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Leukemia
Immunotherapy

Blinatumomab in Adult and Pediatric Patients With B-Cell Precursor Acute Lymphoblastic Leukemia

EARLY IN 2018, blinatumomab (Blincyto) was granted accelerated approval for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease ≥ 0.1%.1,2 Supporting Efficacy Data APPROVAL WAS...

Leukemia

Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia

ON JULY 20, 2018, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.1,2 The FDA...

leukemia

FDA Grants Orphan Drug Designation to ASLAN003 in Acute Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) has granted ASLAN003 Orphan Drug designation as a treatment for acute myeloid leukemia (AML). ASLAN003 is an orally active, potent inhibitor of human dihydroorotate dehydrogenase (DHODH) that has the potential to be a first-in-class drug in AML. The FDA...

leukemia
immunotherapy

Bendamustine Followed by Obinutuzumab Plus Venetoclax in Treatment-Naive and Relapsed/Refractory CLL

In a German phase II trial reported in The Lancet Oncology, Cramer et al found promising response rates with bendamustine followed by obinutuzumab (Gazyva) plus venetoclax (Venclexta) in both treatment-naive and relapsed/refractory chronic lymphocytic leukemia (CLL). In the trial, patients with an ...

leukemia
issues in oncology
immunotherapy

Guidelines for Pediatric CAR T-Cell Therapy Developed

Almost 1 year after the U.S. Food and Drug Administration (FDA) approval of chimeric antigen receptor (CAR) T-cell therapy for children with acute lymphoblastic leukemia (ALL), researchers at The University of Texas MD Anderson Cancer Center and the Pediatric Acute Lung Injury and...

leukemia

FDA Grants Breakthrough Therapy Designation to Quizartinib for Relapsed/Refractory FLT3-ITD AML

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Breakthrough Therapy designation is designed to...

leukemia

Phase III ASTRAL-1 Study of Guadecitabine in Patients With Treatment-Naive AML Ineligible to Receive Intensive Induction Chemotherapy

Results were recently announced from the ASTRAL-1 study evaluating the efficacy and safety of guadecitabine in adults with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive induction chemotherapy. The study did not meet its co-primary endpoints: complete...

leukemia

Treatment Intensification for Childhood B-Cell Lymphoblastic Leukemia With IKZF1 Deletion

In an analysis of Asian trials reported in the Journal of Clinical Oncology, Yeoh et al found evidence that treatment intensification improved outcomes in childhood B-cell acute lymphoblastic leukemia (B-ALL) with IKZF1 deletion (del). The analysis compared outcomes in the Malaysia-Singapore ALL...

Hematologic Malignancies
Leukemia
Immunotherapy

FDA Approves Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia

On July 20, 2018, the U.S. Food and Drug Administration approved ivosidenib (Tibsovo) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Approval was based on an open-label, single-arm, multicenter...

leukemia

CPX-351 Liposome in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia

In a pivotal phase III trial reported in the Journal of Clinical Oncology, Lancet et al found that cytarabine and daunorubicin liposome (CPX-351, Vyxeos) significantly improved overall survival vs standard cytarabine plus daunorubicin (7+3 regimen) in older patients with newly diagnosed secondary...

leukemia

Susan M. O’Brien, MD, on CLL: Sequencing Therapy Options

Susan M. O’Brien, MD, of the University of California, Irvine, discusses three oral agents for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma, and the use of chemotherapy for the disease.

leukemia

Second Allogeneic HCT vs Donor Lymphocyte Infusion in Acute Myeloid Leukemia Relapse

In a retrospective registry study reported in JAMA Oncology, Kharfan-Dabaja et al found no overall survival difference with second allogeneic hematopoietic cell transplantation (HCT) vs donor lymphocyte infusion (DLI) in patients with acute myeloid leukemia (AML) relapse. The study involved 418...

leukemia

FDA Approves Ivosidenib for IDH1-Mutated AML

Today, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (isocitrate dehydrogenase-1 [IDH1]...

Hematologic Malignancies
Leukemia

NCCN Releases New Guidelines for Patients With AML

The National Comprehensive Cancer Network® (NCCN®) has recently released The NCCN Guidelines for Patients with Acute Myeloid Leukemia (AML), which includes resources for better-informed medical decision-making. The NCCN Guidelines for Patients with AML is endorsed by the Aplastic Anemia and MDS...

Leukemia

Expert Point of View: Susan O'Brien, MD, and Bruce Cheson, MD

SUSAN O’BRIEN, MD, Associate Director for Clinical Science, Chao Family Comprehensive Cancer Center, University of California Irvine Health, told The ASCO Post that the pairing of ibrutinib (Imbruvica) and venetoclax (Venclexta) “is clearly a very powerful combination.” The next question, she...

Leukemia

Ibrutinib Plus Venetoclax in CLL: High MRD-Negativity Rates, Reduced Risk for Tumor-Lysis Syndrome

A REGIMEN COMBINING ibrutinib (Imbruvica) and venetoclax (Venclexta) in previously untreated patients with chronic lymphocytic leukemia (CLL) greatly reduced the risk of venetoclax-associated tumor-lysis syndrome and led to promising rates of undetectable minimal residual disease (MRD) in the phase ...

leukemia

FDA Grants Priority Review for Glasdegib in Patients With Previously Untreated AML

The U.S. Food and Drug Administration (FDA) recently accepted a new drug application and granted Priority Review designation for glasdegib, an investigational oral smoothened inhibitor being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in...

Leukemia
Immunotherapy

Outcomes of Tisagenlecleucel Therapy in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia

As reported in The New England Journal of Medicine by Shannon L. Maude, MD, PhD, of Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, the phase II ELIANA trial has shown that the anti-CD19 chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) ...

leukemia

Long-Term Outcomes With Dasatinib Plus Intensive Chemotherapy in Pediatric/Young Adult Ph-Positive ALL

In an analysis of the Children’s Oncology Group (COG) AALL0622 trial reported in the Journal of Clinical Oncology, Slayton et al found that adding dasatinib (Sprycel) to intensive chemotherapy produced good long-term outcomes in pediatric/young adult patients with newly diagnosed Philadelphia ...

leukemia

Quizartinib in Relapsed or Refractory AML

In a phase II trial reported in The Lancet Oncology, Cortes et al found that the next-generation FLT3 inhibitor quizartinib had good activity in patients with relapsed or refractory acute myeloid leukemia (AML), with greater activity in patients with FLT3-ITD mutations. Study Details The study...

leukemia

Suboptimal Use of Initial Chemotherapy in Newly Diagnosed AML

In a study of National Cancer Database data reported in Blood Advances, Bhatt et al found that 25% of patients with newly diagnosed acute myeloid leukemia (AML) did not receive initial chemotherapy, despite evidence that chemotherapy is associated with a survival benefit and improvement in symptoms ...

Leukemia

Patients With AML Have Reduced Risk of Early Mortality at NCI-Designated Cancer Centers

RESEARCHERS AT the University of California (UC), Davis, have shown that patients with acute myeloid leukemia (AML) who received their care at a National Cancer Institute (NCI) cancer center in California had a dramatically reduced risk of early mortality. Using data from the California Cancer...

leukemia

Activity of Ivosidenib in IDH1-Mutated Relapsed or Refractory Acute Myeloid Leukemia

As reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine by DiNardo et al, early-phase testing has shown activity of ivosidenib, an oral small-molecule inhibitor of mutant IDH1, in patients with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML). IDH1...

Hematologic Malignancies
Leukemia

Phase I Study Shows Safety, Efficacy of Ivosidenib in Acute Myeloid Leukemia

Ivosidenib, an isocitrate dehydrogenase-1 (IDH1) inhibitor, yielded durable and molecular remissions in some patients with IDH1-mutated advanced relapsed or refractory acute myeloid leukemia (AML). At a dose of 500 mg/d, ivosidenib was associated with a low frequency of grade 3 or higher...

Hematologic Malignancies
Leukemia

Minimal Residual Disease Testing in AML: Still a Shifting Target

Testing for minimal residual disease (MRD) has become an established part of the management of acute lymphoblastic leukemia (ALL), but in acute myeloid leukemia (AML), the technology still warrants validation. To address issues and set new standards, the European LeukemiaNet Working Party recently ...

leukemia

EHA 2018: Single-Agent Quizartinib vs Chemotherapy in Relapsed or Refractory AML

Results from the phase III QuANTUM-R study of single-agent quizartinib in relapsed or refractory acute myeloid leukemia (AML) were presented by Cortes et al at the 23rd Annual Congress of the European Hematology Association (EHA) (Abstract LB2600). Study Findings QuANTUM-R study results showed...

leukemia

EHA 2018: Undetectable MRD Rates With Venetoclax Plus Rituximab in Relapsed or Refractory CLL

Investigational data from a new analysis of undetectable minimal residual disease (MRD) rates from the phase III MURANO trial of venetoclax (Venclexta, a first-in-class oral B-cell lymphoma 2 [BCL2] inhibitor) in combination with rituximab (Rituxan) in patients with relapsed or refractory chronic...

leukemia
immunotherapy

EHA 2018: Obinutuzumab or Rituximab Plus Chlorambucil in CLL

Data from the final analysis of the CLL11 study evaluating obinutuzumab (Gazyva)-based treatment in previously untreated chronic lymphocytic leukemia (CLL) was presented by Goede et al during the Presidential Symposium at the 23rd Annual Congress of the European Hematology Association (EHA)...

leukemia

EHA 2018: Alvocidib in Patients With Relapsed or Refractory MCL-1–Dependent AML

Preliminary data from Zella 201—an ongoing phase II study evaluating the efficacy and safety of alvocidib, a potent cyclin-dependent kinase 9 (CDK9) inhibitor, in combination with cytarabine and mitoxantrone in patients with relapsed or refractory MCL-1–dependent acute myeloid leukemia...

leukemia
lymphoma
immunotherapy

iLLUMINATE Trial of Ibrutinib Plus Obinutuzumab for First-Line Therapy of CLL/SLL Meets Primary Endpoint

The phase III iLLUMINATE (PCYC-1130) trial recently met its primary endpoint of improvement in progression-free survival. The study evaluated ibrutinib (Imbruvica) in combination with obinutuzumab (Gazyva) in patients with previously untreated chronic lymphocytic leukemia or small lymphocytic...

leukemia
lymphoma
immunotherapy

Rapid Progression of Adult T-Cell Leukemia/Lymphoma During PD-1 Inhibitor Therapy

In a letter to the editor in The New England Journal of Medicine, Ratner et al describe rapid progression of adult T-cell leukemia/lymphoma (ATLL) in three consecutive patients receiving programmed cell death protein 1 (PD-1) inhibitor therapy with nivolumab (Opdivo). As stated by the authors,...

Lymphoma
Leukemia

Adherence to Oral Anticancer Treatment: Priorities in Lymphoma and CLL

ADVANCES IN cancer treatment have been nothing short of breathtaking in recent years. Among the most important has been the advent of effective oral therapies, marking a significant change in the way many patients receive treatment and in the oversight required by the cancer care team. As with...

leukemia
lymphoma

FDA Approves Second-Line Venetoclax for CLL or SLL With or Without 17p Deletion

On June 8, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. MURANO Approval was based ...

leukemia
geriatric oncology

Courtney Denton Dinardo, MD, on AML: Treatment Study Results

Courtney Denton Dinardo, MD, of The University of Texas MD Anderson Cancer Center, discusses findings on the durable response with venetoclax in combination with decitabine or azacitidine in elderly patients with acute myeloid leukemia (Abstract 7010).

leukemia
immunotherapy

Peter Hillmen, MB, ChB, on CLL: Results From the MURANO Trial

Peter Hillmen, MB, ChB, of St James’s University Hospital, discusses phase III study findings on minimal residual disease negativity with venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukemia (Abstract 7508).

leukemia

William G. Wierda, MD, PhD, and Julie M. Vose, MD, MBA, on CLL: Results From the CAPTIVATE Trial

Julie M. Vose, MD, MBA, of the University of Nebraska Medical Center, and William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discuss phase II findings on ibrutinib plus venetoclax in first-line treatment of chronic lymphocytic leukemia (Abstract 7502).

leukemia

Rita Elias Assi, MD, on AML and Genomics

Rita Elias Assi, MD, of The University of Texas MD Anderson Cancer Center, discusses the impact of next-generation sequencing on treatment selection in acute myeloid leukemia (Abstract 103).

leukemia

Robert J. Kreitman, MD, on Hairy Cell Leukemia: Results From an International Study

Robert J. Kreitman, MD, of the National Cancer Institute, discusses findings on moxetumomab pasudotox in heavily pretreated patients with relapsed or refractory hairy cell leukemia (Abstract 7004).

leukemia

FDA Grants Priority Review to Gilteritinib for the Treatment of Relapsed or Refractory FLT3 Mutation–Positive AML

The U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, a new drug application (NDA) for gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) and a mutation in the FLT3 gene, as detected by an FDA-approved test....

Leukemia

Molecular Minimal Residual Disease Detection Shows Further Promise in Acute Myeloid Leukemia

Extended next-generation sequencing genomic profiling in acute myeloid leukemia (AML) has revealed remarkable heterogeneity and molecular complexity of the disease and provided critical insights into the genetic mechanisms underpinning of preleukemic and leukemic pathogenesis.1,2 Despite...

Leukemia

Targeted Sequencing Detection of Molecular Minimal Residual Disease and Prognosis in Acute Myeloid Leukemia

In a study reported in The New England Journal of Medicine, Mojca Jongen-Lavrencic, MD, PhD, of Erasmus MC Cancer Institute, and colleagues found that molecular minimal residual disease identified by next-generation sequencing during complete remission was associated with an increased risk of...

Colorectal Cancer
Breast Cancer
Hepatobiliary Cancer
Lung Cancer
Kidney Cancer
Prostate Cancer
CNS Cancers
Leukemia

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2018 Guidelines Updates

In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®) covering 8 tumor types. Guidelines are now published for more than 60 tumor types and topics. Some of the key updates were presented at NCCN’s 23rd...

leukemia

Outcomes After Discontinuation of Tyrosine Kinase Inhibitor Therapy in Chronic Myeloid Leukemia

In an interim analysis of a European trial reported in The Lancet Oncology, Saussele et al found that discontinuation of tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia (CML) with deep molecular response was associated with good molecular relapse-free survival,...

leukemia

Clearance of Somatic Mutations at Remission and Outcomes in AML

In a study reported in the Journal of Clinical Oncology, Morita et al found that clearance of somatic mutations at complete remission—particularly those in nonpreleukemic genes—was associated with improved outcomes in previously untreated patients with acute myeloid leukemia (AML)....

Leukemia
Genomics/Genetics

Minimal Residual Disease in Acute Myeloid Leukemia: Mutation Matters

A RECENT article in The New England Journal of Medicine explored the nuances of minimal/measurable residual disease testing after induction treatment of acute myeloid leukemia (AML)1 and David P. Steensma, MD, and Benjamin L. Ebert, MD, PhD, of Dana-Farber Cancer Institute and Harvard Medical...

leukemia

Results From the Full Population of a Phase II Trial of Venetoclax in CLL With 17p Deletion

In an article published in the Journal of Clinical Oncology, Stilgenbauer et al reported findings from the full population of the phase II trial that supported the 2016 approval of venetoclax (Venclexta) in the treatment of previously treated chronic lymphocytic leukemia (CLL) with 17p deletion....

Hematologic Malignancies
Leukemia

Nilotinib Label Updated to Provide Treatment Discontinuation Recommendations for CML With Sustained Molecular Response

On December 22, 2017, the product label for nilotinib (Tasigna) was updated to include information on nilotinib discontinuation, postdiscontinuation monitoring, and guidance for treatment reinitiation in patients with Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) who have...

leukemia

Pediatric Centers May Improve Survival for Adolescents and Young Adults With ALL

Adolescents and young adults (AYAs) with acute lymphocytic leukemia (ALL) have a survival advantage if they receive treatment at a pediatric cancer center vs an adult center, according to a study published by Muffly et al in Blood Advances. The findings also suggest that treatment at a center...

Hematologic Malignancies
Leukemia
Immunotherapy

Fine-Tuning Treatment in Myeloma and Leukemia

It is a difficult task to include every notable presentation from the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition. In addition to our more comprehensive coverage of the news from that meeting over the past several issues, below are summaries of additional key...

leukemia

Minimal Residual Disease and Risk Stratification in Acute Myeloid Leukemia

In an analysis of the UK National Cancer Research Institute AML17 trial reported in the Journal of Clinical Oncology, Freeman et al found that detection of measureable/minimal residual disease (MRD) after first induction in acute myeloid leukemia (AML) may be prognostically equivalent to partial...

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