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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 ...
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...
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...
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)...
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...
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...
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,...
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...
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 ...
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).
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).
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, 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, of the National Cancer Institute, discusses findings on moxetumomab pasudotox in heavily pretreated patients with relapsed or refractory hairy cell leukemia (Abstract 7004).
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....
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...
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...
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...
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,...
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)....
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...
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....
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...
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...
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...
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...
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...
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...
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 ...
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 (CLL) progressing on or after ibrutinib (Imbruvica) treatment. John C. Byrd, MD, of...
On March 22, 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 (CML) in the chronic phase. In the United ...
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...
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...
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, 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.
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 (CLL) progressing on or after ibrutinib (Imbruvica) treatment. John C. Byrd, MD, of The ...
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, 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.
The Samuel Waxman Cancer Research Foundation (SWCRF) announced that Martin S. Tallman, MD, Chief of Leukemia Service at Memorial Sloan Kettering Cancer Center (MSK), has joined its Scientific Advisory Board. Dr. Tallman, who will continue in his role at MSK, will join his fellow Scientific...
A novel approach to chimeric antigen receptor (CAR) T-cell therapy seems to effectively target acute lymphoblastic leukemia (ALL) cells with varying antigen profiles and may help to overcome antigen escape, seen with CD19-targeted therapy. According to data presented at the 2018 ASCO-SITC Clinical...
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....
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...
GUEST EDITOR Dr. Abraham is the Director of the Breast Oncology Program at Taussig Cancer Institute, and Professor of Medicine, Lerner College of Medicine, Cleveland Clinic. MATT KALAYCIO, MD Affiliation: Cleveland Clinic Taussig Cancer InstituteOn balancing priorities: “As an oncologist in...
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...
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...
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. On December 19, 2017, bosutinib (Bosulif) was granted...
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...
The use of maintenance therapy in older patients with acute myeloid leukemia (AML) is theoretically sensible, but its clinical value remains uncertain. The phase III HOVON97 randomized study demonstrated that maintenance therapy with the hypomethylating agent azacitidine may improve disease-free...
The results of a phase II trial have shown high activity of guadecitabine, a next-generation hypomethylating drug, in treatment-naive older patients with acute myeloid leukemia. The findings were reported in The Lancet Oncology by Hagop M. Kantarjian, MD, of The University of Texas MD Anderson...
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...