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Clinical

Andre H. Goy, MD; Sandra M. Swain, MD, FACP, FASCO Associate Dean for Research; Carolina Bernabe Ramirez, MD; Jonathan E. Rosenberg, MD; David H. Vesole, MD, PhD, FACP Director, Myeloma Program; Isabel Preeshagul, DO, MBS  
 

Community Practice Connections™: 5th Annual Precision Medicine Symposium – An Illustrated Tumor Board

Karen M. Winkfield, MD, PhD; Narjust Florez, MD, FASCO; Gilberto de Lima Lopes Junior, MD, MBA, FASCO; Coral Olazagasti, MD; Vonetta M. Williams, MD, PhD

 Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care

Ibrahim N. Muhsen, MD, evaluated the efficacy of brexu-cel in adult patients with central nervous system involvement in relapsed/refractory B-cell acute lymphoblastic leukemia.

Brexu-cel Achieves Strong CNS and Systemic Responses in Adult B-ALL Patients

A pivotal phase 2 trial of WU-CART-007, an anti-CD7 CAR T-cell therapy for relapsed/refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma treatment, will begin in 2025.

Study of Novel Off-the-Shelf CAR-T in T-ALL/LBL Launching in 2025

Real-World CAR T-Cell Therapy Outcomes in DLBCL Reveal Challenges and Disparities

The FDA has lifted clinical holds on trials of zevor-cel, satri-cel, and CT071, and trials will now resume in the US.

FDA Lifts Clinical Holds Placed on 3 CAR T-cell Therapy Trials

A single infusion of the autologous GPRC5D-targeted CAR T-cell therapy BMS-986393 led to high response rates in patients with relapsed/refractory multiple myeloma who received between 1 and 3 prior lines of therapy.

Single CAR-T Infusion Shows Deep and Durable Responses in Relapsed Myeloma

Exploring the Evolving Role of CAR T-Cell Therapies in Multiple Myeloma

Santhosh K. Sadashiv, MD, a hematologist with Allegheny Health Network and West Penn Hospital, and assistant professor at Drexel University School of Medicine, discusses the role of chimeric antigen receptor (CAR) T-cell therapy in patients with multiple myeloma.

Specifically, Sadashiv highlights what particular factors he considers most critical when selecting patients for CAR T-cell therapy. He also discusses some of the new indications for CAR T-cell therapy in multiple myeloma.

 It has changed a bit. Previously, CAR T was earlier to come on to the market for treatment of patients. So, we have pushed certain age limits, but this is much [more] well-tolerated compared [with] the autologous transplant. So, even [for] patients in their late 70's, and if they are doing well [with a] relatively good performance status, age is definitely not a barrier for these patients. But if they are really in their octogenarian status, then we would love to use, or prefer to use, bispecifics, which [are] much more tolerable.

But even elderly patients can be considered for CAR T if they are deemed to be in a good performance status. But generally, younger patients or [those who are] otherwise fit with not too many medical comorbidities, would be an ideal candidate [when we are] considering CAR T treatment options.

Previously, when they were initially introduced, they were introduced at the fourth- or fifth-line of therapy, again, relapsed to multiple lines of treatment. And that is where these treatments were initially approved, both [idecabtagene vicleucel (Abecma)] and [ciltacabtagene autoleucel (Carvykti)]. These are the 2 drugs that are available at present in the market. However, there were more recent clinical trials that were conducted, mainly KarMMa-3 [NCT03651128] for idecabtagene and CARTITUDE-4 [NCT04181827] for ciltacabtagene. The idecabtagene was earlier, after 2 lines of therapy, whereas CARTITUDE-4 looked at ciltacabtagene after 1 line of therapy.

Both of these studies show significant progression-free survival in earlier lines of therapy compared [with] the standard-of-care. So, this led to the approval of these drugs, for the ciltacabtagene after the first-line of therapy, and for idecabtagene after the second-line of therapy. So, they have definitely moved from the space of fourth- or fifth-line of treatment to now second-line treatment after they have failed either their transplant or if they are initially being a non-transplant candidate for whatever reason after they fail their first-line of treatment, they cannot be considered for CAR T treatments.

Videos

Santhosh K. Sadashiv, MD, discusses the role of chimeric antigen receptor T-cell therapy in patients with multiple myeloma.


News

Improving Patient Access to CAR T-Cell Therapy

A recent study examined the real-world experience of patients receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapies for B-cell non-Hodgkin lymphoma. The primary focus was on the occurrence and duration of side effects like cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

The results showed that while the incidence and duration of these adverse effects varied between different CAR T products, most severe reactions occurred within the first 2 weeks after infusion. Importantly, new-onset CRS was extremely rare after 2 weeks, and only 1 case of new-onset ICANS was reported in the third week. These findings have significant implications for patients who have difficulty accessing CAR T due to practical or financial constraints due to the follow-up time required after the treatment. 

The study also analyzed the causes of nonrelapse mortality, finding that ICANS was a significant factor in the early period, while infections were more common later on. These findings suggest that a shorter monitoring period might be possible for many patients, potentially reducing the financial burden and inconvenience associated with prolonged hospital stays.

 associate professor of hematologic malignancies and cellular therapeutics at the University of Kansas Medical Center, discusses issues with access to CAR T-cell therapy that the study explored. 

A lot of patients are not able to get CAR T because because they don't have ability to stay for weeks. They don't have maybe the ability to have a caregiver for four weeks. There's there's some nuances there. So this is hopefully, if there's a change made based on these findings, this might help many patients. 

I do think that in general, the closer that CAR T can be to an off the shelf medication, the less the physical burden, the less the financial burden, right, on the patient. That, in general, will increase the utilization of CAR T. So for example, there's a whole process where they have to come get get evaluation get what we call leukapheresis. They get collection done and waiting processes for 2 weeks. And so I wonder if some of those processes can be streamlined, which would be more on the scientific end, or where if we have allogeneic products, which are off-the-shelf products that might make it easier. If we have products with even more safety profile where the monitoring period could be even even more amenable where the patients can go back to the community earlier. Those are things I'm looking forward to.

CAR T-cell therapies have shown remarkable efficacy in treating hematologic malignancies but carry risks. Current guidelines require close patient monitoring for 4 weeks post-treatment. A study of 475 patients found that serious side effects like cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are extremely rare after 2 weeks. While infections caused mortality after the first month, no new cases of CRS occurred after 2 weeks and only 1 case of ICANS developed in the third week. These findings suggest that a more flexible monitoring period beyond 14 days may be safe and could potentially reduce patient burden and healthcare costs. 

Here, Nausheen Ahmed, MD, associate professor of hematologic malignancies and cellular therapeutics at the University of Kansas Medical Center, and primary author of the study, discusses these findings and implications. 

The main reason that a patient should be near the near the treatment center is this if there's a high risk of some very, you know, very dangerous side effects, like CRS and neurotoxicity. So I do think that the first two weeks, they should they should be really monitored in a place where there's an infrastructure where they can get into, they can care the treatment, like promptly. And and there's intensives. And everyone that's that's very focused on on on car T. But after two weeks, I don't think that there's you know, I think that it's the monitoring should not There's no magical four weeks, right? The monitoring and the because there's still there's still morbidity, there's still there's still mortality from infections, even up to the 90 day mark. 

So I think it has to be a continuum. At some point, whenever the patient's stable enough, they should be able when when I said I emphasize stable enough, I emphasize flexible monitoring period, or whenever it is determined between the treatment center and the referring oncologist that the patient is now stable, to be back at the infrastructure in the community. That's when the transition would be ideal. And that could be that could be at any time point. And it would, it would depend on what the infrastructure is locally. And really, the focus at that point should be monitoring for infections. Being able to communicate directly with the treatment center having a pathway for the patient to be seen promptly at a local facility and may be transferred to the treatment center if needed, because there still can be risks. So the focus should be on collaboration and understanding. Understanding what are the what are the reasons for mortality after the two weeks, which is infections primarily.

Nausheen Ahmed, MD, discusses the guidelines for monitoring patients after receiving CAR T-cell therapy. 

Optimizing Patient Monitoring CAR T Treatment

video on Binod Dhakal on approval of cilta-cel after CARTITUDE-4 

Patient Selection Factors for Earlier Use of CAR T-Cell Therapy

Binod Dhakal, MD, MS, assistant professor of medicine in the Division of Hematology and Oncology at the Medical College of Wisconsin, discusses selecting patients for chimeric antigen receptor (CAR) T-cell therapy by considering each patient’s condition and logistics.

Ciltacabtagene autoleucel (cilta-cel; Carvytki), a CAR T-cell therapy, was approved for patients with relapsed/refractory multiple myeloma who have been treated with at least 1 prior line of therapy based on the CARTITUDE-4 study (NCT04181827), whereas it was previously approved for patients after 5 lines. Before CAR T-cell therapy can be initiated, T cell collection and lymphodepletion, potentially causing delays. After treatment, patients still need to be monitored for CAR T-cell–related toxicities including cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS) afterward.

Dhakal says that in the late relapse setting, CAR T-cell therapy is the only highly effective treatment available to patients, and delays can harm patients. However, in the earlier setting opened by this approval, patients still have other options and can afford to wait before initiating cilta-cel.

He added that in CARTITUDE-4, CAR T-cell–related adverse events (AEs) were lower in occurrence and severity than when it was investigated in more heavily pretreated patients in CARTITUDE-1 (NCT03548207). With this in mind, he suggested considering the patient’s performance status, the time of relapse and number of prior therapies, and caregiver support to ensure patients can be monitored after treatment easily. Although Dhakal believes most patients could benefit, not all meet these criteria. Nevertheless, making cilta-cel available earlier in the course of treatment can benefit patients who are eligible for CAR T-cell therapy.

Once you get the CAR [T-cell therapy], there are definitely some short-term and long-term, what we call CAR [T-cell therapy]–related toxicities that we have to monitor. So I think there is a requirement to monitor afterwards as well. It's not that when you get the CAR T-cell therapy you're done. So I think when you choose a patient...you have to think about...all these aspects. For example, when the patients are in late relapses, I think what happens is they don't have a lot of options. And so when you think of the CAR [T-cell therapy]...that is the one treatment that is only effective treatment that is available now. In the second line and beyond, I think the good thing is that they are still early on, they could still try other options. And so there is an opportunity for the patient to wait for about a couple of months easily while getting the CAR [T-cell therapy] afterwards. So I mean to say that the urgency to get the CAR [T-cell therapy] is not that immediate. In the majority of the patients, they can wait.

What we also saw in CARTITUDE-4 is that if you give it, CAR [T-cell therapy]–related AEs, when you compare to CARTITUDE-1, were lower, like CRS, ICANS, the other related neurotoxicities, etc. Both rates and severity were lower. So that means if you're giving the CAR T at an earlier line, which...is dictated by the disease burden in that setting, I think the CAR [T-cell therapy]–related AEs can go down. So I think when you offer this treatment, you have to make sure how the patient's disease is, how they are relapsing, what is the patient's overall condition, the performance status, and then at the same time…it's important to have that monitoring from the caregiver as well after they receive the CAR [T-cell therapy]. All these things will help in deciding the right patients to get this therapy. Ideally, I would like to give it to all patients, but not all patients will fit the criteria. But moving this earlier than later, I think the majority the patients will be able to get this [rather] than when they are at the later stages.

Transcription created with AI and edited for clarity.

Binod Dhakal, MD, MS, discusses selecting patients for chimeric antigen receptor T-cell therapy by considering each patient’s condition and logistics. 

Secondary Malignancies After CAR T: How Big is the Risk?

Binod Dhakal, MD, MS, assistant professor of medicine in the Division of Hematology and Oncology at the Medical College of Wisconsin, discusses the potential risk of secondary cancers like lymphoma and leukemia sometimes seen with chimeric antigen receptor (CAR) T-cell therapies, including ciltacabtagene autoleucel (cilta-cel; Carvykti).

There are case reports of the secondary T-cell lymphoma, and then some cases of secondary [acute myeloid leukemia (AML)] and [myelodysplastic syndrome (MDS)] reported with cilta-cel in trials, as well as with the other CAR T products. I think this is a risk that we cannot just ignore. We definitely have to be vigilant about it.

Now, when we look at the overall risk, what is the overall risk in this setting, I think the data is still being followed, and we will know more as you go with the time. But I think that the data from CARTITUDE-4 [NCT04181827], and even the KarMMa-3 study [NCT03361748], which is a border, randomized study where they are comparing the CAR T with the standard of care, I think are gonna give more insights as we follow these patients because the number of cases of secondary malignancies, particularly the secondary MDS and AML seen in the CARTITUDE-1 patient population, is a little bit difficult to interpret the actual risk of this treatment because that is a single-arm study with no control arm and a heavily treated patient population. But I think the data from both CARTITUDE-4 and KarMMa-3, where this is being used in an early line that is less heavily pretreated than the CARTITUDE-1 [NCT03548207] patient population or KARMMA patient population, and with the control arm, I think once we follow these patients longer and see the cases of both MDS, AML, and also the secondary cancers, including T-cell lymphoma, this is going to give more insights on the actual risk of this treatment.

Right now, I think, yes, it is a concern. We have to be vigilant about it, we have to educate the patients, we are aware of it. But in terms of offering the treatment to the patients, I would say that the benefits outweigh the risks, and it still has a better impact and better outcome for these patients.

Binod Dhakal, MD, MS, discusses the potential risk of secondary cancers like lymphoma and leukemia sometimes seen with chimeric antigen receptor T-cell therapies.

A multitude of studies on chimeric antigen receptor (CAR) T cell therapies were presented at the 

2024 Transplantation and Cellular Therapy Tandem Meetings

several of which revolved around the use of CAR T in multiple myeloma. These included updates from the CARTITUDE-1 (NCT03548207) and CARTITUDE-2 (NCT04133636) studies investigating ciltacabtagene autoleucel (cilta-cel; Carvykti). 

Rahul Banerjee, MD, assistant professor in the clinical research division at Fred Hutch, delved into the research from these studies presented at the meeting. 

The other I think really interesting update was twofold. One was that there was a poster yesterday from Dr. Lim from Mayo Clinic and colleagues are the CARTITUDE-1 study. So ciltacabtagene autoleucel, which is a CAR T therapy in myeloma, the original US study of that product is now years out, 97 patients, and the median PFS we know is coming up on 3 years. Interestingly, they were able to really look at components of the CAR T infusion and very easily predict who is going to have a durable response and who wasn't. For example, how many effector CD8 cells or what we'll call killer T cells or cytotoxic T cells were in the bag vs CD4 cells vs for example, T reg cells or regulatory T cells. Those are cells that typically dampen the immune system and can also turn into CAR T regs, if that makes sense. 

And the more they had of those, the worse—Dr. Lim presented that poster yesterday, and she's the walking behind me right now. So the more of the CAR T cells, the CAR T regs that patients had, the worst they did. And that's really interesting. No one I think is at a position yet where we would try to prognosticate based on the composition of someone's bag, or try to triage our product to give someone based on someone's bag. But it was really interesting to say that, look, for patients where you know that based on the composition of T cells in CAR T, they're not going to do that, well, can we modify the T cells before they had a undergo collection or so forth? So that's 1 thing. 

The other interesting product also from the CARTITUDE series of trials was CARTITUDE-2 cohort B. That was an oral abstract yesterday, Dr. Helen Gaston and colleagues from Roswell Park, and they presented 2 cohorts. But the 1 that I think is most interesting is cohort B, is what we call functional high-risk myeloma. So these are patients where the myeloma comes back much earlier than expected, often a year after starting frontline therapy with with a transplant. Those are the patients who terrify me. They terrify all of us because they don't always have high-risk cytogenetics, meaning that we don't always know is this going to happen? This is a patient who they're in remission, they undergo transplant and all of a sudden, 3 months later, the myeloma is back well ahead of when it should, and that's really unfortunate. So I think here, they use cilta-cel in those particular patients CAR T and they found that the PFS in those patients, hard to say because we don't have enough follow up with at least 2 years, probably going to come up on 3 years similar to CARTITUDE-1. 

 And that may suggest to us, and KARMMA has done something similar with ide-cel as well, that in these functional high-risk patients who have early relapse, unplanned relapse much earlier than planned, their prognosis directly has been terrible, nothing works for them, possibly CAR T may be the solution we're looking for to kind of just level the playing field. And whatever protoplasm, whatever mix of bad tumor biology and bad immune surveillance unfortunately leads a patient to have a relapse earlier than expected. CAR T may be our ticket to kind of get them out of that situation.

Rahul Banerjee, MD, discusses new frontiers in the treatment of multiple myeloma with CAR T-cell therapy. 

Conference News

Banerjee Discusses Emerging Research for CAR T in Multiple Myeloma

video of Dr Khan discussing ide-cel and the KarMMa-3 trial

Updated Trial and Real-World Data Show Benefit of Ide-Cel for Multiple Myeloma

Abdullah M. Khan, MBBS, assistant professor in the division of hematology at The Ohio State University Comprehensive Cancer Center – The James, discusses the recent updates to data on the use of idecabtagene vicleucel (ide-cel; Abecma) in patients with relapsed/refractory multiple myeloma.

Updated data from the pivotal phase 3 KarMMa-3 trial (NCT03651128), which led to the approval of this chimeric antigen receptor T-cell therapy, were reported at the 2023 American Society of Hematology Annual Meeting & Exposition. At a follow-up of 30.9 months, investigators reported interim overall survival (OS) data, showing that the median OS was 41.4 months with ide-cel vs 37.9 months in the standard therapy group.

Additionally, Khan noted that real-world evidence with ide-cel was reported in the 

 in 2023, supporting its use in patients who do not necessarily match the stringent patient eligibility requirements of a clinical trial. For the 159 patients who received ide-cel, the best overall response rate was 84% and median progression-free survival (PFS) was 8.5 months (95% CI, 6.5-not reached), whereas median OS was 12.5 months (95% CI, 11.3-not reached).

According to Khan, these are both promising sources of data showing the benefit of ide-cel including in patients with comorbidities who are treated with CAR T-cell therapy in the real world.

 I wanted to give a little bit of updated data from the ASH 2023 conference. We actually have survival data for the KarMMa-3 trial with a longer follow-up of about 31 months. What they were able to show was the median OS in the ide-cel group was 41.4 months vs 37.9 months in the standard [therapy] group.

 There was also recent publication talking about ide-cel in the real world. Real world means that inclusion and exclusion criteria that are pretty stringent in trial design, we're applying less of those rules toward the patients we see in our clinic. And in a recent publication in JCO in 2023, in 159 patients, what they showed was response rates were also very impressive, about 84%. …In these less ideal patients…in terms of trial candidacy, median PFS was 8.5 months, and the median OS was 12.5 months. Again, very promising data, not just in the trial, but also real-world data.

Abdullah M. Khan, MBBS, discusses the recent updates to data on the use of idecabtagene vicleucel in patients with relapsed/refractory multiple myeloma. 

Ibrahim N. Muhsen, MD, a hematology and medical oncology fellow at Baylor College of Medicine, discusses the findings and key takeaways from his presentation

Efficacy and Safety: Brexu-cel's Impact on CNS Response in B-ALL

Ibrahim N. Muhsen, MD, a hematology and medical oncology fellow at Baylor College of Medicine, discusses the findings and key takeaways from his presentation looking at central nervous system (CNS) responses to brexucabtagene autoleucel (brexu-cel; Tecartus) in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) entering chimeric antigen receptor (CAR) T-cell therapy with active CNS involvement.1

, brexu-cel led to notable efficacy in achieving high rates of CNS remission in patients with relapsed/refractory B-ALL.

Specifically looking at safety, cytokine release syndrome (CRS) of any grade was observed in 73.5% (n = 25) of patients. Grade 3/4 CRS was seen in 3% (n = 1) of patients. The median time to CRS onset was 5 days (range, 1-10), and these adverse events (AEs) lasted for a median of 4 days (range, 1-10). Notably, 26.5% (n = 9) of patients did not have a CRS event.

Any-grade immune effector cell-associate neurotoxicity syndrome (ICANS) was seen in 76.6% (n = 23) of patients. This included grade 3/4 ICANs in 35.3% (n = 12). The median time to ICANS onset was 7 days (range, 3-15), and the median duration of this toxicity was 3 days (range, 1-30).

Moreover, CRS that was grade 3 or 4 affected 3% (n = 1/34) of patients with CNS disease, 12% (n = 19/155) of patients without CNS disease whose data were included in the Real World Outcomes Collaborative for CAR T in ALL (ROCCA) consortium, and 24% (n = 13/55) of patients in the ZUMA-3 trial. Rates of grade 3/4 ICANS were 35.3% (n = 12/34), 30% (n = 47/155), and 24% (n = 13/55) in each respective group.

Overall, findings from the study showed that treating adult patients with CNS B-ALL with central nervous syste is feasible.

 When it comes to the safety of brexu-cel, our patient population that has a very low rate of high-grade CRS, we actually had only 1 patient that had grade 3 to 4 CRS. On the other hand, when it comes to ICANs, we had a higher number of patients who had grade 3 to 4 ICANs of 35%. However, when we compared the numbers to the number of patients who develop the grade 3 to 4 ICANs in the ROCCA consortium database without CNS involvement, the numbers were similar.

 Additionally, when it comes to the efficacy of the CAR T cells, we did see that our patients had a very high CNS response rate. We had 22 patients who showed response out of 25 who were evaluated, which is almost more than 85% of patients who achieved CNS1 status or no CNS disease after the CAR T-cell therapy. Our findings are very encouraging for the use of CAR T-cell therapy in patients who have CNS B-ALL. However, more studies are needed to confirm these results.

Ibrahim N. Muhsen, MD, discusses the findings and key takeaways from his presentation given at the 2024 Tandem Meeting.


Matthew J. Frigault, MD, MS, discussed what a community oncologist should know about the FDA investigation of chimeric antigen receptor (CAR) T-cell therapies.

CAR T Benefits in Cancer Outweigh Potential Risk of Secondary Malignancies

Matthew J. Frigault, MD, MS, discussed what a community oncologist should know about the ongoing FDA investigation of chimeric antigen receptor T-cell therapies.


CAR T-Cell Therapy

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