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Clinical

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

Gwen Nichols, MD, discussed the impact of Medicaid reductions on patient care and how oncologists can advocate for accessible cancer treatment during these uncertain times.

Medicaid Cuts Create Barriers for Oncologists and Patients With Cancer

The FDA cleared the investigational new drug application for LTZ-301, a first-in-class myeloid engager immunotherapy, with a phase 1 study set for mid-2025.

FDA Clears IND Application for LTZ-301 in non-Hodgkin Lymphoma 

Gwen Nichols, MD, discussed the potential implications of recent funding cuts, how they are affecting academic and community oncologists, and what may be done to mitigate the damage.

Cancer Research at Risk as NIH Faces Funding Freeze and Cuts

A phase 2 study evaluated the use of ruxolitinib plus standard GVHD prophylaxis in patients with myelofibrosis undergoing transplant.

Ruxolitinib Shows Promise in Preventing GVHD in Myelofibrosis

Axatilimab demonstrated consistent response and durability in chronic graft-versus-host disease, regardless of prior treatments, in a phase 1 AGAVE-201 trial analysis.

Consistent Response, Durability Shown by Axatilimab Regardless of Prior Lines of Therapy in cGVHD 

Assessing the Need for Extended Monitoring After Axi-Cel Infusion

Olalekan O Oluwole, MD, MBBS, associate professor, medicine, hematology/oncology, Vanderbilt Institute for Infection, Immunology and Inflammation, Vanderbilt University Medical Center, discusses the background and rationale of the research he contributed to, which was presented at the 

2025 Transplantation & Cellular Therapy Meetings

.

Axicabtagene ciloleucel (axi-cel; Yescarta) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy that has become a standard treatment for patients with relapsed/refractory large B-cell lymphoma (LBCL). Despite its efficacy, patients with LBCL are typically monitored for 4 weeks post-infusion due to potential cytokine release syndrome (CRS) and neurological events (NEs), according to the presentation.

This particular study presented at the meeting aimed to assess the risk of CRS/NE recurrence after a minimum of 2 weeks, potentially allowing for reduced monitoring.

We have been treating patients with CAR T for many years now, and we believe that we are learning how to use them better and how to better treat patients. So, 1 requirement at the onset of the program by the FDA was that patients needed to stay close to the academics, or wherever they get the CAR T for almost a month. And we know that these CAR T’s are a one time infusion, and all the [adverse] effects that they cause early on will be really early after the treatment. So, it seems reasonable to go back and look and see whether indeed we see all these [adverse] effects early, or whether indeed we see them for the whole 28 days.

 That was really the motivation for this study, to try to look back and cluster all the statical release syndrome, all the neurological events, and find out whether, indeed they recover early or whether they extend for the whole time. So, that was really the hypothesis.

Kersten MJ, Oluwole OO, Speth K, et al. Incidence of cytokine release syndrome and neurological events in patients with relapsed or refractory large B-cell lymphoma at and beyond 2 weeks following axicabtagene ciloleucel infusion. Presented at: 2025 Transplant and Cellular Therapy Meetings; February 12-15, 2025; Honolulu, HI. Abstract 311.

Videos

Olalekan O Oluwole, MD, MBBS, discusses the background and rationale of the research he contributed to, which was presented at the 2025 Transplantation & Cellular Therapy Meetings.


News

Conference News

Dreyling Discusses the Impact of the TRIANGLE Study

Martin Dreyling, MD, University Hospital LMU Munich, in Germany, discusses how the safety and efficacy results from the TRIANGLE study (NCT02858258) in mantle cell lymphoma (MCL) differ from prior expectations.

The TRIANGLE study sought to evaluate whether standard treatment with autologous stem-cell transplantation (ASCT) was superior to a treatment adding ibrutinib (Imbruvica), but without ASCT, in patients with MCL.

 the results from the study demonstrate significant advancements in the treatment of younger patients with MCL. Progression-free survival and overall survival were both significantly improved in the experimental arms containing ibrutinib, with a clinically meaningful benefit of approximately 10% vs the standard treatment. Additionally, rituximab maintenance, when combined with ibrutinib, continues to enhance patient outcomes, further supporting its inclusion in treatment protocols.

Regarding the role of ASCT, Dreyling says that it is no longer required for the overall patient group receiving ibrutinib-based therapy. However, approximately 10% of very high-risk patients still derive benefit from the addition of ASCT. These results underscore the progress made while highlighting areas that require personalized treatment strategies.

Well, it is fair to say some of these results were somewhat expected and others were surprising. So, first of all, when it comes to the modified progression-free survival, which was the primary study aim, we somewhat expected that the addition of the targeted treatment does improve the outcome. What was somewhat a surprise is that also ibrutinib, instead of autologous stem cell transplant, still resulted in a significant improvement of progression-free survival.

And finally, what is somewhat surprising, and that is in contrast to a number of prior studies that we could increase overall survival in the range of 10%, so 1 out of 10 patients, and that is really a major improvement, which means, essentially, whatever kind of salvage treatment you consider, you will not catch up for the advantage in first-line treatment.

Martin Dreyling, MD, discusses how the safety and efficacy results from the TRIANGLE study in mantle cell lymphoma differ from prior expectations. 


AI's Role in Differentiating MDS and Pre-MDS at ASH 2024

Palak Dave, a postdoctoral fellow at Moffitt Cancer Center and Research Institute, discusses the diagnostic challenges between myelodysplastic syndrome (MDS) and pre-MDS conditions, such as idiopathic cytopenia of undetermined significance (ICUS) and clonal cytopenia of undetermined significance (CCUS).


While pre-MDS conditions exhibit abnormalities similar to MDS, their severity is not as pronounced. The manual diagnosis of these conditions is often hindered by subjectivity, leading to variability in how patients are categorized. This inconsistency can result in different classifications for similar cases, making the diagnosis challenging and unreliable.

In response, Dave presents a study to be discussed at the 2024 American Society of Hematology (ASH) Annual Meeting and Exposition. The research explores the use of artificial intelligence (AI) to standardize and accelerate the diagnosis of MDS and pre-MDS conditions.

The AI approach employs deep learning to distinguish MDS from pre-MDS by analyzing bone marrow aspirate smear images alone, without relying on additional clinical data, genetic tests, or other inputs. The study aims to evaluate how effectively this method can differentiate between the conditions based solely on pathology images, potentially leading to more consistent and accurate diagnoses. This innovative use of AI could improve the diagnostic process and help clinicians make more reliable decisions for patients.



The main difference between MDS and pre-MDS conditions lies in the threshold of abnormalities. In pre-MDS conditions, such as ICUS and CCUS, they do have abnormalities similar to MDS, but not as high as MDS. When they analyze these things manually, there are challenges, [particularly due to] subjectivity. This subjectivity can result in variability, potentially causing a patient to be categorized differently. To address this, we are working to standardize the process to ensure more consistent and reliable classification.

It is a deep learning approach designed to automatically distinguish MDS from pre-MDS conditions using only bone marrow aspirate smear images. No additional clinical data, genetic testing, or other inputs are involved—just image data. The goal is to explore how accurately this method can perform using only pathology images.

Palak Dave discusses the diagnostic challenges between myelodysplastic syndrome and pre-MDS conditions.

Breaking Down T-Cell Therapies: TCR and CAR T Mechanisms

Paulina Velasquez, MD, assistant faculty member, St. Jude Children’s Research Hospital, discusses the differences between T-cell receptor (TCR)-based and chimeric antigen receptor (CAR) T-cell therapies.

 but differ significantly in their mechanisms and antigen recognition capabilities. TCR-based T cells are MHC-dependent, meaning they are limited to treating patients with specific MHC types. They can recognize both intracellular and cell surface antigens by associating with MHC, providing a broad range of targets. Their exclusive specificity minimizes off-target effects. However, TCR T cells lack additional co-stimulatory signals, which can limit their expansion but reduce the likelihood of exhaustion, making them potentially longer-lasting.

In contrast, CAR T cells are MHC-independent, enabling them to treat a broader patient population regardless of MHC type. They primarily target cell surface antigens and incorporate co-stimulatory domains, which promote greater expansion and persistence of T cells. However, the increased activation and persistence can also lead to higher rates of T cell exhaustion, potentially reducing their long-term effectiveness.

Each approach offers unique advantages and limitations. TCR-based therapies are versatile in antigen recognition but restricted to certain populations and may not expand as effectively. CAR T cells offer broader accessibility and better initial expansion but face challenges with exhaustion and antigen specificity. The balance between these factors guides the choice of therapy based on the clinical scenario.

 Talking about T-cell–based cell therapies, there are 2 different strategies that are the mainstay at the moment, one being TCR–based T-cell therapies and the other ones being chimeric antigen receptor–based T-cell therapies.

Those 2 strategies use T cells, and although they have similarities, when you think about the way they work, they differ in what antigen is being recognized. For example, one strategy, the TCR-based strategy, is MHC-dependent. So it is going to work for just a certain group of people.

CAR T cells, on the other hand, operate through an MHC-independent mechanism. This is advantageous because it removes the limitation to a certain population. However, they are mostly limited to targeting cell surface antigens. CAR T cells do have additional co-stimulation, which allows them to persist longer and expand better. But at the same time, as mentioned, the flip side is that they can become more exhausted, which can impact their effectiveness.

This transcription has been edited for clarity with AI.

Paulina Velasquez, MD, discusses the differences between T-cell receptor-based and chimeric antigen receptor T-cell therapies.

Merryman Discusses the Role of MRD in Lymphoma Care and Trials

Reid Merryman, MD, clinical investigator and assistant professor at Dana-Farber Cancer Institute, discusses which patients are typically monitored for minimal residual disease (MRD) and whether there are specific subtypes or stages where the assessment is particularly critical.

In addition, Merryman explains how MRD is currently being used in clinical trials.

I would say for lymphoma, if we take out [chronic lymphocytic leukemia (CLL)] for lymphoma right now, MRD is not a standard part of clinical practice. We really need prospective, randomized, phase 3 trials to let us know how best to use MRD to guide treatment. So, outside of trials and clinics, I am not testing MRD for my [patients with] lymphoma.

So, I think we are seeing a lot of trials tracking MRD. I would say that almost all trials now are building a collection of plasma samples so that they can look and see how MRD changes with treatment. And we are just starting to see trials that are using MRD to guide therapies. I think there are a few different ways that MRD can be used. So, we can look at changes in MRD at an early time point and then use that to either deescalate therapy or escalate therapy, depending on the MRD status, or, we can use it to guide consolidation, like that mantle cell lymphoma trial I talked about. So, at the end of treatment, we can look at MRD results and we can decide whether we should or should not do additional treatment. There are also some trials that are testing MRD serially and using that to decide when we can stop treatment, and in some cases, when we should restart treatment if MRD emerges. Those are kind of 3 patterns of trials for how to use MRD.

Reid Merryman, MD, discusses which patients are typically monitored for minimal residual disease and whether there are specific subtypes or stages where the assessment is particularly critical.


Erba Explores myeloMATCH Substudies Targeting Genetic Diversity in AML, MDS

Harry Erba, MD, PhD, professor of medicine at Duke Cancer Institute, chair of the SWOG Leukemia Committee, and co-chair of the myeloMATCH Senior Science Council, discusses the specific substudies included in myeloMATCH, a trial representing a significant shift in how acute myeloid leukemia (AML) is treated by addressing the disease's complexity and genetic diversity.

In order to improve outcomes for [patients] with acute myeloid leukemia and myelodysplastic syndromes [MDS], it is critical that we understand the heterogeneity of this patient population in terms of the drivers of the disease pathogenesis. We have a lot of information about the mutations that are present in patients with AML and MDS.

 Out of the 10s of 1000s of genes in each of our cells, there is only a handful, maybe 50 to 60, that are currently mutated in people with acute myeloid leukemia, and they fall into very distinct classes, such as splicing mutations, chromatin modifiers, DNA methylation, enzymes activating signals, transcription factors, cohesin molecules, and such. We truly believe that these mutations underlie a pathogenesis of the disease. We have already started to make great inroads into the treatment of acute myeloid leukemia by identifying some of these targets.

Some of the targets identified are more common like 

ther mutations are now targets for other therapies, such as the Menin inhibitors and patients with 

. myeloMATCH attempts to identify these mutations at the time of diagnosis and then assign patients to clinical trials meant to optimize the initial therapy and then subsequent therapy for these patients based on this mutational analysis.

 myeloMATCH activated on May 16, 2024, and we already have patients accrued to the study. The idea here is that after a patient is screened and the genetic profile is defined, the patient will then be assigned to an appropriate study. Now, we plan to have studies for every subtype that we identified and plan to develop studies for new targets that are identified. But at this point, myeloMATCH is activating with 2 studies: 1 from the Canadian Cancer Trials Group in intermediate-risk AML as defined by [European LeukemiaNet (ELN)] 2017 criteria, and a SWOG study of high-risk, poor-risk, or average-risk karyotype AML as defined by ELN 2017.

 There are other studies coming. We are developing studies for 

, for core binding factors, and those studies are coming for the initial treatment of younger patients with acute myeloid leukemia. We are doing a similar thing for older patients, identifying these mutations and then developing trials.

Harry Erba, MD, PhD, discusses the specific substudies included in myeloMATCH.

Incorporating Immunotherapy Into Hodgkin Lymphoma Treatment Strategies

Stephen M. Ansell, MD, PhD, chair of the Division of Hematology at Mayo Clinic in Rochester, Minnesota, discusses how immunotherapy is being integrated into treatment for patients with advanced stage Hodgkin lymphoma.


Additionally, he explains how the treatment for these patients is becoming more personalized.

One of the regimens, the nivolumab [Opdivo]/AVD [doxorubicin, vinblastine, and dacarbazine]/chemotherapy, has an immune checkpoint blocking antibody, the nivolumab right in the combination, but I think more broadly, PD-1 blockade and agents such as pembrolizumab or nivolumab have really been broadly used in patients with Hodgkin lymphoma, many in the post transplant relapse setting and then subsequently in the salvage treatment combinations before going to a transplant. And now, as I mentioned in the frontline therapy. And the advantages are that you can see benefits for patients in each of these scenarios. In fact, interesting data suggests that using a PD-1 blocking antibody before intensive treatment like a stem cell transplant actually results in significantly greater benefit, suggesting that we are doing something immunological when we do that, that kind of treatment

 I think in many respects, the personalization is really focused on the patient's frailty vs, shall we say, robustness to tolerate treatment. One of the things that has been very interesting is that nivolumab, AVD, and chemotherapy is very well-tolerated in elderly patients. One of the problems with Hodgkin lymphoma is that elderly patients have really been very difficult to treat, purely because of the challenges they have tolerating these treatments. But the use of nivolumab and AVD has actually shown that regimen can be well-tolerated.

Similarly, using brentuximab [vedotin; Adcetris]/AVD, by doing the brentuximab alone first and then the rest of the regimen, has also shown that you can give that to elderly patients. So the personalization is not personalized to the point of understanding the tumor biology. It is more personalized to the understanding of the patient and their needs.

Stephen M. Ansell, MD, PhD, discusses how immunotherapy is being integrated into treatment for patients with advanced stage Hodgkin lymphoma.


Optimizing Treatment Decisions for Patients With CML

Michael J. Mauro, MD, director of the chronic myeloid leukemia (CML) program in the leukemia service at Memorial Sloan Kettering Cancer Center, discusses decision-making for patients with chronic myeloid leukemia (CML).

CML is a complex disease and according to Mauro, decision-making often depends on the stage at diagnosis. He explains that it is crucial to carefully assess both the disease and the patient's overall health, including comorbidities, to find the best treatment plan that offers the highest benefit with the lowest risk.

Mauro shares that treatment should be practical and experts must ensure that patients are not denied the possibility of a curative approach due to fears of adverse events or uncertainty. With multiple therapies available for the treatment of CML, experts can make adjustments based on patient response. As a result, Mauro believes that cure should remain a potential goal for all patients.

 Decision-making for a [patient with] CML can be complicated, depending on the state on the stage you are at when a patient [with CML] is first diagnosed. That is probably the most important point: to sort of do it right [by] looking at all the factors, [including] the disease itself and the patient in great detail–their health, comorbidities, and what is best for them. The [goal should be] to have the highest yield and the lowest risk, to achieve the best response, to probably be practical with milestones and goals of therapy without shortchanging the patient's meaning. Let us not exclude the possibility of a curative approach for all patients with CML or an optimum approach simply based on fear of adverse events or uncertainty.

The good thing is, we have multiple therapies available, so switching and optimization based on the patient’s response can really make headway, [even] if we do not see exactly the perfect trajectory. And again, I think, hopefully, a cure can still be at least a considered goal for all patients.

Michael J. Mauro, MD, discusses decision-making for patients with chronic myeloid leukemia.

Investigational Studies and Therapies in MDS 

David Sallman, MD, myeloid section head and associate member of the Malignant Hematology Department, H. Lee Moffitt Cancer Center and Research Institute, discusses some of the innovative therapies and strategies being investigated in myelodysplastic syndromes (MDS) studies.

 The 1 trial we are maybe most eagerly awaiting for is the VERONA trial [NCT04401748], which is a phase 3 trial of azacitidine with venetoclax versus azacitidine therapy alone. Of course, in AML, this has very much changed the standard-of-care for elderly AML, although it is impacting many patients in all different situations. So, it is a relatively similar type design. I think in MDS, we know that the cytopenia toxicities are a little bit less well tolerated, and thus, we have a lower schedule of venetoclax. There has been a large phase 1, borderline phase 2 study presented by Jacqueline Garcia, MD, at ASH where there are 107 patients, and response rates, at least from composite [complete] response [CR] rates, are significantly higher. Data from our center that we published look relatively identical from that perspective. But…we need to improve overall survival. That is really the key primary end point of the trial, and so that is what we are currently waiting on. I think particularly for patients that can go to allogeneic stem cell transplant, the therapy is very effective. I think it really does induce deeper and what I would call [minimal residual disease (MRD)]-negative remissions, which not has not really been a thing in myelodysplastic syndrome. But I think that the balance of what percentage of patients get there may tip whether or not the trial is positive or not. Although, I think the utilization, at least in the United States, will still be significantly high. They kind of went over those data in detail. Again, we need that trial.

David Sallman, MD, discusses some of the innovative therapies and strategies being investigated in myelodysplastic syndromes studies.

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