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Issues in Oncology
Immunotherapy
Hematologic Malignancies
Leukemia

CAR T-Cell Therapy for CLL

A pair of new studies from researchers at the Abramson Cancer Center of the University of Pennsylvania are shedding light on why patients with advanced chronic lymphocytic leukemia (CLL) respond or do not respond to chimeric antigen receptor (CAR) T-cell therapy. Although CAR T-cell therapy is...

Hematologic Malignancies
Leukemia

Durable Responses With Moxetumomab Pasudotox in Pretreated Hairy Cell Leukemia

Moxetumomab pasudotox produced deep and durable responses in a heavily pretreated population of patients with hairy cell leukemia, with the ability to eradicate minimal residual disease. The drug showed a favorable safety profile with less bone marrow suppression than with purine nucleoside analog...

Hematologic Malignancies
Leukemia

Durable Response With Venetoclax and Azacitidine in Elderly Patients With AML

In elderly patients with untreated acute myeloid leukemia (AML), venetoclax (Venclexta), given at a 400-mg dose, with an azacitidine backbone led to durable responses with a tolerable safety profile, according to data from a phase Ib dose-escalation and -expansion study. Response rates were high...

leukemia

Childhood Nonlymphoid Leukemia Risk With Maternal Use of Hormonal Contraception

In a population-based cohort study reported in The Lancet Oncology, Hargreave et al found that recent maternal use of hormonal contraception was associated with increased risk of childhood nonlymphoid leukemia.   Study Details The study involved data from a nationwide cohort of...

leukemia

Neonatal Dysregulated Immune Function and Pediatric B-Cell Precursor ALL

A high incidence of clinically diagnosed infections in the first year of life among children who later developed acute lymphoblastic leukemia (ALL) has led researchers to propose that children with ALL are born with a dysregulated immune function, resulting in a more vigorous reaction to infections ...

leukemia

FDA Approves Moxetumomab Pasudotox-tdfk for the Treatment of Hairy Cell Leukemia

The U.S. Food and Drug Administration (FDA) today approved moxetumomab pasudotox-tdfk (Lumoxiti) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with...

leukemia
symptom management

Study Finds Hispanic Pediatric Patients at Increased Risk of Methotrexate Neurotoxicity During Treatment for ALL

Case studies have reported a high prevalence of methotrexate subacute neurotoxicity among Hispanic adolescents with acute lymphoblastic leukemia (ALL), suggesting sensitivity to methotrexate therapy may differ by race and ethnicity. Now, a prospective study in pediatric patients with ALL has found...

Leukemia

Suboptimal Use of Initial Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia

IN A STUDY of National Cancer Database data reported in Blood Advances, Vijaya Raj Bhatt, MD, of the University of Nebraska Medical Center, and colleagues found that 25% of patients with newly diagnosed acute myeloid leukemia (AML) did not receive initial chemotherapy, despite evidence that...

Hematologic Malignancies
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, Francois-Xavier Mahon, MD, of Institut Bergonié, Bordeaux, and colleagues found that discontinuation of tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia (CML) with deep molecular response was...

leukemia

Comparison of Methotrexate Intensification Regimens in Children and Young Adults With T-Cell ALL

As reported by Winter et al in the Journal of Clinical Oncology, findings in the Children’s Oncology Group (COG) AALL0434 trial indicate improved outcomes with a COG methotrexate intensification regimen vs a high-dose methotrexate intensification regimen in children and young adults with...

leukemia

FDA Accepts sBLA for Dasatinib in Pediatric Patients With Newly Diagnosed Ph-Positive ALL

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia...

leukemia
lymphoma
immunotherapy

CAR T-Cell Therapy in Europe: Differing Decisions on Approval of Two Agents

The European Commission (EC) recently approved the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) in the European Union (EU) for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is...

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).

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