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Myelodysplastic Syndromes
Symptom Management

Luspatercept for Anemia in Patients With Lower-Risk Myelodysplastic Syndromes: Long-Term Follow-up

In a long-term follow-up of the German phase II PACE-MDS trial reported in the Journal of Clinical Oncology, Uwe Platzbecker, MD, and colleagues described erythroid, neutrophil, and platelet hematologic improvement rates with luspatercept treatment for anemia in patients with lower-risk...

Leukemia
Lymphoma
Myelodysplastic Syndromes

FDA Approves Pemigatinib for Patients With Myeloid/Lymphoid Neoplasms and FGFR1 Rearrangement

On August 26, the U.S. Food and Drug Administration (FDA) approved pemigatinib (Pemazyre), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. Myeloid/lymphoid neoplasms with...

Myelodysplastic Syndromes

Low-Dose Decitabine and Azacitidine in Lower-Risk MDS

As reported in NEJM Evidence by Sasaki et al, extended follow-up of a phase II trial showed good outcomes with low doses of the hypomethylating agents decitabine and azacitidine in previously untreated patients with lower-risk myelodysplastic syndromes (MDS). Study Details The study included 113...

Leukemia
Myelodysplastic Syndromes

Eprenetapopt/Azacitidine Maintenance After Allogeneic HSCT for TP53-Mutant AML and MDS

In a phase II trial reported in the Journal of Clinical Oncology, Mishra et al found that maintenance treatment with the first-in-class small-molecule p53 reactivator eprenetapopt plus azacitidine following allogeneic hematopoietic stem cell transplantation (HSCT) was associated with “encouraging”...

Genomics/Genetics
Myelodysplastic Syndromes
Leukemia

Demethylation and Upregulation of the Oncogene SALL4 After Hypomethylating Therapy

In a study reported in The New England Journal of Medicine, Liu et al found that hypomethylating therapy was associated with upregulation of the oncogene SALL4 in a high proportion of patients with myelodysplastic syndrome. They also identified the gene region that is demethylated and responsible...

Leukemia
Myelodysplastic Syndromes
Genomics/Genetics

Targeted Therapy Emavusertib Shows Activity in Patients With MDS or AML With Specific Mutations

Mutations in SF3B1 and U2AF1 can drive overexpression of activated IRAK4—which regulates inflammation and promotes cancer cell growth and survival—and are associated with a poor prognosis for patients with high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Emavusertib is a...

myelodysplastic syndromes

Ruben A. Mesa, MD, on Myelofibrosis: Phase III Results on Momelotinib vs Danazol

Ruben A. Mesa, MD, of Mays Cancer Center at UT Health San Antonio MD Anderson Cancer Center, discusses new findings from the MOMENTUM study. This trial showed that in symptomatic and anemic patients with myelofibrosis, momelotinib was superior to danazol for symptom and spleen responses, as well as transfusion requirements (Abstract 7002).

Hematologic Malignancies
Leukemia
Lymphoma
Myelodysplastic Syndromes

Allogeneic Transplantation for Hematologic Neoplasms in Adults

“The value of experience is not in seeing much, but in seeing wisely.” —Sir William Osler To complement The ASCO Post’s continued comprehensive coverage of the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting...

Myelodysplastic Syndromes

Study Defines Stem Cell Groups That May Drive Development of Myelodysplastic Syndromes

Researchers have discovered that treatment resistance in patients with myelodysplastic syndromes (MDS) may be caused by two distinct classes of stem cells and identified possible therapeutic approaches that target these cells. Their findings, which could have significant benefits for patients with...

Myelodysplastic Syndromes

PANTHER: No Significant Benefit for Pevonedistat Plus Azacitidine in Higher-Risk Myelodysplastic Syndrome

The phase III PANTHER trial, which evaluated pevonedistat plus azacitidine vs azacitidine alone in higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, and low–blast count acute myeloid leukemia (AML) failed to meet its primary endpoint of event-free survival,1 though lessons...

Myelodysplastic Syndromes

PANTHER: No Significant Benefit for Pevonedistat Plus Azacitidine in Higher-Risk Myelodysplastic Syndrome

The phase III PANTHER trial, which evaluated pevonedistat plus azacitidine vs azacitidine alone in higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, and low–blast count acute myeloid leukemia (AML), failed to meet its primary endpoint of event-free survival, though lessons...

leukemia
myelodysplastic syndromes

Alba Rodriguez-Meira, DPhil, on TP53-Mutated Leukemic Transformation in Myeloproliferative Neoplasms

Alba Rodriguez-Meira, DPhil, of the University of Oxford, discusses a comprehensive analysis of the genetic, cellular, and molecular landscape of TP53-mediated transformation, providing insights into the evolution of chronic hematologic malignancies toward an aggressive acute leukemia. Because TP53 is the most commonly mutated gene in human cancer, these findings may well be of broad relevance (Abstract 3).

Leukemia
Myelodysplastic Syndromes

Study Identifies Factors for Severe COVID-19 Illness Among Patients With Acute Leukemia or MDS

In separate analyses of 257 patients with acute leukemia or myelodysplastic syndrome (MDS) who developed COVID-19 and are part of the American Society of Hematology (ASH) RC COVID-19 Registry for Hematology, both neutropenia and having active MDS or leukemia (vs being in remission) were found to...

Myelodysplastic Syndromes
Leukemia
COVID-19

Antibody Response to Second Dose of mRNA COVID-19 Vaccine in Patients With AML and MDS

In one of the largest studies to date of the antibody response to vaccination against COVID-19 in people who had been treated for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), patients responded well to two doses of the Moderna mRNA vaccine and saw a pronounced increase in levels ...

Myelodysplastic Syndromes

Personalized Risk Prediction Model for Patients With Myelodysplastic Syndromes

As reported in the Journal of Clinical Oncology, Aziz Nazha, MD, and colleagues have developed a model for predicting the risk of disease progression for individual patients with myelodysplastic syndromes (MDS). To develop the prediction model for overall survival and leukemic transformation,...

Myelodysplastic Syndromes

Continuous Azacitidine vs Reduced-Intensity Conditioning HSCT in Older Patients With Advanced Myelodysplastic Syndrome

In the German phase II VidazaAllo study reported in the Journal of Clinical Oncology, Kröger et al found that switching from azacitidine to reduced-intensity conditioning allogeneic hematopoietic stem cell transplantation (HSCT) contingent upon donor availability was associated with better outcomes ...

Breast Cancer
Myelodysplastic Syndromes

FDA Pipeline: Designations for Therapies in Myelodysplastic Syndromes and Triple-Negative Breast Cancer

Recently, the U.S. Food and Drug Administration (FDA) granted special designation status to treatments for myelodysplastic syndromes and advanced triple-negative breast cancer. Breakthrough Therapy Designation for Venetoclax in Combination With Azacitidine for  Myelodysplastic Syndromes Venetoclax...

Myelodysplastic Syndromes

Reduced-Intensity Conditioning Allogeneic HCT Based on Donor Availability in Older Patients With Advanced Myelodysplastic Syndrome

In a study reported in the Journal of Clinical Oncology, Nakamura et al found that use of reduced-intensity conditioning allogeneic hematopoietic cell transplantation (HCT) in older patients with advanced myelodysplastic syndrome (MDS) with an available matched donor improved overall survival vs...

Myelodysplastic Syndromes

Novel Insights in Myelodysplastic Syndromes: Highlights From 2020 ASH Meeting

To complement The ASCO Post’s comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel clinical trial findings in myelodysplastic syndromes (MDS). For full details of...

Myelodysplastic Syndromes

Oral Azacitidine in Lower-Risk Myelodysplastic Syndromes

In a phase III trial reported in the Journal of Clinical Oncology, Guillermo Garcia-Manero, MD, and colleagues found that oral azacitidine significantly improved red blood cell (RBC) transfusion independence vs placebo in patients with lower-risk myelodysplastic syndromes. An increase in early...

Myelodysplastic Syndromes
Immunotherapy

Identification of Genomic Subgroups of Patients With Myelodysplastic Syndromes: New Prognostic Modeling

In a study reported in the Journal of Clinical Oncology, Bersanelli et al reported that researchers in the EuroMDS Project found that patients with myelodysplastic syndromes (MDS) could be classified into eight distinct subtypes based on genomic characteristics. They also developed a new prognostic ...

Leukemia
Myelodysplastic Syndromes
Genomics/Genetics

Whole-Genome Sequencing vs Cytogenetic Analysis in Myeloid Cancers

In a study reported in The New England Journal of Medicine, Duncavage et al found that whole-genome sequencing in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) provided rapid genomic profiling that improved diagnostic yield vs conventional cytogenetic analysis, as...

Leukemia
Myelodysplastic Syndromes
Genomics/Genetics

Eprenetapopt Plus Azacitidine in TP53-Mutated MDS and AML

In a Groupe Francophone des Myélodysplasies phase II study reported in the Journal of Clinical Oncology, Cluzeau et al found that the combination of eprenetapopt and azacitidine produced high response rates in previously untreated patients with high-risk TP53-mutated myelodysplastic syndromes (MDS) ...

Myelodysplastic Syndromes
Geriatric Oncology

Transplant May Improve Survival in Older Patients With High-Risk Myelodysplastic Syndrome

Stem cell transplants are not frequently offered to older patients with high-risk myelodysplastic syndromes (MDS). According to a study from the Blood and Marrow Transplant Clinical Trials Network (BMTCTN 1102), these patients may indeed achieve a survival benefit from stem cell transplant. As...

Myelodysplastic Syndromes

First-in-Class Eprenetapopt Plus Azacitidine for TP53-Mutant Myelodysplastic Syndromes

In a phase Ib/II study reported in the Journal of Clinical Oncology, David A. Sallman, MD, and colleagues found that the combination of azacitidine and the first-in-class small-molecule agent eprenetapopt produced high response rates in patients with TP53-mutant myelodysplastic syndromes (MDS)....

Myelodysplastic Syndromes

Lenalidomide Plus Epoetin Alfa vs Lenalidomide Alone in Refractory Non-del(5q) MDS

In a phase III U.S. Intergroup trial reported in the Journal of Clinical Oncology, Alan F. List, MD, and colleagues found that treatment with lenalidomide plus epoetin alfa increased the rate of major erythroid response vs lenalidomide alone in patients with lower-risk, non-del(5q) myelodysplastic...

Leukemia
Myelodysplastic Syndromes

Intensified Reduced-Intensity Conditioning for Allogeneic Stem Cell Transplantation in AML or MDS

In the phase II FIGARO trial reported in the Journal of Clinical Oncology, Craddock et al found that intensified reduced-intensity conditioning with fludarabine/amsacrine/cytarabine–busulfan (FLAMSA-Bu) did not improve outcomes following allogeneic stem cell transplantation vs standard...

Leukemia
Myelodysplastic Syndromes

ASH 2020: Role of Venetoclax in High-Risk Myeloid Malignancies

The BCL2 inhibitor venetoclax can be safely added to standard therapies for some high-risk myeloid blood cancers, and in early studies, the combination showed improved outcomes, according to two reports presented by Jacqueline S. Garcia, MD, and colleagues at the 2020 American Society of Hematology ...

Myelodysplastic Syndromes

Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplant May Improve Survival in Older Patients With High-Risk MDS

Stem cell transplants are not frequently offered to older patients with high-risk myelodysplastic syndromes (MDS). According to a study from the Blood and Marrow Transplant Clinical Trials Network (BMTCTN 1102), these patients may indeed achieve a survival benefit from stem cell transplant. As...

myelodysplastic syndromes

Corey Cutler, MD, MPH, on MDS: Evaluating Treatments in Older Patients With Advanced Disease

Corey Cutler, MD, MPH, of Dana-Farber Cancer Institute, discusses results from a multicenter trial that compared reduced-intensity allogeneic hematopoietic cell transplantation to hypomethylating therapy or best supportive care in patients aged 50 to 75 with advanced myelodysplastic syndromes (Abstract 75).

Myelodysplastic Syndromes

Imetelstat in Lower-Risk MDS With High Transfusion Dependence

In the phase II portion of the phase II/III MDS3001 study reported in the Journal of Clinical Oncology, David P. Steensma, MD, and colleagues found that imetelstat—a first-in-class competitive inhibitor of telomerase enzymatic activity—markedly reduced the need for red blood cell transfusion in...

Myelodysplastic Syndromes

Novel Treatments Emerge for Patients With Lower-Risk Myelodysplastic Syndromes

Patients with lower-risk myelodysplastic syndromes (MDS) who are dependent on red blood cell transfusions have limited options, especially if they are no longer responding to erythropoiesis-stimulating agents. Research presented during the virtual edition of the 25th European Hematology Association ...

Kidney Cancer
Lung Cancer
Myelodysplastic Syndromes
Solid Tumors
Skin Cancer
Lymphoma
Pancreatic Cancer
Breast Cancer
Immunotherapy

FDA Pipeline: Designations in Kidney and Lung Cancers, Myelodysplastic Syndromes, and More

Over the past few weeks, the U.S. Food and Drug Administration (FDA) has issued designations and accepted applications for novel agents, as well as approved companion diagnostics. We summarize these regulatory movements below. Breakthrough Therapy Designation for MK-6482 in von Hippel-Lindau...

Myelodysplastic Syndromes
Genomics/Genetics

Role of TP53 Mutations on Disease Severity in Myelodysplastic Syndromes

Considered the “guardian of the genome,” TP53 is the most commonly mutated gene in patients with cancer. TP53's normal function is to detect DNA damage and prevent cells from passing this damage on to daughter cells. When TP53 is mutated, the protein made from this gene, called p53, can no longer...

Myelodysplastic Syndromes

Pevonedistat Plus Azacitidine May Be of Benefit in Higher-Risk Myelodysplastic Syndromes

In higher-risk myelodysplastic syndromes (MDS), a global phase II open-label study found that the combination of pevonedistat plus azacitidine was associated with a trend toward improved event-free survival and numerically longer overall survival, as compared with azacitidine alone, according to...

Myelodysplastic Syndromes

FDA Approves Oral Combination of Decitabine and Cedazuridine for Adult Patients With Myelodysplastic Syndromes

On July 7, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (Inqovi) for adult patients with myelodysplastic syndromes (MDS), including the following: Previously treated and untreated de novo and secondary MDS with the following...

Leukemia
Lymphoma
Myelodysplastic Syndromes
Symptom Management

EHA25 Virtual: Roundup of Findings in Leukemia, Lymphoma, and More

Advances in the treatment of hematologic malignancies and some of their associated symptoms were presented during EHA25 Virtual, an ongoing online conference from the European Hematology Association (EHA). Advances in the Treatment of High-Risk CLL: CLL2-GIVe Results In the CLL2-GIVe trial, the...

leukemia
myelodysplastic syndromes

Mikkael A. Sekeres, MD, on MDS, CMML, or AML: Pevonedistat and Azacitidine

Mikkael A. Sekeres, MD, of the Cleveland Clinic, discusses data from a phase II study of pevonedistat plus azacitidine vs azacitidine alone in patients with higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, or low-blast acute myeloid leukemia (Abstract 7506).

Myelodysplastic Syndromes

Luspatercept-aamt for Anemia in Adults With Myelodysplastic Syndromes

On April 3, 2020, luspatercept-aamt was approved in the treatment of anemia failing to respond to an erythropoiesis-stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks.1,2 The treatment is geared toward adult patients with very low– to intermediate-risk myelodysplastic ...

Hematologic Malignancies
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Immunotherapy

Highlights From ASH 2019 Included New Data in Leukemia, Lymphoma, Myeloma, and Myelodysplastic Syndromes

The 2019 American Society of Hematology (ASH) Annual Meeting & Exposition featured a cornucopia of sessions. It was impossible to attend all the lectures, symposia, oral presentations, poster presentations, and special events because many were concurrent. Below, we have selected some...

Myelodysplastic Syndromes

Distinct New MDS Subtype Proposed Based on Presence of Genetic Mutation

In a special report published by Malcovati et al in the journal Blood, an international working group of experts in myelodysplastic syndromes (MDS) has proposed the recognition of a distinct subtype of MDS based on the presence of a nonheritable genetic mutation that causes the disease. The...

Myelodysplastic Syndromes
Symptom Management

FDA Approves Luspatercept-aamt for Second-Line Treatment of Anemia in Adult Patients With Myelodysplastic Syndromes

On April 3, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl) for the treatment of anemia that fails to respond to an erythropoiesis-stimulating agent and requires two or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk...

Lung Cancer
Thyroid Cancer
Myelodysplastic Syndromes

FDA Pipeline: Priority Review Granted for Treatment in Lung and Thyroid Cancers

This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to a treatment for lung and thyroid cancers with a RET fusion or mutation; gave Breakthrough Therapy designation to a doublet therapy for TP53-mutated myelodysplastic syndromes; and issued an update to their...

Myelodysplastic Syndromes

Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Syndromes

In the phase III MEDALIST trial reported in The New England Journal of Medicine, Fenaux et al found that luspatercept significantly reduced the severity of anemia vs placebo in red blood cell transfusion–dependent patients with very low- to intermediate-risk myelodysplastic syndromes with ring...

Lung Cancer
Bladder Cancer
Colorectal Cancer
Hematologic Malignancies
Myelodysplastic Syndromes
Breast Cancer
Head and Neck Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in SCLC, Bladder Cancer, Colorectal Cancer

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for treatments in extensive-stage small cell lung cancer (SCLC), non–muscle invasive bladder cancer, and BRAF V600E–mutant colorectal cancer. The Agency also recently issued multiple Breakthrough Therapy designations and ...

leukemia
myelodysplastic syndromes
genomics/genetics

Ilaria Iacobucci, PhD, on AML and MDS: Moving Beyond Gene Panel–Based Classifications

Ilaria Iacobucci, PhD, of St. Jude Children’s Research Hospital, discusses her work to more accurately define mutation subtypes in acute myeloid leukemia and myelodysplastic syndromes, as well as the implications for diagnosis, prognosis, and treatment (Abstract LBA-4 ).

Leukemia
Myelodysplastic Syndromes

ASH 2019: New Genomic Mutational and Expressional Data in AML, MDS

Researchers have completed the first comprehensive analysis combining full genomic sequencing and gene-expression profiles of more than 1,300 patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The research was presented by Iacobucci et al during the 2019 American Society...

myelodysplastic syndromes
leukemia

Mikkael A. Sekeres, MD, on Newly Diagnosed Hematologic Malignancies: Early Trial Findings on Glasdegib Plus Azacitidine

Mikkael A. Sekeres, MD, of the Cleveland Clinic, discusses results of a phase Ib study of glasdegib in combination with azacitidine, which showed activity in patients with untreated myelodysplastic syndromes, acute myeloid leukemia, and chronic myelomonocytic leukemia who are ineligible for intensive chemotherapy (Abstract 177).

Myelodysplastic Syndromes

Personalized Treatment Approaches on the Horizon for Myelodysplastic Syndromes

Despite the spate of recent drug approvals in blood cancer, it’s been more than 13 years since the U.S. Food and Drug Administration (FDA) has approved a treatment for myelodysplastic syndromes (MDS), a bone marrow disorder characterized by ineffective hematopoiesis. Nevertheless, data from a...

myelodysplastic syndromes

Rafael Bejar, MD, PhD, on Myelodysplastic Syndromes: Advances in Personalized Therapeutic Approaches

Rafael Bejar, MD, PhD, of the University of California, San Diego Moores Cancer Center, discusses the tailored nature of MDS treatment, including somatic mutations that could alter treatment decisions, and novel therapies with predictive biomarkers.

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