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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

A phase 1 trial is evaluating Actimab-A, venetoclax, and ASTX-727 in frontline acute myeloid leukemia, with initial data expected later this year.

Actimab-A Triplet Trial Launches in Frontline AML

The FDA has granted AUTX-703, a first-in-class oral KAT2A/B degrader, fast track designation for the treatment of relapsed/refractory acute myelogenous leukemia.

FDA Fast-Tracks AUTX-703 in Relapsed/Refractory AML

Obecabtagene autoleucel improved outcomes in relapsed/refractory B-cell acute lymphoblastic leukemia with low-risk CAR-HEMATOTOX scores in the 1/2 FELIX trial.

Obe-Cel Linked to Better Outcomes in R/R B-ALL With Low-Risk Scores

The first patient with relapsed/refractory acute myeloid leukemia has received KJ-C2320, an allogeneic CAR T-cell therapy targeting CD38 and developed using the THANK-uCAR platform, in an investigator-initiated trial in China.

First Dose of CD38-Targeting CAR T-Cell Therapy Administered in AML

LYT-200 now has gained fast track designation from the FDA in acute myeloid leukemia in addition to its prior designation for recurrent or metastatic head and neck squamous cell carcinoma.

LYT-200 Gains FDA Fast Track Status in Acute Myeloid Leukemia

Tailoring Treatment for Secondary AML in Older Patients

Eunice S. Wang, MD, chief of the Leukemia Service at Roswell Park Comprehensive Cancer Center, discusses a retrospective study of 105 patients diagnosed with secondary acute myeloid leukemia (AML).


The study focused on mainly patients in their 70s and 80s and analyzed the outcomes of those treated with either lower-dose venetoclax [Venclexta]-based therapy or intensive chemotherapy.

The results revealed that lower-dose chemotherapy was not beneficial for older patients, with a median overall survival of only 5 months. In contrast, those who received intensive chemotherapy followed by transplantation had significantly better outcomes, with a median survival closer to 10 months. Patients who underwent transplantation survived for over a year, while those on lower-intensity therapy often had survival times as short as 3 to 5 months.

 We conducted a retrospective study of patients at Roswell Park who had been diagnosed with secondary AML. We looked at their prior therapies and outcomes. [Among the 105 patients identified]—predominantly in their 70s and 80s, with ages ranging all of the way up to 91—we analyzed the impact of their treatments. Patients received either lower-dose venetoclax-based therapy or intensive chemotherapy, [such as a standard intensive approach.

Our findings showed that lower-dose chemotherapy was not necessarily beneficial for this older age population. Patients treated with intensive chemotherapy, ideally followed by transplantation, had significantly better outcomes. The median overall survival across all 105 patients was 7.7 months. However, those who received intensive therapy had a median survival of closer to 10 months, compared with 5 months for those receiving lower-intensity therapy. Furthermore, patients who underwent transplantation lived longer than a year. Patients treated with lower-intensity therapy often had survival as short as 3 to 5 months.

These results emphasize that lower-intensity therapy is not universally appropriate for all older patients with AML. Prior therapies and disease history must be carefully considered when treating these individuals. Typically, older patients without a history of MDS or prior treatment might have a median survival of approximately 14 months, which we did not observe in this subgroup. This underscores the importance of tailoring treatment strategies for secondary AML in older adults. This was the key finding of our abstract.

Videos

Eunice S. Wang, MD, discusses a retrospective study of 105 patients diagnosed with secondary acute myeloid leukemia. 


News

New Insights Into Secondary AML Treatment 

Eunice S. Wang, MD, chief of the Leukemia Service at Roswell Park Comprehensive Cancer Center, discusses research behind optimal therapy for acute myeloid leukemia (AML) secondary to other malignancies, particularly in patients with prior myelodysplastic syndrome (MDS). These patients had previously been treated for MDS with hypomethylating agents such as azacitidine or decitabine.

This research, which was presented at the 2024 ASH Annual Meeting and Exposition, emphasizes the importance of tailoring treatment for older patients with secondary AML, taking into account their unique disease history and prior therapies to improve outcomes.

 Our abstract focused on optimal therapy for acute myeloid leukemia secondary to other malignancies or states. Specifically, we were looking at patients who had secondary AML following a prior diagnosis of myelodysplastic syndrome, who had been treated previously for their myelodysplastic syndrome with hypomethylating agents.

As the general population ages, the age of presentation of acute myeloid leukemia has also risen. The majority of patients diagnosed with AML are now often in their 70s or 80s. Many of these patients have a history of a pre-leukemic state, such as myelodysplastic syndrome. Standard therapy for myelodysplastic syndrome involves agents like azacitidine and decitabine. However, when these older, less fit individuals progress to acute myeloid leukemia, they are often offered treatment with the same drugs, combined with a BCL-2 inhibitor like venetoclax [Venclexta].

Patients with secondary AML] were excluded from the initial clinical trials evaluating the benefit of venetoclax with, for example, azacitidine for acute myeloid leukemia treatment. [Our study] aimed to assess whether these patients, having already been treated with hypomethylating agents for MDS, benefit from the standard azacitidine-based therapy for AML or require a different treatment approach.

Eunice S. Wang, MD, discusses research behind optimal therapy for acute myeloid leukemia secondary to other malignancies, particularly in patients with prior myelodysplastic syndrome.

Real-World Outcomes of Oral Azacitidine Maintenance in AML Presented at ASH 2024

, Fatima Tuz Zahra, MD, hematology/oncology fellow at Moffitt Cancer Center, University of South Florida, Tampa, discusses the methods and design of a retrospective analysis of 65 patients with acute myeloid leukemia (AML) treated with oral azacitidine maintenance after achieving complete remission, which is being presented at the 2024 American Society of Hematology (ASH) Annual Meeting and Exposition.

The study was conducted between September 2020 and June 2024 at Moffitt Cancer Center and its findings align with those seen in the QUAZAR AML-001 trial (NCT01757535), which previously demonstrated significant benefits in overall survival and relapse-free survival.

Results from the study ultimately revealed good outcomes for younger patients with AML in their 50s. Further, while the QUAZAR AML trial primarily included older patients with AML, this study suggests that younger patients can also benefit from oral azacitidine maintenance.

 The therapy with oral azacitidine for maintenance was approved following the phase 3 QUAZAR AML study [NCT01757535], which demonstrated definitive benefits in overall survival and relapse-free survival. For our study, we looked at patients treated between September 2020 and June 2024. Some patients had started therapy recently, so that was the timeline we defined. Retrospectively, we reviewed our pharmacy records to identify patients prescribed oral azacitidine. We included only those who completed at least 1 cycle of therapy, excluding those who used it briefly to provide a clearer insight into treatment outcomes.

 We included adults 18 years or older and excluded patients who had undergone allotransplant to avoid confounding their survival outcomes. After identifying our cohort, we conducted descriptive statistics and performed survival analysis using Kaplan-Meier methods.

Zahra FT, Ong F, Walgenbach D, et al. Real world outcomes of oral azacitidine maintenance therapy for acute myeloid leukemia: A single center experience. Presented at: ASH Annual Meeting. December 7-10, 2023. Abstract: 2415.

Fatima Tuz Zahra, MD, discusses the methods and design of a retrospective analysis of 65 patients with acute myeloid leukemia treated with oral azacitidine maintenance after achieving complete remission.

Conference News

Blinatumomab Plus Chemotherapy Improves Survival in Ph-Negative B-ALL

Mark R. Litzow, MD, professor of medicine in the Division of Hematology at the Mayo Clinic, discusses the findings from the ECOG-ACRIN E1910 trial (NCT02003222) which evaluated blinatumomab (Blincyto) added to chemotherapy vs chemotherapy alone in B-cell precursor acute lymphoblastic leukemia (B-ALL).

 We found that from the time of the randomization, the 3-year overall survival in the blinatumomab plus chemotherapy patients was 85% compared with 68% for the patients that got chemotherapy. This was a highly significant difference. The 

 value was 0.002, so this is encouraging for us to see.

Amgen, which is the supplier of blinatumomab, took this data to the FDA and got a new indication for blinatumomab. It is already approved for [patients with] relapsed/refractory and MRD-positive [disease], and now, it is approved in the consolidation phase of chemotherapy. The addition of blinatumomab to chemotherapy in this setting has shown improvement in survival and has been a major advance.

 Now, what we did find in the study was that of the 488 patients that we enrolled at the beginning, only 286 patients made it to the randomization phase. Of those 286, 62 were MRD-positive. We were going to randomize those patients, but when the FDA approved blinatumomab for MRD-positive disease, we no longer randomized them and assigned them. We had 62 of those patients, and then there were 224 MRD-negative patients, 112 in each arm.

The point I make here is that if we can move the immunotherapy up earlier in the course of treatment, we hopefully will be able to increase the response rate and lessen the number of patients that we lose from chemotherapy. That is the trend in the field, to move immunotherapeutic agents up earlier in a treatment course. The hope is that eventually we—and we are already starting to see this—can lower the amount of chemotherapy that we give. Whether we would eventually be able to completely eliminate chemotherapy is not known at this time, but it may be a possibility in the future.

Mark R. Litzow, MD, discusses the findings from the ECOG-ACRIN E1910 trial which evaluated blinatumomab added to chemotherapy vs chemotherapy alone in B-cell precursor acute lymphoblastic leukemia.


Behind the ECOG-ACRIN E1910 Trial: Blinatumomab in B-ALL

Mark R. Litzow, MD, professor of medicine in the Division of Hematology at the Mayo Clinic, discusses the methods and design from the ECOG-ACRIN E1910 trial (NCT02003222).

In the study, experts evaluated blinatumomab (Blincyto) when added to chemotherapy vs chemotherapy alone for the treatment of patients with B-cell precursor acute lymphoblastic leukemia (ALL).

 In my presentation, I presented a study that I had the privilege of leading. It is called the E1910 trial through the ECOG-ACRIN Cooperative Group. This was a National Clinical Trials Network intergroup trial in the United States. We took patients between the ages of 30 and 70 with B-cell precursor ALL, and we enrolled 488 of these patients. These patients were Philadelphia chromosome-negative, and we gave them 2 months of induction chemotherapy. If patients achieved a conventional morphologic complete remission, they stayed on study. If they did not, they went off the study.

 We had an 81% complete remission rate. They then got an intensification cycle of chemotherapy for [central nervous system] prophylaxis, and then we assessed their measurable residual disease, or MRD status, by flow cytometry. If they were MRD-negative, we randomized them to get the control arm of 4 cycles of conventional consolidation chemotherapy followed by maintenance therapy, or we gave them the same 4 cycles of consolidation chemotherapy, but added 4 cycles of the blinatumomab, which is given by a continuous [intravenous] infusion for 4 weeks.

 So, those patients got 2 cycles of blinatumomab when they were randomized, then 3 cycles of chemotherapy, then another cycle of blinatumomab, another cycle of chemotherapy, and then the fourth cycle of the blinatumomab. They then went on to maintenance therapy, and again, either group of patients could go onto an allogeneic transplant if their physician felt that was indicated. About 20% of the patients did go for a transplant.

Mark R. Litzow, MD, discusses the methods and design used in the ECOG-ACRIN E1910 trial.

Advancing Transplant Outcomes With Innovations in GVHD Prevention and Care

Partow Kebriaei, MD, Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine, MD Anderson Cancer Center, discusses what factors may influence the decision for transplant in patients with acute lymphoblastic leukemia (ALL) and how experts determine who is best fit for transplant.

| I think with regards to transplant and from the transplant side, we have made great strides, especially in the area of graft-vs-host disease prophylaxis. So, because of the great work pioneered by the group at Johns Hopkins, we can now use post transplant cyclophosphamide to reduce the risk for graft-vs-host disease and to allow us to transplant with mismatched donors.

 So, in order to be able to successfully perform a transplant, you have to have an available donor, and you have to have a fit patient. I think today, in 2024 we can say that most patients will have an available donor.

 The second is you have to have a fit patient. And I think again, this is where highly effective immunotherapies in ALL help us, because we are now talking about inducing, for instance, a person with Ph-positive ALL with a chemotherapy-free regimen, so the patient actually can get a transplant, if the patient, in fact, needs a transplant, and is very fit. So, for instance, in the chemotherapy-free regimen trial that was what was reported by the Italian group, in the group that did get a transplant following a chemotherapy-free regimen for Ph-positive ALL, the group that got transplanted had an extremely low treatment-related mortality rate. At the end, we are changing that group who does need a transplant, but hopefully we are also getting to transplant with more fit patients, and at the end of the day, then overall survival is improved for all patients.

Partow Kebriaei, MD, discusses what factors may influence the decision for transplant in patients with acute lymphoblastic leukemia and how experts determine who is best fit for transplant.


Using MRD to Predict Outcomes in Acute Myeloid Leukemia

Measurable residual disease (MRD) in acute myeloid leukemia (AML) is measured through flow cytometry or molecular testing that specifically treats subgroups like 

mutations. MRD is a powerful tool to predict long-term outcomes in patients with AML as well as detect early relapse before it becomes morphologically evident. If MRD levels rise, even slightly, it may indicate a potential relapse. While intervention is not immediate for molecular relapse, MRD is monitored closely.

Here, Sangeetha Venugopal, MD, MS, physician in the Department of Medicine, Division of Hematology, at the Sylvester Comprehensive Cancer Center at the University of Miami, discusses how MRD is used in the course of AML treatment. 

We measure the residual disease by 2 ways. One is through flow cytometry, and the other one is specific testing for molecular subgroups. So the only specific testing that is approved to treat approved for MRD is for 

, because looking at the measurable residual disease, we want to look at a deeper level than the morphology and the pulse sequencing. So the measurable residual disease needs depth of at least 10

 five. So we look at measurable disease in a few subgroups. One is core binding factor. And for 

-mutated AML and for all AML that is using flow cytometry, we look at the measurable residual disease. 

The reason why we are looking at measurable residual disease is because it predicts long-term outcomes in a patient with AML. For example, in a patient with core binding factor leukemia, if we track the measurable residual disease by, especially for the inv(16) and t(8;21) translocation, and when we track it, we can actually find if, at some point, if they lose that response. For example, all along it is negative, and suddenly we see something like popping up, which is positive, even though it is low-level positive. Then we increase the frequency to see if we can intervene before there is a frank morphological relapse. Right now, we do not intervene if it is just molecular relapse; however, we monitor the MRD more frequently than usual if we see that the level of MRD is rising. 

Sangeetha Venugopal, MD, MS, discusses how measurable residual disease is used during the course of treatment of AML. 

Navigating the Molecular Landscape of Acute Myeloid Leukemia

The molecular landscape of acute myeloid leukemia (AML) is constantly changing. Genetic testing is crucial at diagnosis to determine the presence of specific molecular aberrations. FLT3 inhibitors are incorporated into frontline treatments on day 8, but their use depends on the genetic makeup of the AML. Additionally, molecular testing is conducted at various stages of treatment including at diagnosis to determine the initial genetic profile, remission to assess the presence of residual molecular disease, and relapse to identify the dominant clone driving the leukemia. Molecular testing helps determine prognosis and guides treatment decisions, including the need for transplant. By understanding the molecular landscape, clinicians can tailor treatments to achieve the best possible outcomes.

Here, Sangeetha Venugopal, MD, MS, physician in the Department of Medicine, Division of Hematology, at the Sylvester Comprehensive Cancer Center at the University of Miami, discusses how molecular testing factors into AML treatment protocols. 

The molecular landscape of AML is dynamic, so we do genetic testing at diagnosis, because we incorporate FLT3 inhibitors on day 8. So we need to know the genetic makeup of the AML before we decide on whether we are going to add a FLT3 inhibitor or not. The FLT3 inhibitors are added in frontline treatments, so that is in patients with newly diagnosed AML. We do it at all time points, meaning we do a diagnosis to incorporate the molecularly targeted treatment, and we do at remission, which is treatment assessment of the bone marrow at the end of the first cycle of treatment to know if the molecular aberration is still present or absent. That would help us decide how the how the prognosis is going to be.

Some of these patients may be going to transplant, and in those patients, we want to make sure that they don't have any of these molecular aberrations left to give a best possible outcome for transplant. And after that, we do molecular testing at any time the AML relapses in a patient, mainly because we need to know whether what is the dominant clone that is driving this leukemia? Was this the same molecular aberration that was present at diagnosis, or is this something new that will affect the change in management?

Sangeetha Venugopal, MD, MS, discusses the dynamic landscape of molecular targets in acute myeloid leukemia. 

Understanding Social Toxicity as a New Measure in AML Care

Claire Saxton, MBA, executive vice president of insights and impact at Cancer Support Community, discusses findings from a study of 109 patients with acute myeloid leukemia (AML) looking at social toxicity.

Key findings from the study showed that social toxicity was significantly correlated with poorer outcomes, including higher levels of anxiety, depression, and financial strain in these patients with AML. The most common social toxicity indicator was changes in work, school, or home life. Further, patients under the age of 65 years and those patients who were currently receiving treatment experienced higher levels of social toxicity.

Here, Saxton explains what a community oncologist should know about these results and what resources are available for their patients.

These findings suggest that social toxicity, the negative social impact of cancer, cancer diagnosis or cancer treatment, can be assessed, so we have a tool now for doing that, and this is an effect that we see in a majority of [patients with] cancer. So, because social toxicity was related to other patient-reported outcomes, especially for those younger than 65 and those currently receiving treatments, it is really important for us to investigate it in patients and see how and what we can do to mitigate some of that impact.

Organizations like Cancer Support Community and our local cancer support communities are there for patients and as a resource. There are many other patient advocacy groups that are there as a resource, and we strongly encourage you to connect your patients to those resources so that they can build that support community that they need in order to cope with the impact of cancer.

Fortune EE, Rogers KP, Lawrence C, et al. Measuring social toxicity in acute myeloid leukemia. 

. 2023;142(1):5182. doi:10.1182/blood-2023-177783

Claire Saxton, MBA, discusses findings from a study looking at social toxicity in acute myeloid leukemia.

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