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Leukemia
Immunotherapy

Expert Point of View: Howard J. Weinstein, MD

Commenting on the blinatumomab study, Howard J. Weinstein, MD, Chief of Pediatric Hematology-Oncology at Massachusetts General Hospital for Children and Harvard Medical School in Boston, said: “These are very promising results for children, adolescents, and young adults who have had a first...

Leukemia

Selected Abstracts on Novel Therapies for Chronic Myeloid Leukemia

To complement The ASCO Post’s comprehensive coverage of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic regimens for chronic myeloid leukemia (CML). For full details of...

Immunotherapy
Leukemia

Blinatumomab Outperforms Chemotherapy as Post-Reinduction Consolidation Therapy in Younger Patients With B-Cell ALL

Blinatumomab was superior to standard chemotherapy in children, adolescents, and young adults at the first relapse of B-cell acute lymphoblastic leukemia (ALL) as post-reinduction consolidation therapy prior to hematopoietic stem cell transplant (HSCT), according to the results of a late-breaking...

Leukemia

ADMIRAL Trial: Gilteritinib Improves Overall Survival in Relapsed or Refractory FLT3-Mutated AML

As reported in The New England Journal of Medicine by Alexander E. Perl, MD, of Abramson Cancer Center, University of Pennsylvania, and colleagues, the phase III ADMIRAL trial showed improved overall survival with the oral FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib vs salvage...

Leukemia

Activity of Ruxolitinib in Chronic Neutrophilic Leukemia and Atypical Chronic Myeloid Leukemia

In a phase II study reported in the Journal of Clinical Oncology, Dao et al found that the JAK1/2 inhibitor ruxolitinib was active in patients with chronic neutrophilic leukemia (CNL), with less activity observed in those with atypical chronic myeloid leukemia (CML) and greater activity observed...

Leukemia

Asciminib for Patients With CML After Failure of ABL Kinase Inhibitor Treatment

In a phase I trial reported in The New England Journal of Medicine, Hughes et al found that asciminib, an oral BCR-ABL1 inhibitor with a mechanism of action different from available ABL1 tyrosine kinase inhibitors, was active in patients with chronic myeloid leukemia (CML) after failure of ABL...

Leukemia
Immunotherapy

Fractionated Tisagenlecleucel Infusion for Adults With B-Cell Acute Lymphoblastic Leukemia May Improve Safety Without Reducing Efficacy

As reported by Noelle V. Frey, MD, and colleagues in the Journal of Clinical Oncology, single-center experience with the anti-CD19 chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel has shown that high-dose fractionated infusion with the ability to modify dosing in case of early signs...

Leukemia

Gilteritinib for Relapsed or Refractory AML With FLT3 Mutation

Late in 2018, the FLT3 inhibitor gilteritinib was approved for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA also approved an expanded indication...

Leukemia

Selected Abstracts From the 2019 ASH Annual Meeting & Exposition

To complement The ASCO Post’s comprehensive coverage of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic regimens for acute myeloid leukemia (AML). For full details of these...

Lymphoma
Leukemia

Acalabrutinib for Adult Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

On November 21, 2019, the Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib was approved for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 The review resulting in approval was conducted under Project Orbis, an initiative of the U.S....

Leukemia
Symptom Management

Risk of Asparaginase-Associated Pancreatitis in Patients With Acute Lymphoblastic Leukemia

In a study reported in the Journal of Clinical Oncology, Rank et al found a similar risk of asparaginase-associated pancreatitis in older children, adolescents, and adults and greater associated morbidity in adolescents with acute lymphoblastic leukemia treated according to the Nordic Society of...

leukemia
immunotherapy

Jeff P. Sharman, MD, on CLL: Trial Results on Acalabrutinib, Obinutuzumab, and Chlorambucil

Jeff P. Sharman, MD, of the Willamette Valley Cancer Institute and US Oncology Research, discusses phase III findings from the ELEVATE TN study, which showed that acalabrutinib plus obinutuzumab and acalabrutinib monotherapy improved progression-free survival in patients with treatment-naive chronic lymphocytic leukemia (Abstract 31).

leukemia
immunotherapy

Patrick A. Brown, MD, on B-Cell ALL in Children, Adolescents, and Young Adults: Blinatumomab vs Chemotherapy

Patrick A. Brown, MD, of Johns Hopkins University, discusses phase III findings from a Children’s Oncology Group Study showing that blinatumomab was superior to chemotherapy in terms of efficacy and tolerability for young patients as a post-reinduction therapy in the setting of high- and intermediate-risk first relapse of B-cell acute lymphoblastic leukemia (Abstract LBA-1).

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

Jerald P. Radich, MD, on CML: Predicting Deep Molecular Response to Treatment

Jerald P. Radich, MD, of the Fred Hutchinson Cancer Research Center, discusses a gene-expression model that distinguishes patients with chronic myeloid leukemia who achieved a deep molecular response from those with a poor response to treatment. This work could yield new therapeutic targets that could potentially turn a poor responder into a good responder who might even achieve treatment-free remission (Abstract 665).

leukemia

Andrew H. Wei, MBBS, PhD, on AML: Results From the QUAZAR Trial on Oral Azacitidine

Andrew H. Wei, MBBS, PhD, of The Alfred Hospital, Melbourne, discusses phase III findings on oral azacitidine (CC-486), the first treatment used in the maintenance setting shown to improve both overall and disease-free survival in patients with acute myeloid leukemia that is in remission following induction chemotherapy (Abstract LBA-3).

leukemia
lymphoma

Jennifer Crombie, MD, on Relapsed or Refractory CLL/SLL: Results From a Phase I Trial of Duvelisib and Venetoclax

Jennifer Crombie, MD, of Dana-Farber Cancer Institute, discusses early study results which showed that duvelisib plus venetoclax showed activity in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, with no dose-limiting toxicities observed (Abstract 1763).

Leukemia
Immunotherapy

ASH 2019: Blinatumomab vs Standard Chemotherapy for Pediatric Patients With Relapsed B-ALL

Blinatumomab improved survival in children with relapsed B-acute lymphoblastic leukemia (B-ALL) compared with standard chemotherapy, accordings to findings from a study presented by Brown et al at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract LBA-1)....

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...

Leukemia

ASH 2019: Oral Azacitidine Improves Survival in Older Patients With AML in First Remission

Treatment with an investigational oral form of azacitidine, CC-486, improved overall survival in older patients with newly diagnosed acute myeloid leukemia (AML) who were in remission following standard induction chemotherapy with or without consolidation therapy, according to a phase III study...

Leukemia
Issues in Oncology

ASH 2019: Should African American Patients With AML and Evidence of Abnormal Kidney Function Be Enrolled Into Clinical Trials?

A study of more than 1,000 patients with acute myeloid leukemia (AML) revealed that African Americans were more likely to have evidence of abnormal kidney functioning than whites, but this was not associated with any difference in overall survival. The findings, presented by Statler et al at the...

Leukemia
Genomics/Genetics

ASH 2019: Genomic Features of AML in Patients Aged 60 or Older May Predict Stem Cell Transplant Outcome

For older patients with acute myeloid leukemia (AML), the prospects for success of a stem cell transplant can often be predicted based on the particular set of leukemic genetic characteristics, according to results presented by Murdock et al at the 2019 American Society of Hematology (ASH) Annual...

leukemia

Tait D. Shanafelt, MD, on CLL in Younger Patients: Comparing Ibrutinib and Rituximab With FCR

Tait D. Shanafelt, MD, of Stanford University, discusses extended follow-up data that show ibrutinib plus rituximab improved clinical outcomes vs the standard therapy of fludarabine/cyclophosphamide/ rituximab in younger patients with previously untreated chronic lymphocytic leukemia (Abstract 33).

leukemia

Mhairi Copland, PhD, MB BChir, on Blast Phase CML: A Possible Treatment Advance

Mhairi Copland, PhD, MB BChir, of the University of Glasgow, discusses results of a study on the combination of ponatinib and fludarabine, cytarabine, idarubicin, and G-CSF for patients with blast phase chronic myeloid leukemia, a rare complication with a poor outcome (Abstract 497).

leukemia

Nitin Jain, MD, on First-Line Ibrutinib Plus Venetoclax in CLL

Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses findings from two studies showing that the combination of ibrutinib and venetoclax is an effective chemotherapy-free oral regimen for patients with high-risk, previously untreated chronic lymphocytic leukemia (Abstract 34).

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).

Leukemia
Issues in Oncology

ASH 2019: Lower Area-Based Income and Educational Attainment Associated With Poorer Survival Among Pediatric Patients With AML

Children from lower-income neighborhoods were 2.4 times more likely to die during treatment for acute myeloid leukemia (AML) than children from middle- and high-income neighborhoods, according to findings from a study that analyzed nearly 1,500 clinical trial participants. While previous research...

Leukemia

Calaspargase Pegol-mknl for Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia

In late 2018, calaspargase pegol-mknl, an asparagine-specific enzyme, was approved for use as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to 21 years.1,2 The new product provides for a longer interval ...

Leukemia

Glasdegib in Older Patients With AML or Those With Comorbidities

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Late in 2018, the Hedgehog pathway inhibitor glasdegib...

Leukemia
Lymphoma

FDA Approves Acalabrutinib for CLL/SLL as Part of Project Orbis

On November 21, as part of Project Orbis—a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada—the U.S. Food and Drug Administration (FDA) granted supplemental approval to acalabrutinib (Calquence) for the treatment of adults with chronic lymphocytic leukemia...

Leukemia

Late Bone Marrow Relapse Risk Stratification in Pediatric Patients With B-Cell Acute Lymphoblastic Leukemia

In an analysis of the German ALL-REZ BFM 2002 trial, reported in the Journal of Clinical Oncology, Eckert et al found that postinduction minimal residual disease (MRD)-based treatment stratification resulted in “excellent survival” in pediatric patients with late relapse of B-cell precursor acute...

Issues in Oncology
Hematologic Malignancies
Leukemia

How Clonal Hematopoiesis of Indeterminate Potential Increases the Risk of Heart Disease and Blood Cancers as People Age

Although stem cells throughout the body acquire genetic mutations over time, usually these alterations do not affect how the stem cells function or cause disease. However, recent research in clonal hematopoiesis and aging has found an association between clonal expansion of hematopoietic cells with ...

Leukemia
Lymphoma

Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

On May 15, 2019, venetoclax was approved for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 Supporting Efficacy Data Approval was based on findings from the open-label phase III CLL14 trial (ClinicalTrials.gov...

Leukemia

ADMIRAL: Gilteritinib vs Chemotherapy in Relapsed or Refractory FLT3-Mutated AML

As reported in The New England Journal of Medicine by Perl et al, the phase III ADMIRAL trial showed improved overall survival with the oral FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib vs salvage chemotherapy in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia...

Leukemia

Asciminib/Imatinib in Patients With Previously Treated CML

In a phase I trial, the combination of the BCR-ABL1 inhibitor asciminib and the small-molecule kinase inhibitor imatinib showed preliminary efficacy, safety, and tolerability in patients with chronic myeloid leukemia (CML) resistant to or intolerant of treatment with two or more prior tyrosine...

Breast Cancer
Leukemia
Prostate Cancer
Lymphoma

FDA Pipeline: Treatments for HER2-Positive Breast Cancer, AML; Breakthrough Device for Prostate Cancer; Statement on Safety Information for Breast Implants

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to trastuzumab deruxtecan for the treatment of HER2-positive metastatic breast cancer; granted Fast Track designation for bemcentinib for elderly patients with relapsed acute myeloid leukemia (AML); granted Breakthrough...

Leukemia
Genomics/Genetics
Immunotherapy

Gene Signature to Identify Benefit of Front-Line Fludarabine, Cyclophosphamide, and Rituximab in IGHV-Unmutated CLL

In a retrospective cohort study reported in The Lancet Oncology, Herling et al identified a 17-gene signature that distinguished patients with IGHV-unmutated chronic lymphocytic leukemia (CLL) more likely to achieve long-term remission after front-line chemoimmunotherapy with fludarabine,...

Immunotherapy
Leukemia

Debating the Role of Chemoimmunotherapy in the First-Line Setting of CLL

The advent of new targeted agents for chronic lymphocytic leukemia (CLL) has ushered in a golden age of treatment, leading to longer, more durable periods of disease control. Not all oncologists are convinced, however, that improvements in progression-free survival alone warrant dispensing with...

leukemia
immunotherapy

Nitin Jain, MD, on CLL: Is There a Role for Chemoimmunotherapy?

Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses the debate on evolving strategies in first-line treatment of CLL.

leukemia
immunotherapy

William G. Wierda, MD, PhD, on Evolving Strategies for First-Line Treatment of CLL

William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, offers commentary on the debate about evolving strategies in first-line chronic lymphocytic leukemia, the clinical trials on such agents as ibrutinib, BTK inhibitors, and venetoclax, and the interest in chemoimmunotherapy as a fixed duration treatment.

Prostate Cancer
Bladder Cancer
Hematologic Malignancies
Breast Cancer
CNS Cancers
Leukemia
Skin Cancer

FDA Pipeline: Advances in Prostate Cancer, Urothelial Cancer, Myelofibrosis, and More

In the past few weeks, the U.S. Food and Drug Administration (FDA) has issued regulatory decisions in prostate cancer, urothelial cancer, myelofibrosis, breast cancer, pediatric brain cancer, leukemia, and skin cancer. Breakthrough Therapy Designation for Niraparib in Metastatic...

Leukemia

SOHO 2019: Asciminib/Imatinib in Patients With Previously Treated CML

In a phase I trial, the combination of the BCR-ABL1 inhibitor asciminib and the small-molecule kinase inhibitor imatinib showed preliminary efficacy, safety, and tolerability in patients with chronic myeloid leukemia (CML) resistant to or intolerant of treatment with two or more prior tyrosine...

Leukemia

Having Cancer as a Teenager Derailed My Life Course

In 1994, I was a normal, active 15-year-old, who loved cars, sports, and rock music, especially songs from my favorite group, The Clash. In fact, it was while jubilantly dancing alone in my room to one of their tunes that I vomited into my hands, an early symptom of acute myeloid leukemia (AML). I...

Myelodysplastic Syndromes
Leukemia
Lung Cancer
Solid Tumors
Colorectal Cancer
Hepatobiliary Cancer

FDA Pipeline: Fast Track Designation in Myelodysplastic Syndrome and AML, Plus Multiple Breakthrough Designations

Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to magrolimab in myelodysplastic syndrome and acute myeloid leukemia (AML). The agency also granted Breakthrough Therapy designations in lung cancer and desmoid tumors, as well as Breakthrough Device designations...

Leukemia
Survivorship

Risk of Infections in Survivors of Childhood Leukemia

In a study reported in the Journal of Clinical Oncology, Pelland-Marcotte et al found that survivors of childhood leukemia remained at significantly increased risk of infection compared with matched controls during an extended period following completion of treatment.   Study Details The...

Genomics/Genetics
Leukemia

Chromosomal Abnormalities and Prognosis in NPM1-Mutant AML

In a study reported in the Journal of Clinical Oncology, Angenendt et al found that adverse-risk cytogenetics were associated with significantly poorer outcomes vs normal karyotype among patients with acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation. As stated by the...

leukemia
prostate cancer
gastrointestinal cancer

FDA Pipeline: Designation in CLL, New Drug Application in GIST, New Prostate Ablation System Receives 510(k) Clearance

Recently, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to acalabrutinib in chronic lymphocytic leukemia (CLL), accepted a new drug application for avapritinib in some types of gastrointestinal stromal tumors (GIST), and granted 501(k) clearance to market the...

leukemia
immunotherapy

Ibrutinib/Rituximab vs Standard Chemoimmunotherapy in Previously Untreated CLL

In an interim analysis of the phase III E1912 trial reported in The New England Journal of Medicine, Shanafelt et al found that ibrutinib/rituximab improved progression-free and overall survival vs standard chemoimmunotherapy in patients 70 years old or younger with previously untreated chronic...

leukemia
lung cancer
sarcoma
immunotherapy

FDA Pipeline: Label Update for Durvalumab in NSCLC; Applications Accepted in Epithelioid Sarcoma, AML

Recently, the U.S. Food and Drug Administration (FDA) approved the inclusion of overall survival from the PACIFIC trial in the U.S. prescribing information for durvalumab and accepted applications for a new drug in the treatment of epithelioid sarcoma and two orphan drugs in the treatment of acute...

Hematologic Malignancies
Leukemia

Active Regimen for High-Risk and Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

In a single-center phase II trial reported in The New England Journal of Medicine, Nitin Jain, MD, and colleagues found that the combination of ibrutinib and venetoclax was highly active in previously untreated high-risk and older patients with chronic lymphocytic leukemia (CLL).  In the study, 80 ...

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