Tag Archive for: Dr. Krina Patel

What Are Myeloma Risk Factors for Veterans and First Responders?

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What Are Myeloma Risk Factors for Veterans and First Responders? from Patient Empowerment Network on Vimeo.

Veterans and first responders may come into contact with myeloma risk factors, but what are they? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses environmental risk factors for 9/11 first responders and veterans, average age of onset for different veteran racial groups, and proactive patient advice.

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“…if you notice that anything is off, you’re not feeling well, or the lab, something is wrong with your labs, make sure to mention that to your physicians, they can first diagnose the correct thing, if something is going on. And two, if you actually have a diagnosis of cancer, I think talking to your teams that there are probably resources out there to help with a couple of things, I think one, even financial resources.”

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Transcript:

Lisa Hatfield:

Dr. Patel, a lot of patients wonder what might have caused my myeloma, and there are some environmental factors that are known to have the association with myeloma, like Agent Orange exposure, and now we’re seeing an increased instance of myeloma and other blood cancers in the 9/11 first responders. For patients who might have concerns about this, do you have any suggestions or thoughts on that?

Dr. Krina Patel:

Yeah, I’ve actually quite a few patients that come up to me that were in previous wars or veterans, and the first thing I talk about is the 9/11 first responders. So people ask me if this they’re born with myeloma, that’s the number one question, and I say, you know, likely not, most people do not have genes that they were given by their parents, that causes myeloma.

All of us have different susceptibility to cancer based on how our immune system repairs itself, how our plasma cells repair themselves, the micro-environment, but it’s also our exposures, and we know that there’s certain exposures like Agent Orange, as well as those first responders that went in here in terms of epidemiology, in terms of the number of patients that ended up with myeloma at a younger age, a much younger age. They’re in their 50s, for the most part, that tells us that this was not something that those folks are going to get. This really was based on that exposure, and that’s the hard part of saying that something causes something.

I think we know with 9/11, the numbers were so high that this was a…listen, this is something wrong, that whatever they were exposed to during that process led to their plasma cells becoming myeloma at a much younger age, and it seems that a lot of them had more aggressive disease than the indolent slow-growing myeloma.

We see that a lot of patients get. The other big question I get is, How can we say that something caused this, and then again, it comes back to how many people are exposed and then how many people actually got that disease, and that’s why it becomes so hard. But I know a lot of my patients think about Roundup or different petrochemicals and things like that that they’ve been exposed to, and I know that the government and folks are looking into it because a lot of my patients are getting letters from us and things like that just to say, “Listen, I was exposed to this, could this have caused my myeloma?”

And again, the majority of patients are not exposed to things at that level that really tell us that that’s what caused their myeloma, but I do think that if you are exposed to something like Agent Orange or major petrochemical spill or something that is worthwhile noting at least, even though I most likely won’t be able to tell you it definitely caused the myeloma. We do know that there are environmental exposures that are more likely to lead to cancer, you know, we have these hot spots in the U.S. where especially those petrochemical companies are, where there’s a much higher level of just cancer diagnosis, not just myeloma up to cancer in general, compared to other areas where we don’t have those industrial companies existing.

Lisa Hatfield:

Do you happen to have any tips for patients who maybe were a part of 9/11 event or even veterans or first responders of any type, any tips for them in general?

Dr. Krina Patel:

Yeah, I think that the activations have here is that if you notice that anything is off, you’re not feeling well, or the lab, something is wrong with your labs, make sure to mention that to your physicians, they can first diagnose the correct thing, if something is going on. And two, if you actually have a diagnosis of cancer, I think talking to your teams that there are probably resources out there to help with a couple of things, I think one, even financial resources.

When stuff like this happens, usually there are some financial resources that pop up, and two, the mental aspect of this. You got this while you’re doing something you’re supposed to be doing and helping others, and really finding patient groups which are out there as well, so that you get the resources for just the ability to talk to someone about what happened and being able to go through that process as well.

Lisa Hatfield:

Dr. Patel, are there any notable trends or patterns of the presentation and progression of myeloma and other blood cancers in veterans and first responders that differ from civilians?

Dr. Krina Patel:

Yeah, that’s a great question. I honestly don’t know if there’s been anything published that shows a difference, I tend to see my veterans are a little bit younger in general, average age for myeloma, 70 for Caucasian patients, it’s 65 for Hispanic patients and 66 for African American patients, right? So a lot of my veteran patients have been in their 50s, just a little bit younger than what I’ve seen with most other patients, and then in terms of patterns, not necessarily.

We think, oh, is it more aggressive? Is it not. I do have patients with aggressive disease, but I have patients that come in with MGUS or smoldering disease that eventually turns into myeloma isn’t necessarily high risk or aggressive, but again, I don’t know any data that’s out there that’s published, I think that would be worthwhile. But I will say my patients tend to be on the younger age.

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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.

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“…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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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.

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“…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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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.

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

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

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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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See More from [ACT]IVATED CAR T

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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Dr. Krina Patel: Why Is It Important for You to Empower Patients?

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Dr. Krina Patel: Why Is It Important for You to Empower Patients? from Patient Empowerment Network on Vimeo.

Why is it important to empower patients in their care? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses her approaches and how she engages with her patients through treatment, care, and survivorship.

See More from Empowering Providers to Empower Patients (EPEP)

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Transcript:

Dr. Krina Patel:

So I think in myeloma, where our patients for the most part are not cured, they’re incurable and for the most part are on therapy lifelong. I think it’s really important that they have a community to go to, including their caregivers. There’s a lot of caregiver burnout that happens, patients, when they’re doing well or well, but when they relapse, it can be pretty dramatic and kind of take away everything again. And every time a patient’s relapsing, sometimes it feels hopeless.

And I think with all the therapies we have out there, this embarrassment of riches as we myeloma doctors like to say, we have to be able to get them through to have access to these drugs at the right time, make sure we decrease toxicity. But it’s a lot of information.

And I think for our patients, no matter how much time we spend with them, it’s just, it’s overwhelming. And I think it is for a lot of my colleagues who don’t just do myeloma all the time. I mean, it’s overwhelming for me half the time when I’m trying to see my patients and figuring out which is the next therapy. And so I really, at the first visit, talk to my patients about patient advocacy groups that are out there. And I even give them websites to go to.

At MD Anderson we’re trying to make videos for our patients so that while they’re waiting in the waiting rooms, they’ll have access to those, specifically, for CAR-T therapy and bispecifics. I think those are such great novel therapies, but they’re also high maintenance as I like to call them that there’s a lot of supportive care that’s needed for infection prophylaxis to make sure they don’t get secondary cancers, right?

All these complications that can happen, neurotoxicity, etcetera. And thankfully, for the most part, our patients do really well and they can get through it. But for those patients who end up with that, it’s really important they have this information, so they know when to contact us. And I think for my colleagues as well, we’re trying really hard to make sure we have better communication, for my patients that are in the community coming in for CAR T or for bispecific therapy, then going back to their doctors, their community doctors for the rest of their care.

So we have letters, that we come up with that we give to the patient as well as send to their doctor. We have phone numbers they can call that even if they’re back home, and they need to get ahold of someone that, they have a lifeline to say, I don’t know what to do. This is happening. And I think, it’s really important again for the patients and their caregivers to really understand, this is a lifelong journey, right?

This is not something that you’re just going to get a few cycles of treatment and then you go to survivorship clinic. And then hopefully we never have to treat again. And that this myeloma as of right now is still a continuous therapy and it could be, long periods of time between therapies. Or you might go on maintenance, for a long period of time before you need your next line of therapy, but this is a lifelong therapy that we’re going to have to do with, with everybody involved.

And I think, again, I can’t see every patient out there and most myeloma specialists can’t, but we’re happy to be a part of the team. And so really, when we can have access to things that the community might not, or be able to help in terms of, what combination is the best for this patient, and what dose reductions should we do for this specific patient?

Those are the things we would love to help our community doctors with to make sure outcomes for all our patients, those who are near us, but those who are also physically not close to us that we can still be able to help to make sure that they have the best efficacy, but also the best quality of life with this disease.

Understanding Myeloma Therapy Targets BCMA and GPRC5D

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Understanding Myeloma Therapy Targets BCMA and GPRC5D from Patient Empowerment Network on Vimeo.

What are myeloma targets, and how do they impact the effectiveness of therapy? Dr. Krina Patel explains how treatments like bispecific antibodies and CAR T-cell therapy are using myeloma targets such as BCMA (B-cell maturation antigen) and GPRC5D (G protein-coupled receptor 5D) to kill myeloma cells. 

Dr. Krina Patel is an Associate Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, Texas. Dr. Patel is involved in research and cares for patients with multiple myeloma.

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Transcript:

Katherine:

We know that the currently approved bispecific antibody therapies target BCMA and GPRC5D. What are these targets precisely and how do they impact the effectiveness of the treatment? 

Dr. Krina Patel:

No, it’s a great question.  

And, again, so BCMA we’ve had for a little bit longer.  

We’ve known about it for a little bit longer, B cell maturation antigen, which definitely we’ve used as much as we can. So, we’ve had CAR Ts for it. We’ve had bispecifics for it. We’ve had antibody drug conjugates that we’ve attached to it. 

So, it’s a really good target that is mostly just on myeloma cells and on very few other cells in the body, for the most part, which is why it makes such a great target. The side effects really should happen only specifically against the myeloma; so, less side effects in terms of toxicity. That’s not 100 percent the case.  

BCMA is in some other tissues, like maybe the nerves, and that’s why maybe we see this toxicity sometimes, potentially in the GI system. Some patients can have it in other places. If you have myeloma in, let’s say, areas like the kidney. If you have a plasmacytoma, it can go to the kidney, things like that.  

But again, for the most part, mostly on myeloma. And what’s really important about these targets is, once you get a treatment for it, what happens to that target. So, that’s a little bit different between these two targets. So, BCMA is a part of the proliferation of myeloma cells. So, it actually helps the myeloma cell survive. And so, the myeloma cells really want that BCMA on there. Now, for CAR T, for the most part, we don’t see people losing BCMA. We might see it go down in the myeloma cells that are left. For some patients, the expression can go down. But for the most part, we’ll see it come back up a few months later if the myeloma’s coming back.  

The way that resistance happens with BCMA is that, when people are on bispecifics, the other treatment, we can sometimes see the BCMA get mutated. And then, maybe the other therapies we have won’t go after it any more.  

So, again, it’s not common, but that’s sorta something we look at when we talk about sequencing therapy or which therapy should we use first. Then, GPRC5D’s a little different.  

So, again, mostly just on myeloma cells. But here, we do know it’s on something called epithelial cells, which is skin, nails, tongue. And that’s why some of the side effects that we see, especially with the bispecific that’s a standard of care already, talquetamab, is skin and nail changes. So, people can get sloughing of their hands and nails; that can get disrupted. And then, taste. People can actually have some significant taste loss, to the point that they can have weight loss from it.  

So, this is why that part is so important that if we have patients with these side effects, we need to hold the drug or decrease it; so, make sure we can turn those around. And then, the way GPRC5D is we think that it’s a little bit more likely that you can lose it once you get a treatment with GPRC5D that the myeloma can actually learn how to shed the antigen.  

So, again, this really becomes important when we talk about combination and sequencing of all these different therapies we have and what’s the best way to do it so that patients can have the best response and the longest response.

How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

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How Is CAR T-Cell Therapy Research Advancing Myeloma Care? from Patient Empowerment Network on Vimeo.

What progress is being made in furthering advancing CAR T-cell therapy for myeloma? Dr. Krina Patel discusses the manufacturing process for CAR T-cells, research updates for manufacturing CAR T-cells faster, and the benefits of bridging therapy for some patients. 

Dr. Krina Patel is an Associate Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, Texas. Dr. Patel is involved in research and cares for patients with multiple myeloma.

Related Resources:

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

 Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment

Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment?

 Advances in Managing CAR T-Cell Therapy Side Effects

Advances in Managing CAR T-Cell Therapy Side Effects

Transcript:

Katherine:

Are there other advances in CAR T-cell therapy that patients should know about?  

Dr. Krina Patel:

Yeah, so I think part of the issue right now is manufacturing and how long it takes for patients to get those cells. So, we use it to our advantage in the sense that earlier-line patients will have bridging therapy that we can give them while we’ve collected their cells and they’re being made; it takes are 4 to 6 weeks, or even eight weeks sometimes that we can give them a therapy that can knock their myeloma down before they get the CAR T.  

And again, this is really important that we have options available. So, in fifth-line we don’t have very many options available. So, a lot of my patients, we really are just struggling to keep the myeloma controlled, try to bring it down before they get their CAR T. We’re hoping that that CAR T comes in any day.  

When it goes earlier, I’m hopeful that now we’ll have options to actually bridge patients better because we’ll have more therapies they haven’t had. And the reason that bridging is so important is it really does decrease toxicity, some of the serious toxicity with see with CAR T; significantly decreases it.

And the efficacy. We see patients will do much better for longer if they have less myeloma going in than lot of myeloma going in. And so, again, I think because of that time, if we could get those cells earlier, that just makes it so much easier for all our patients to make sure that they’re able to get the cells. So, there’s quite a few different trials looking at fast CAR T production.  

And so, there’s the PH383, I think. I can’t remember the number exactly. But this is one of the studies that was happening at Dana-Farber, and Dr. Sperling has presented couple time. The cells are made within just 24, 48 hours. And then, they actually go in and as they’re killing the myeloma, they grow.  

So, they grow inside the body which is really, really, I think, a interesting way to develop CAR Ts for the future, make it more applicable and accessible. And then, there’s other companies in China. There’s the FasT CAR, which is a CD-19 plus BCMA, so two targets. But again, they can make their CAR Ts within a week.

And in the end, you have to still do quality checks for the FDA, which still take two weeks. So, it always will still be a few weeks, but still, the faster you can make those CAR’s, the more likely our patients are gonna be able to get it. And then, I think the combination studies. Again, there’s gonna be studies with different targets. So, there’s two CAR Ts, again, GPRC5D, that are going to be tested in the U.S.  

A phase two study. And then, also another phase one study. And then, the phase two study, that GPRC5D CAR T is going to have combination studies coming out very, very soon. Actually, it’s already open in some places, and more places that are opening soon.  

So, I think, yes, a lot’s going on again with new antigens and combinations. 

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

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How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials? from Patient Empowerment Network on Vimeo.

How can patients learn more about joining myeloma CAR T-cell therapy clinical trials? Dr. Krina Patel shares advice for identify and accessing these trials, noting that seeking care with a myeloma specialist can be most helpful. 

Dr. Krina Patel is an Associate Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, Texas. Dr. Patel is involved in research and cares for patients with multiple myeloma.

Related Resources:

Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment

Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment?

 How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

 Understanding Myeloma Therapy Targets BCMA and GPRC5D

Understanding Myeloma Therapy Targets BCMA and GPRC5D

Transcript:

Katherine:

How can patients find and access clinical trials that are looking at CAR T-cell as an earlier line of therapy?  

Dr. Krina Patel:

That’s a great question. So, I think going to any place that is myeloma specific. So, basically a big center that has doctors that are doing myeloma research, they will be able to definitely get you into places that have some of these trials. But clinicaltrials.gov is one other place. It’s really hard. I will tell you that, if I wasn’t a physician or in medicine, I don’t think I would learn, I would be able to navigate it very well.  

And so, really either through your doctor and having them look this up for you, or going to patient groups. So, again, a lot of my patients are part of different patient groups where people will say, “Well, this is a trial that I was” or “This is a trial that my doctor told me about.” And then, asking. So, that’s the other big thing is constantly asking your doctor “What are my other options?” getting second opinions from myeloma experts, and then just paying attention to some of these resources that you have available. Right now, there are gonna be more clinical trials for earlier-line therapies and first-line with both cilta-cel and ide-cel.  

There’s going to be clinical trials with new products: ddBCMA CAR T, that is likely gonna come out soon for earlier-line therapies. And so, there’s a lot happening, and so there might be different clinical trials in different places. But I think the fact that all this is going on at once is really important for our patients to know about. 

Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment?

/in , , , , , , , /by

Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment? from Patient Empowerment Network on Vimeo.

Is there an opportunity for myeloma patients to gain access to CAR T-cell therapy sooner? Dr. Krina Patel discusses the results of clinical studies for CAR T-cell therapy and the potential for patients receiving the treatment earlier in their myeloma journey.

Dr. Krina Patel is an Associate Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, Texas. Dr. Patel is involved in research and cares for patients with multiple myeloma.

Related Resources:

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

 How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

 Advances in Managing CAR T-Cell Therapy Side Effects

Advances in Managing CAR T-Cell Therapy Side Effects

Transcript:

Katherine:

Dr. Patel, current CAR T-cell therapy is FDA approved for patients who have had several lines of treatment. 

But we know that there are a number of trials that are exploring this treatment in earlier lines. So, what is the progress on these trials? 

Dr. Krina Patel:

Yeah. So, I think we have two major ones that have already been done and we’ve heard the results from. So, CARTITUDE-4 was for cilta-cel in second to fourth-line; so, patients who have relapsed once, all the way up to three times.  

And then, KarMMa-3, which is ide-cel, which was one line later. So, that was third-line to fifth-lines; so, relapsed twice to four times. So, little bit different patient populations in the two trials. The trials were different in that patients had different therapies before too.  

But both were positive studies which was what was really exciting. So, in CARTITUDE-4 patients were randomized, meaning they got either the CAR T or they got a standard of care option. And the CAR T won by a lot. This was, we call, hazard ratios.  

But basically, the amount of different of patients surviving when they got CAR T without myeloma versus the standard of care was one of the biggest differences we’ve ever seen in a clinical trial for multiple myeloma. So, it’s – 

Katherine:

Wow. 

Dr. Krina Patel:

– something really pretty amazing. And then, KarMMa-3, that trial, same thing. There’s a huge difference in the patients who got CAR T versus the standard of care. The standard of care options were different in the two trials for the most part. So, again, different patient populations and different standard of care options, but the other big thing that the KarMMa-3 study did was they allowed for patients who are on the standard of care that, once they were relapsing, they could get the CAR T.  

And so, because we have this crossover the big controversial thing that came up was, “Well, patients aren’t necessarily living longer by getting CAR T earlier. As long as they get CAR T they do really well.” And so, that is why there was a big meeting with the FDA what we call the ODAC meeting.  

So, they had both companies present their trials to the FDA and to this advisory board that they had called ODAC, and thankfully it was positive. So, both studies were positive in terms of the advisory board saying that they agreed these should be moved up forward.  

So, now we’re just waiting and hoping the FDA approves them so that we can actually give it to patients. I think the biggest reason is access. So, we know that when patients are fifth-line, which is when it’s approved now, not everybody makes it to fifth-line. It’s really hard to get through all these therapies and then still be healthy enough to do this versus if it’s approved in second and third-line, that just means so many people can actually get these therapies and available to them.  

And the other big thing is the quality-of-life piece for CAR T. It’s been such a big difference when patients get a break from therapy for a year or two years or longer compared to being on continuous therapy. And so, both studies have had quality of life studies come out as well showing that difference between the standard of care versus the CAR T.