heavily pre-treated, patients who have a very high disease burden, patients who did not respond to bridging therapy that was given to them prior to the CAR T.

These are all factors where we know that side effects are going to be more, and the success of the treatment might be lesser. What we are trying to do to mitigate some of these side effects, there are now studies which are giving either some low doses of steroids as a prophylaxis before, right around the time of CAR T, so that side effects may not happen. Studies that are giving a low dose or even standard dose of what’s called tocilizumab (Actemra), toci, or tocilizumab.

This toci drug is an antidote for CRS or cytokine release syndrome. The thought is, well, why wait for the toci to be given after the side effect happens? Why not give it beforehand and prevent the CRS? Historically, there was a concern that steroids or toci given early on could affect the CAR T-cell viability or activity, but that’s not the case. For example, in lymphomas, there are clinical trials that have shown very clearly given prophylactic or preventative steroids could help. Using steroids or toci in a preventative manner is helping mitigate some of the side effects. 

Well, by preventing the side effects, we are being able to give the treatment in a way that the patients may have lesser side effects and can get it done closer to home or at home sometimes, and their time to stay in the hospital is lesser. You can imagine that some of these barriers are being further mitigated.

My activation tip for this question is that there is a lot of work happening, research happening around how to predict and prevent side effects from CAR T so that the patients are much more informed, aware, can make an informed decision, and as clinicians, we can do whatever is within our control and is at our disposal to help prevent those side effects and make CAR T an even safer and more beneficial treatment for patients.

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How Are Rural CAR T-Cell Therapy Barriers Being Addressed?

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How Are Rural CAR T-Cell Therapy Barriers Being Addressed? from Patient Empowerment Network on Vimeo.

How are barriers to CAR T-cell therapy care in rural areas being reduced? Expert Dr. Sikander Ailawadhi from Mayo Clinic discusses positive patient care developments from COVID and how patients can help optimize their care.

[ACT]IVATION TIP

“…over these past few years, post-COVID, we have learned how to deliver healthcare in a more patient-centric manner, and we are using those factors, those tools, those techniques, to be able to bring CAR T and its associated care to a lot of many more patients. I still would like patients to seek out care as and when possible.”

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How Can Equitable CAR T-Cell Therapy Access Be Increased?

How Can Equitable CAR T-Cell Therapy Access Be Increased?

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How Can Information Disparities on Emerging Therapies Be Addressed?

 Can Race or Ethnicity Impact CAR T-Cell Therapy Response?

Can Race or Ethnicity Impact CAR T-Cell Therapy Response?

Transcript:

Lisa Hatfield:

Dr. Ailawadhi, logistical challenges exist in delivering CAR T-cell therapy to patients, especially in rural or underserved areas. Can you speak to any innovative delivery models that could improve access?

Dr. Sikander Ailawadhi:

This is an extremely important, but also an exciting question to ask, Lisa, whether we have some interesting models or innovative healthcare delivery models that are trying to overcome some of these access barriers to CAR T-cell therapy. So, one thing that COVID has taught us is that medicine does not need to be delivered or healthcare does not need to be delivered in a cookie cutter fashion as we were doing it before. Suddenly, after COVID, I’m glad that we all as a community, as a society, pivoted and started delivering telemedicine care.

So, we are still doing a lot of telemedicine. I’ll give you the example of one case who’s near and dear to me, because she did come through a lot of adversity to get to this point. A relatively younger lady with multiple myeloma, who’s an international patient, and she came from Middle East, she had already received two transplants and had run through all the treatment options available locally.

She had some family members and some means that she could actually come here, so she came to the U.S., did a consult, we did a visit, we took over her treatment, she got CAR T, but then a month or so after that she was doing fine and she wanted to go back home. She was here with some family members living in a foreign country, not speaking the language, et cetera. Her children were very supportive and spoke English. So, she went back and I still continue to do video visits with her just to see how she’s doing, monitor her disease, she sends me records through the electronic medical system portal, I can see her labs, and I think it gives me peace of mind that I’m keeping an eye on it, it gives her peace of mind.

And I don’t think a lot of it would have been possible without the tools that we have at our disposal, now, for example, telemedicine. Now, certain institutions do have other opportunities, like they have mobile clinics, they will actually go to the patients where they are. We, for example, at Mayo Clinic in the Midwest, in Minnesota, we have a health system that is present throughout three different states in the Midwest, where we have smaller clinics where the patients could go to and receive all their care, except for the CAR T portion for which they can come to the main site.

We also have something set up, for example, at Mayo called remote patient monitoring. We have something called acute care at home, in which we are providing a lot of this CAR T-cell therapy as an outpatient. Patients can receive their cells but can be discharged very early. And then a lot of these remote monitoring services we are using to help patients stay where they are, feel safe, not being stuck in a hospital room, and are able to receive their care sometimes in their homes with their caregivers and family members by their side, and they feel more comfortable about it.

So a lot of these things that we are doing to provide access to care to patients, and I would also say, this is helping overcome some healthcare disparities also, because some of those patients who have challenges or barriers to the access, but by doing these innovative things of telemedicine, at home care, remote monitoring care, et cetera, we are suddenly overcoming some of those barriers. For example, the patient needing to go to the hospital, the patient needing to have a caregiver who has to miss time from work just because they have to be at the hospital, et cetera.

So my activation tip for this question is that over these past few years, post-COVID, we have learned how to deliver healthcare in a more patient-centric manner, and we are using those factors, those tools, those techniques, to be able to bring CAR T and its associated care to a lot of many more patients. I still would like patients to seek out care as and when possible.

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How Do Race and Ethnicity Impact CAR T Side Effects?

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How Do Race and Ethnicity Impact CAR T Side Effects? from Patient Empowerment Network on Vimeo.

How are CAR T side effects impacted by race and ethnicity? Expert Dr. Sikander Ailawadhi from Mayo Clinic shares some research study results about CAR T response rates and disease progression in African American and Hispanic patients and solutions for clinicians.

[ACT]IVATION TIP

“…there are some differences by race, ethnicity, specifically for the side-effect profile, patients should be aware of it, and clinicians who are the CAR T specialists should be aware of it so that they can manage the side effects well in their patients.”

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Related Resources:

How Can Equitable CAR T-Cell Therapy Access Be Increased?

How Can Equitable CAR T-Cell Therapy Access Be Increased?

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How Can Information Disparities on Emerging Therapies Be Addressed?

 Can Race or Ethnicity Impact CAR T-Cell Therapy Response?

Can Race or Ethnicity Impact CAR T-Cell Therapy Response?

Transcript:

Lisa Hatfield:

Dr. Ailawadhi, real-world data from one of the available CAR-T-cell therapies, ide-cel (Abecma), has shown some differences in the side effect profile and benefit by patient race and ethnicity. What is your take on this, and how do you utilize this in your clinical practice? And also, what do you think researchers should do next to learn more about how CAR T therapies affect different people?

Dr. Sikander Ailawadhi:

This is an extremely important question, looking at what is the data currently on the risks and benefits of CAR T-cell therapy in patients from different racial ethnic groups, and then how are we using that in the clinic today and where should the field go about research in this area. So, Lisa, you’ve correctly pointed out that this study that was published recently is based on some real world data from one of the CAR T cells available, ide-cel.

Now, I shouldn’t say that this is specifically to ide-cel, but basically, ide-cel has been around a little bit longer than cilta-cel (Carvykti), and so the real-world data on ide-cel was to the point that this racial ethnic analysis could be done, and it was reported. That said, we don’t know how cilta-cel would be. That data just does not exist. So, I’m not saying that this is applicable to cilta-cel or not, because at least this study was specifically for ide-cel because that data was mature enough to be reported. That was just a qualifier of this particular question.

Now, what that study showed was that some of the side effects, including CRS, the cytokine release syndrome, and certain markers that can be an accompaniment of CRS, like the ferritin or what’s called CRP, C-reactive protein, which are inflammatory markers. So, inflammatory markers were higher in African Americans, and the CRS was also higher in African Americans from that real-world data.

The other thing that it showed was that the response rates were lower in Hispanics, but the progression-free survival, meaning time it took for the disease to progress and require more treatment, was lower in African Americans or overall survival was same across the racial ethnic groups. So, side effects a little bit more in African Americans, and the immediate response, a little bit less in Hispanics, but overall outcome, similar across races. Now, this is important for us to know because African Americans tend to have certain inflammatory disorders more frequently, like even asthma is seen more frequently in African Americans.

So, CRS, which is an immune system mediated inflammatory response, I can imagine that some of it might be higher in African Americans. So, in our clinics, what we are doing is when we are monitoring the patients, every patient is getting monitored the same way, but when it’s an African American patient, we are putting a little bit more focus on those inflammatory markers that can sometimes start showing up even before the CRS happens. I don’t think the response rate portion of Hispanics that we’re really taking into account much because the overall outcome or the long-term outcome was not really different between races and ethnicities.

Of course, there needs to be much more research, so I think we need longer-term follow-up data, we need larger number of patient data, and what I alluded to in the very beginning, we do need data on cilta-cel also, which has not yet been presented, but we are hoping that it will come out very soon. So, my activation tip for this question is, that there are some differences by race, ethnicity, specifically for the side-effect profile, patients should be aware of it, and clinicians who are the CAR T specialists should be aware of it so that they can manage the side effects well in their patients.

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How Can Information Disparities on Emerging Therapies Be Addressed?

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How Can Information Disparities on Emerging Therapies Be Addressed? from Patient Empowerment Network on Vimeo.

How can gaps in information about emerging myeloma therapies be reduced? Expert Dr. Sikander Ailawadhi from Mayo Clinic discusses some demographic characteristics of information disparities and advice for myeloma experts and patient advocates to help bridge  information gaps.

[ACT]IVATION TIP

“…I would highly encourage all my fellow clinicians, educators, researchers, and myeloma academicians to please consider developing some of these thresholds in your clinics so that if a patient is even able to come through the door and sees you, they are able to gain access to resources, or you’re able to bring together higher amount of resources specifically for that patient’s needs.”

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How Do Race and Ethnicity Impact CAR T Side Effects?

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How Are Rural CAR T-Cell Therapy Barriers Being Addressed?

Transcript:

Lisa Hatfield:

Recent studies have identified demographic characteristics such as higher education, residency in certain regions, and urban or suburban living as factors influencing awareness and understanding of novel myeloma treatments. How can healthcare organizations tailor educational initiatives to reach underserved populations and address these disparities in access to information and understanding of emerging therapies?

Dr. Sikander Ailawadhi:

Lisa, this is a very interesting and important question. And as you were pointing out, studies that are talking about education level residency in certain geographical regions or urban/suburban areas, and that may be affecting the patient’s understanding and awareness of novel myeloma treatments. I kind of smile a little bit because one of those studies is ours that we conducted in about close to 2,300, 2,400 patients where we surveyed patients about CAR T-cell therapy and bispecific antibodies.

And what we found out is that there were a lot of differences. Patients with higher education where their information was closer to the correct information. I mean, there are sometimes gaps everywhere, but the patients with lower education in certain parts of the country or who identify as being from a rural area, they tend to have many more gaps and misconceptions about treatments.

So, while it was a novel finding, I wasn’t really surprised in seeing that. Because historically, our patients who are in rural areas, who are lower income or lower education strata, they tend to be underserved and underrepresented and just underserved. So what we’re trying our best to do is when we create the education initiatives, we are trying to, one, disseminate it across the board. So for example, studies like this, study gives results. We are working on writing the manuscript and publishing it so that anybody and everybody can read that and find out and say, “Oh, you know what, this is something that the people over at Mayo Clinic in their study found. Most likely it is applicable to us also.

So either we should look for that finding, or we should just try to mitigate it. We should just work on it.” So developing the education material and spreading it far and wide, we are strongly considering also that the results of these studies should be shared with our patients. Why not? I mean, forums like this or even for that matter, our other support group programs and other education initiatives, we are trying to disseminate these study results with the patients because they need to know about it.

And then when we are…as you rightly asked, how are we tailoring these education initiatives? I think the idea is we are trying to disseminate it far and wide. We are also trying to share it with institutions that may have a larger catchment population of these underserved groups. And then when we are putting together these initiatives, these education initiatives…or I should say, from a different standpoint, when patients come to our institution, we have certain triggers that we have set up.

So if somebody is African American or Hispanic, or if somebody in the EMR, in the electronic medical record system, has identified themselves coming from a rural area background, or if somebody has what’s called certain social determinants of health that are captured by the electronic medical record, and if they have some flags there, I think my threshold of getting a social work consult for that person or providing extra education material, that threshold goes down. We have that set up in our clinics.

So certain characteristics will qualify the patient to be able to access more information just because we feel that that is the group that tends to be traditionally underserved. So my activation tip for this question is, while we will try our best to provide information as far and wide as possible, I would highly encourage all my fellow clinicians, educators, researchers, and myeloma academicians to please consider developing some of these thresholds in your clinics so that if a patient is even able to come through the door and sees you, they are able to gain access to resources, or you’re able to bring together higher amount of resources specifically for that patient’s needs.

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How Can Equitable CAR T-Cell Therapy Access Be Increased?

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How Can Equitable CAR T-Cell Therapy Access Be Increased? from Patient Empowerment Network on Vimeo.

How can CAR T-cell therapy access issues be reduced? Expert Dr. Sikander Ailawadhi from Mayo Clinic explains some common access issues that can arise for patient CAR T care and some ways that providers and patient advocates are raising awareness about support resources.

[ACT]IVATION TIP

“…from a patient’s standpoint and role, while institutions are trying their best to provide the care wherever they can, from a patient standpoint, understanding what might be the specific barriers in their case to get to CAR T and trying to get to an institution that has the resources to help overcome and mitigate some of those barriers would be very important.”

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Related Resources:

How Can Information Disparities on Emerging Therapies Be Addressed?

How Can Information Disparities on Emerging Therapies Be Addressed?

 How Do Race and Ethnicity Impact CAR T Side Effects?

How Do Race and Ethnicity Impact CAR T Side Effects?

 How Are Rural CAR T-Cell Therapy Barriers Being Addressed?

How Are Rural CAR T-Cell Therapy Barriers Being Addressed?

Transcript:

Lisa Hatfield:

How can healthcare systems ensure equitable access to CAR T-cell therapy for all eligible patients, regardless of demographic or economic factors?

Dr. Sikander Ailawadhi:

Lisa, it’s an important question of how do healthcare systems, what role they can play in providing equitable access to CAR T-cell therapy or care in general. And I think it’s also important to figure out what is the patient’s role in this, in addition to the healthcare system’s role. So, there are some institution-specific things, I don’t want to say issues or problems or whatever concerns, but things that sometimes can be barriers or sometimes are non-modifiable. For example, the type of insurances that are accepted or sometimes, for cell therapy, insurance companies actually have preferred centers they want patients to go to. That happens for stem cell transplant, that also happens for CAR T.

And a lot of that happens based on how the contracts are kind of designed or contracts are negotiated between an institution and an insurance company, et cetera, et cetera. I’ll be very frank, a lot of those details are way beyond my pay grade, so I won’t be able to go into the specifics of that. But what I can say is, a patient may not be able to…based on certain barriers, certain criteria, a patient may not be able to access CAR T-cell therapy at certain centers.

For example, let’s say there’s a patient in the Jackson metro area where I am, and they would like to come to Mayo Clinic, but their insurance and Mayo Clinic are not compatible. The patient may not be able to come for cell therapy, but yeah, that patient may be able to at least seek a consult. And through that consult, we’ll be able to then either connect the patient with a different center or give them details about, “hey, you know what, why don’t you consider going to X, Y, or Z and get the treatment over there?” I’ll be very frank, unlike the general thoughts around, well, everybody wants the patient to only come to them, I think those of us who are clinicians, academicians, educators, researchers, we want the right answer for every single patient. Whether that patient comes to me, one of my colleagues in a different institutions, one of my “competitors” in a different institution, it doesn’t matter, as long as the right treatment is coming to the patient.

So I think if a patient is not able to get to a treatment like CAR T, they need to understand, “What is the reason? Why am I not being able to get into it? Is there a barrier for distance, resources, insurance, education, just caregiver support? Why is it that I’m not getting it?” There should be enough buzz around CAR T that everybody should say, “Well, am I a candidate? If not, why not?” And once we find out what is the problem, that can be addressed. We are working quite hard in trying to get some of those accesses around the patients and different groups of patients, making them more equitable.

So for example, we do provide every CAR T-cell therapy patient with a social work consult. That social worker’s job is to figure out what are these barriers for that patient. But I understand that’s for the patients who have already come through the door to seeing us. But if a patient is not able to come to us because of some reason, as an institution, we are also making some efforts in trying to get more awareness and education to patients who are not coming to us, but are say, going to other institutions.

We are setting up webinars, going to patient support groups, talking, doing programs like this so that the information can be disseminated far and wide and anybody and everybody can benefit from it. So my activation tip for this question is, that from a patient’s standpoint and role, while institutions are trying their best to provide the care wherever they can, from a patient standpoint, understanding what might be the specific barriers in their case to get to CAR T and trying to get to an institution that has the resources to help overcome and mitigate some of those barriers would be very important.

Lisa Hatfield:

Thank you. That is why patients appreciate you because you’re willing to do what it takes to take care of your patients, even if it means sending them somewhere else. That is a characteristic of an excellent physician. 

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How Are Cultural and Language Barriers to CAR T Therapy Being Addressed?

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How Are Cultural and Language Barriers to CAR T Therapy Being Addressed? from Patient Empowerment Network on Vimeo.

How are CAR T therapy barriers of cultural and language nature being addressed? Expert Dr. Sikander Ailawadhi from Mayo Clinic discusses research study results on access barriers and ways to create solutions that address language and cultural issues.

[ACT]IVATION TIP

“…having a culturally sensitive discussion and a system that approaches the patients for complex treatments like CAR T or clinical trials. And personally, I’ve seen that it makes a big difference to the patient’s consideration of those treatment options.”

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How Can CAR T-Cell Therapy Be Explained to Patients and Families?

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 Reducing CAR T-Cell Therapy Barriers for Relapsed/Refractory Myeloma

Reducing CAR T-Cell Therapy Barriers for Relapsed/Refractory Myeloma

 Roadblocks for Black and Latinx Patients From CAR T Trial Access

Roadblocks for Black and Latinx Patients From CAR T Trial Access

Transcript:

Lisa Hatfield:

Dr. Ailawadhi, we know cultural or language barriers may hinder access to information about CAR T-cell therapy. How are you and your colleagues addressing this barrier?

Dr. Sikander Ailawadhi:

It’s very important to think about cultural or language barriers and how they may affect our way we deliver the care and the way the patients consume that healthcare. A few years ago we had done a study looking at just electronic medical record usage and how patients participate in their EMRs, for example. And we realized that for patients who are non-white, language barrier was a big issue because frankly, majority of our EMRs are English. They don’t provide a lot of Spanish or other language support.

Similarly, clinical trials and education material for CAR T, et cetera, they are very frequently in English. There is an increasing number of Spanish documents that are becoming available. So how we try to overcome these barriers, I think we have started, utilizing an approach in our institution where our research staff, we are trying to hire a diverse population.

There is data that based on studies, it has been very clearly shown before that, a patient is more likely to consider favorably a clinical trial or a treatment if it is being offered by someone who look and speak like them. So an African American patient is more likely to accept or consider a treatment, I would say, not even accept, but consider a treatment if it is being offered by an African American physician, an African American clinical research coordinator, et cetera.

While I’m not African American, I can’t change that, but we have African American, Hispanic, Asian clinical research coordinators in our teams, and we have noticed a clear difference in the patient’s understanding their ability to ask questions, their willingness to ask questions and clear out their barriers if it is given to them in a culturally sensitive, culturally appropriate manner.  So my activation tip for this question would be, having a culturally sensitive discussion and a system that approaches the patients for complex treatments like CAR T or clinical trials. And personally, I’ve seen that it makes a big difference to the patient’s consideration of those treatment options.

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