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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).
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).
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).
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).
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....
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,...
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)....
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....
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...
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...
FDA Accepts New Drug Application, Grants Priority Review for Duvelisib in CLL/SLL and Follicular Lymphoma
On April 9, the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review a new drug application (NDA) for the oral agent duvelisib, a first-in-class, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. The NDA is seeking full approval for duvelisib in...
Targeted Sequencing Detection of Molecular Minimal Residual Disease and Prognosis in AML
In a study reported in The New England Journal of Medicine, Jongen-Lavrencic et al found that molecular minimal residual disease identified by next-generation sequencing during complete remission was associated with increased risk of relapse and mortality over 4 years of follow-up in patients with...
FDA Accepts BLA for Moxetumomab Pasudotox in Hairy Cell Leukemia
On April 3, the U.S. Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at ...
Venetoclax Plus Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia
In the phase III MURANO trial reported in The New England Journal of Medicine by Seymour et al, the combination of the BCL2 inhibitor venetoclax (Venclexta) with rituximab (Rituxan) markedly improved progression-free survival vs bendamustine plus rituximab in patients with relapsed or refractory...
FDA Expands Approval of Blinatumomab for Certain Patients With B-Cell Precursor ALL
The U.S. Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). In patients who have achieved remission after...
IKZF1 Deletion–Based Gene Profile and Outcome in Pediatric B-Cell Precursor ALL
In a study reported in the Journal of Clinical Oncology, Stanulla et al found that a gene profile including somatic deletions in the lymphoid transcription factor–coding gene IKZF1 and deletions in other genes was associated with minimal residual disease (MRD)-dependent very-poor prognosis...
Bijal D. Shah, MD, on What ALL Tells Us About CAR T Cells
Bijal D. Shah, MD, of the H. Lee Moffitt Cancer Center, discusses key studies of CAR T-cell therapy in relapsed B-cell ALL and the adverse events that this treatment may cause.
FDA Expands Nilotinib Indication to Pediatric Patients With CML
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for nilotinib (Tasigna) to include treatment of first- and second-line pediatric patients 1 year of age or older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase. In the United...
Ellin Berman, MD, on CML: Disease Management During Pregnancy
Ellin Berman, MD, of Memorial Sloan Kettering Cancer Center, discusses the effects of TKI therapy on fetal development, its impact on pregnancy outcomes, and how to develop an effective treatment plan.
Prognostic Factors for Complete Response to Ibrutinib in Chronic Lymphocytic Leukemia
In an analysis of two pooled studies reported in JAMA Oncology, O’Brien et al found that a complete response to ibrutinib (Imbruvica) in the treatment of chronic lymphocytic leukemia was more likely in patients receiving the agent as first-line therapy and in those without bulky disease....
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...
Dasatinib for Pediatric Chronic Myeloid Leukemia in Chronic Phase
As reported in the Journal of Clinical Oncology by Gore et al, a phase II trial has shown high response rates with dasatinib treatment in pediatric patients with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP). Findings in the trial supported the...
FDA Accepts BLA for Calaspargase Pegol in Acute Lymphoblastic Leukemia
On February 28, Shire announced that the U.S. Food and Drug Administration (FDA) accepted the company’s biologics license application (BLA) for calaspargase pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component of a multiagent chemotherapeutic regimen...
FDA Accepts NDA, Grants Priority Review for Ivosidenib in Relapsed or Refractory IDH1-Mutated AML
On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review...
FDA’s Oncologic Drugs Advisory Committee to Review Potential New Use of Blinatumomab
On February 14, Amgen announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the supplemental biologics license application (sBLA) for blinatumomab (Blincyto) for the treatment of patients with minimal residual disease...
Updated Analysis of ELIANA Trial Shows Longer-Term Durable Remissions With Tisagenlecleucel in Children, Young Adults With Relapsed/Refractory ALL
Updated results from the ELIANA clinical trial of tisagenlecleucel (Kymriah), formerly CTL019, in relapsed or refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) have been published by Maude et al in The New England Journal of Medicine. New data include...
Addition of Antibody-Drug Conjugate to Low-Intensity Chemotherapy in Older Patients With ALL
In a single-center phase II study reported in The Lancet Oncology, Kantarjian et al found that the addition of inotuzumab ozogamicin (Besponsa) to low-intensity chemotherapy produced promising outcomes in older patients with newly diagnosed Philadelphia chromosome–negative acute lymphoblastic ...
Kristen Fousek, PhD Candidate, on B-Cell ALL: CAR T-Cell Treatment
Kristen Fousek, PhD Candidate at Baylor College of Medicine, discusses her preclinical work on targeting CD19-negative relapsed B-cell acute lymphoblastic leukemia, using CAR T cells that target three antigens simultaneously, a technique that addresses the growing problem of relapse (Abstract 121).
Effect of TP53 Germline Variations on Outcomes in Pediatric B-Cell ALL
In a study reported in the Journal of Clinical Oncology, Qian et al found that loss-of-function germline TP53 variants increase the risk of childhood B-cell acute lymphoblastic leukemia (ALL), as well as the risk of poorer response to therapy and second malignancies. Study Details In the study,...
Arsenic Trioxide With Tretinoin for First-Line Treatment of Acute Promyelocytic Leukemia Approved by the FDA
On January 15, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17)...
Radioiodine Treatment of Well-Differentiated Thyroid Cancer and Hematologic Malignancy Risk
In a study reported in the Journal of Clinical Oncology, Molenaar et al found that radioiodine treatment for well-differentiated thyroid cancer was associated with an increased risk of acute myeloid leukemia (AML) and chronic myeloid leukemia (CML) compared with thyroidectomy alone. Study Details ...
Venetoclax in Chronic Lymphocytic Leukemia Progressing After Ibrutinib
An interim analysis of a phase II trial reported by Jones et al in The Lancet Oncology indicates that venetoclax (Venclexta) produces a response in a high proportion of patients with chronic lymphocytic leukemia progressing on or after ibrutinib (Imbruvica) treatment. Study Details The study...
FDA Updates Nilotinib Label With Information on Discontinuing Treatment in Certain Patients With Early-Phase CML After Sustained Response
On December 22, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with...
ICER Releases Draft Evidence Report on CAR T-Cell Therapy for B-Cell Cancers
On December 19, the Institute for Clinical and Economic Review (ICER) released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta). The draft report, along with draft voting...
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). BFORE Trial Approval was based on data from ...
ASH 2017: Dasatinib Plus Standard Chemotherapy Demonstrates 3-Year Survival Benefit in Pediatric Patients With Philadelphia Chromosome–Positive ALL
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Hunger et al presented data from the phase II CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) treated with dasatinib (Sprycel) added ...
ASH 2017: MURANO Trial: Venetoclax Found Superior to Standard Chemotherapy When Combined With Rituximab in CLL
In the phase III MURANO trial, treatment with the targeted cancer drug venetoclax (Venclexta) in combination with rituximab (Rituxan) more than doubled the likelihood that patients with chronic lymphocytic leukemia (CLL) would survive for 2 years without cancer progression, compared to treatment...
ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials
In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...
John F. Seymour, MBBS, PhD, on CLL: Results From the MURANO Study
John F. Seymour, MBBS, PhD, of the Peter MacCallum Cancer Centre, discusses an interim analysis of venetoclax plus rituximab vs bendamustine plus rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (Abstract LBA-2).
Nitin Jain, MD, on CLL: Results From a Venetoclax/Ibrutinib Trial
Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses phase II study results on combined venetoclax and ibrutinib for patients with previously untreated high-risk and relapsed/refractory chronic lymphocytic leukemia (Abstract 429).
ASH 2017: CLARITY Trial: Combination Treatment With Two Targeted Agents Shows Promise in Previously Treated CLL
One-third of patients with previously treated chronic lymphocytic leukemia (CLL) had no detectable disease after 6 months of combination therapy with the targeted agents ibrutinib (Imbruvica) and venetoclax (Venclexta), with no increase in the occurrence of tumor-lysis syndrome, a serious treatment ...
ASH 2017: RESONATE-2 Trial: Patient-Reported Outcomes on Ibrutinib Treatment in Patients With CLL
At the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition, the 3-year follow-up data from the RESONATE-2 study (PCYC-1115/1116) were presented. The investigators found that patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)...
Watch for More From ASH 2017
Phase III ASPIRE Trial of Carfilzomib in Relapsed Multiple Myeloma Overall survival results from the phase III ASPIRE trial will be detailed for the first time in an oral presentation by Stewart et al on Monday, December 11. The addition of carfilzomib to lenalidomide and...
Patients With CLL May Be Willing to Trade Treatment Efficacy for Reduced Side Effects
When choosing their preferred treatment, patients with chronic lymphocytic leukemia (CLL) place the highest value on treatments that deliver the longest progression-free survival, but they are willing to swap some drug efficacy for a reduced risk of serious adverse events, according to a study...
Constructing a Risk Stratification Model for Pediatric Acute Lymphoblastic Leukemia
In a study reported in the Journal of Clinical Oncology, O’Connor et al combined genetic subtypes and minimal residual disease as a continuous variable to construct a risk stratification model for pediatric acute lymphoblastic leukemia (ALL). Study Details The study involved a...
Seattle Children’s Opens Trial for Children and Young Adults With Leukemia That Targets CD22 and CD19 Proteins Simultaneously
Seattle Children’s has opened the first chimeric antigen receptor (CAR) T-cell immunotherapy trial in the U.S. for children and young adults with relapsed or refractory CD19- and CD22-positive acute lymphoblastic leukemia (ALL) that will simultaneously attack two targets on cancer cells. With ...
Comparison of First-Line Treatments in Chronic Myeloid Leukemia
In the phase III BFORE trial reported in the Journal of Clinical Oncology by Cortes et al, the SRC/ABL kinase inhibitor bosutinib (Bosulif) improved response rates vs imatinib in first-line treatment of patients with Philadelphia chromosome (Ph)-positive chronic phase chronic myeloid leukemia (CML) ...
FDA Grants Regular Approval of Dasatinib for Pediatric Philadelphia Chromosome–Positive CML in Chronic Phase
On November 9, the U.S. Food and Drug Administration (FDA) expanded the indication for dasatinib (Sprycel) tablets to include the treatment of children with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase (CP).This approval for dasatinib in pediatric patients...
Fat Cells May Inactivate Chemotherapeutic Drug and Contribute to Poorer Survival in ALL
It is well established that obesity increases the risk for cancer mortality, although no mechanisms have been proven to explain the reason for this association. Now a laboratory study investigating how obesity might alter the effectiveness of daunorubicin in the treatment of acute lymphoblastic...
MicroRNA Expression–Based Risk Model for Pediatric Acute Myeloid Leukemia
As reported in the Journal of Clinical Oncology, Lim et al have identified a microRNA expression–based risk model associated with event-free survival in pediatric acute myeloid leukemia (AML). The study involved comprehensive miRNA sequencing of 1,362 pediatric AML samples, consisting of...
