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Ann-Kathrin Eisfeld, MD, on AML in Black Patients: Racial Disparities in Survival Outcomes
Ann-Kathrin Eisfeld, MD, of The Ohio State University Comprehensive Cancer Center, discusses SEER data showing that patients with acute myeloid leukemia who are Black and younger than age 60 may have poor survival outcomes, a disparity that should be addressed and further studied to establish...
Andrew H. Wei, MBBS, PhD, on AML: Venetoclax Plus Cytarabine in Older Patients
Andrew H. Wei, MBBS, PhD, of The Alfred Hospital, Monash University, discusses phase III data from the VIALE-C trial, which appear to support the use of venetoclax plus low-dose cytarabine as a front-line treatment for older patients with acute myeloid leukemia, as well as for those who cannot...
Arnon P. Kater, MD, PhD, on CLL: Efficacy of Venetoclax in Relapsed or Refractory Disease
Arnon P. Kater, MD, PhD, of the University of Amsterdam, Cancer Center Amsterdam, discusses phase IIIb results from the VENICE I trial, which confirmed that venetoclax monotherapy can achieve deep responses and has a tolerable and manageable safety profile in patients with relapsed or refractory...
Jorge E. Cortes, MD, on Chronic Phase CML: Comparing Three Starting Doses of Ponatinib
Jorge E. Cortes, MD, of Georgia Cancer Center, discusses interim results from the OPTIC study, which showed a trend toward dose-dependent efficacy and safety, and may provide a refined understanding of the ponatinib benefit/risk profile and its relation to dose. Mature data from continued follow-up ...
John C. Byrd, MD, on CLL/SLL: Acalabrutinib in Treatment-Naive Patients
John C. Byrd, MD, of The Ohio State University Comprehensive Cancer Center, discusses the mature results of a phase II study showing durable remissions and long-term tolerability of acalabrutinib in treatment-naive patients with relapsed or refractory chronic lymphocytic leukemia or small...
Anthony Moorman, PhD, on ALL: Improving Outcomes With a Tyrosine Kinase Inhibitor Plus Chemotherapy
Anthony Moorman, PhD, of Newcastle University, discusses preliminary data showing high-risk patients with acute lymphoblastic leukemia and ABL-class mutations may have improved outcomes when a tyrosine kinase inhibitor is added to chemotherapy (Abstract S117).
Farhad Ravandi-Kashani, MD, on Acute Myeloid Leukemia: AMG 330 in Patients With Relapsed or Refractory Disease
Farhad Ravandi-Kashani, MD, of The University of Texas MD Anderson Cancer Center, discusses updates from a phase I dose-escalation study of AMG 330, a bispecific T-cell engager molecule. It showed early evidence of an acceptable safety profile, drug tolerability, and antileukemic activity,...
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).
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...
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...
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).
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).
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...
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.
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...
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...
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...
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...
FDA Approves Rituximab Biosimilar for Non-Hodgkin Lymphoma, CLL, and Autoimmune Conditions
Today, the U.S. Food and Drug Administration (FDA) approved rituximab-pvvr (Ruxience), a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis and microscopic polyangiitis....
CLARITY: Ibrutinib Plus Venetoclax in Relapsed or Refractory Chronic Lymphocytic Leukemia
In the phase II CLARITY trial reported in the Journal of Clinical Oncology, Hillmen et al found that the combination of ibrutinib and venetoclax resulted in high rates of minimal residual disease eradication in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In the...
Anesthesia Exposure and Neurocognitive and Neuroimaging Outcomes in Long-Term Survivors of Childhood ALL
In a study reported in JAMA Oncology, Banerjee et al found that higher cumulative anesthesia exposure and duration of exposure during treatment of childhood acute lymphoblastic leukemia (ALL) may be associated with adverse neurocognitive and abnormal neuroimaging outcomes in long-term survivors....
Substitution of Clofarabine for Anthracycline/Etoposide in Induction Therapy for Pediatric Acute Myeloid Leukemia
In the phase III AML08 trial reported in the Journal of Clinical Oncology, Rubnitz et al found that the use of clofarabine instead of an anthracycline and etoposide in the first course of induction therapy may be a feasible strategy in pediatric patients with acute myeloid leukemia. The trial,...
Association of Antibodies With Pegaspargase Allergic Reactions and Failure of Rechallenge in Pediatric ALL
In a study reported in the Journal of Clinical Oncology, Liu et al determined the frequency of allergic reactions and consequences of development of antibodies to pegaspargase (PEG-ASP) among pediatric patients with newly diagnosed acute lymphoblastic leukemia (ALL). As noted by the...
EHA 2019: ASCEND Trial Compares Acalabrutinib vs Investigator’s Choice in Relapsed or Refractory CLL
The randomized, global, multicenter, open-label phase III ASCEND trial evaluated the efficacy and safety of acalabrutinib vs investigator’s choice of rituximab/idelalisib or rituximab/bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Ghia et al presented ...
EHA 2019: CLL12 Trial Investigates Ibrutinib in Previously Untreated, Asymptomatic Early-Stage CLL
At the 24th Annual Congress of the European Hematology Association (EHA), Langerbeins et al presented findings from the phase III CLL12 trial, which evaluated whether ibrutinib prolongs event-free survival in patients with previously untreated, Binet stage A chronic lymphocytic leukemia (CLL)...
QuANTUM-R: Quizartinib vs Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD–Positive AML
In the phase III QuANTUM-R trial reported in The Lancet Oncology, Cortes et al found that the FLT3 inhibitor quizartinib produced a modest but significant improvement in overall survival vs salvage chemotherapy in relapsed or refractory FLT3 internal tandem duplication (FLT3-ITD)-positive acute...
2019 ASCO: CLL14 Trial Evaluates First-Line Venetoclax/Obinutuzumab in Previously Untreated CLL
The phase III CLL14 trial—reported by Fischer et al at the 2019 ASCO Annual Meeting (Abstract 7502) and in The New England Journal of Medicine—found that the BCL2 inhibitor venetoclax plus the monoclonal antibody obinutuzumab prolonged progression-free survival vs obinutuzumab and...
First-Line Ibrutinib and Venetoclax for High-Risk and Older Patients With Previously Untreated CLL
In a single-center phase II trial reported in The New England Journal of Medicine, Jain et al 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 patients...
Kerry A. Rogers, MD, on Chronic Lymphocytic Leukemia: Acalabrutinib With Obinutuzumab in Treatment-Naive and Relapsed or Refractory Disease
Kerry A. Rogers, MD, of The Ohio State University, discusses a 3-year follow-up of phase Ib safety and efficacy findings with the selective BTK inhibitor acalabrutinib and the anti-CD20 monoclonal antibody obinutuzumab in patients with CLL (Abstract 7500).
Mark J. Levis, MD, PhD, on Acute Myeloid Leukemia: Gilteritinib in FLT3-Mutated Disease
Mark J. Levis, MD, PhD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, discusses the effect of gilteritinib on survival in patients with FLT3-mutated relapsed/refractory AML who have common co-mutations or a high FLT3-ITD allelic ratio, and the importance of FLT3-ITD...
FDA Approves Addition of Survival Data to Gilteritinib Label for Refractory FLT3-Mutated AML
On May 29, the U.S. Food and Drug Administration (FDA) approved the addition of overall survival data in the labeling for gilteritinib (Xospata), which is indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation as detected by an FDA-approved...
FDA Pipeline: Designations in Myeloma, Adenoid Cystic Carcinoma, and Kaposi Sarcoma, Plus ODAC Votes
This week, the U.S. Food and Drug Administration granted designations in relapsed or refractory multiple myeloma, adenoid cystic carcinoma, and Kaposi sarcoma; and the FDA’s Oncologic Drugs Advisory Committee (ODAC) held votes on treatments for tenosynovial giant cell tumor and acute...
FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL
The U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The approval is based on the results of the...
FDA Pipeline: Applications and Designations in Prostate Cancer, Leukemia, and HER2-Positive Cancers
In the past 2 weeks, the U.S. Food and Drug Administration (FDA) accepted a new drug application and granted Priority Review for a prostate cancer treatment, granted Orphan Drug designation to a treatment for acute lymphoblastic leukemia, accepted an investigational new drug application for a...
FDA Approves First-Line Ivosidenib for IDH1-Mutated AML
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
Long-Term Follow-up: Addition of Idelalisib to Rituximab in Relapsed Chronic Lymphocytic Leukemia
In an article published in the Journal of Clinical Oncology, Sharman et al provided long-term findings of a phase III trial that examined the addition of idelalisib to rituximab in relapsed chronic lymphocytic leukemia (CLL), including findings from an extension phase of idelalisib monotherapy. The ...
Intermittent vs Intensive PEG-Asparaginase in Pediatric Acute Lymphoblastic Leukemia
In a Scandinavian study reported in the Journal of Clinical Oncology, Albertsen et al found that use of intermittent vs intensive pegylated (PEG)-asparaginase was associated with similar efficacy and reduced asparaginase-related toxicity in pediatric acute lymphoblastic leukemia (ALL). The study...
FDA Pipeline: Designations for Myelodysplastic Syndromes, Triple-Negative Breast Cancer, AML, and EBV-Associated Cancers
Over the past week, the U.S. Food and Drug Administration (FDA) granted several Fast Track and Orphan Drug designations to treatments for myelodysplastic syndromes, triple-negative breast cancer, acute myeloid leukemia (AML), and Epstein-Barr virus (EBV)-associated cancers. Fast Track Designation...
FDA Pipeline: Designations in Glioblastoma, Neurofibromatosis, Multiple Myeloma, and AML
This week, the U.S. Food and Drug Administration (FDA) granted designations for treatments for recurrent glioblastoma, neurofibromatosis type 1 and plexiform neurofibromas, multiple myeloma, and relapsed or refractory FLT3-ITD acute myeloid leukemia (AML). Fast Track Designation for Ad-RTS-hIL-12...
AACR 2019: Gilteritinib in Patients With FLT3-Mutated Acute Myeloid Leukemia
Treatment with the FLT3-targeted therapeutic gilteritinib improved survival for patients with relapsed or refractory acute myeloid leukemia (AML) harboring an FLT3 mutation compared with standard chemotherapy regimens, according to results from the phase III ADMIRAL trial presented by Perl et al at ...
FDA Pipeline: Mammography Policies, Designations for Leukemias and Myelodysplastic Syndrome
This week, the U.S. Food and Drug Administration (FDA) announced policy changes to modernize mammography policies and issued a Breakthrough Therapy designation, an Orphan Drug designation, and an investigational new drug application. FDA Advances Policy Changes to Modernize Mammography Services...
Venetoclax Plus Low-Dose Cytarabine in Older Patients With Previously Untreated AML Ineligible for Intensive Chemotherapy
In a phase Ib/II trial reported in the Journal of Clinical Oncology, Wei et al found that the combination of venetoclax and low-dose cytarabine produced a high response rate in previously untreated older patients with acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy. In...
FDA Pipeline: Assay Approval, Breakthrough Designations for AI Technology and CLL, and More
In the past week, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic assay, granted Breakthrough Device and Breakthrough Therapy designations, and extended the review period of a proposed treatment. The agency also published four draft guidances and one final guidance...
Effect of Hematopoietic Stem Cell Transplantation on Outcome in Pediatric Hypodiploid B-ALL
In a report from the Children’s Oncology Group (COG) in the Journal of Clinical Oncology, McNeer et al found that hematopoietic stem cell transplantation (HSCT) did not improve outcomes in pediatric patients with hypodiploid B-lymphoblastic leukemia (B-ALL). Study Details The study was a...
FDA Pipeline: Updates on Treatments for Cervical Cancer, Myelofibrosis, Chemotherapy-Induced Nausea and Vomiting, and More
The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...
Stefan O. Ciurea, MD, on Infusing High Doses of Natural Killer Cells: An Enhanced Antitumor Effect
Stefan O. Ciurea, MD, of The University of Texas MD Anderson Cancer Center, discusses the enhanced antitumor effect and lower viral reactivation that result from high doses of natural killer cells infused after haploidentical transplantation, with no excess graft-vs-host disease, a low relapse rate ...
FDA Pipeline: Priority Reviews in Solid Tumors and Lymphoma; Plus an sNDA in Acute Myeloid Leukemia
Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews and accepted a supplemental new drug application: Priority Review for Entrectinib in NTRK Fusion–Positive Solid Tumors and Metastatic, ROS1-Positive NSCLC This week, the FDA accepted new drug...
ERG Gene Variations and Risk of ALL in Hispanic Children
Scientists have identified genetic variations in a fourth gene that are associated with an increased risk of acute lymphoblastic leukemia (ALL) in Hispanic children. These findings were published by Qian et al in Blood. The gene is ERG, a transcription factor that is also...
Treatment Outcomes for Children With Hypodiploid Acute Lymphoblastic Leukemia
In a retrospective study reported in the Journal of Clinical Oncology, Pui et al found that minimal residual disease (MRD)-negative status, high hypodiploidy with 44 chromosomes, and MRD-stratified treatment were associated with improved outcomes among children treated for newly diagnosed...
FDA Approves Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL
Today, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica), a Bruton's tyrosine kinase inhibitor, in combination with obinutuzumab in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first approval of a...
