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In a phase I trial reported in The New England Journal of Medicine, Hughes et al found that asciminib, an oral BCR-ABL1 inhibitor with a mechanism of action different from available ABL1 tyrosine kinase inhibitors, was active in patients with chronic myeloid leukemia (CML) after failure of ABL...
As reported by Noelle V. Frey, MD, and colleagues in the Journal of Clinical Oncology, single-center experience with the anti-CD19 chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel has shown that high-dose fractionated infusion with the ability to modify dosing in case of early signs...
Late in 2018, the FLT3 inhibitor gilteritinib was approved for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA also approved an expanded indication...
To complement The ASCO Post’s comprehensive coverage of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic regimens for acute myeloid leukemia (AML). For full details of these...
On November 21, 2019, the Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib was approved for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 The review resulting in approval was conducted under Project Orbis, an initiative of the U.S....
In a study reported in the Journal of Clinical Oncology, Rank et al found a similar risk of asparaginase-associated pancreatitis in older children, adolescents, and adults and greater associated morbidity in adolescents with acute lymphoblastic leukemia treated according to the Nordic Society of...
Jeff P. Sharman, MD, of the Willamette Valley Cancer Institute and US Oncology Research, discusses phase III findings from the ELEVATE TN study, which showed that acalabrutinib plus obinutuzumab and acalabrutinib monotherapy improved progression-free survival in patients with treatment-naive chronic lymphocytic leukemia (Abstract 31).
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 intermediate-risk first relapse of B-cell acute lymphoblastic leukemia (Abstract LBA-1).
Ilaria Iacobucci, PhD, of St. Jude Children’s Research Hospital, discusses her work to more accurately define mutation subtypes in acute myeloid leukemia and myelodysplastic syndromes, as well as the implications for diagnosis, prognosis, and treatment (Abstract LBA-4 ).
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 could potentially turn a poor responder into a good responder who might even achieve treatment-free remission (Abstract 665).
Andrew H. Wei, MBBS, PhD, of The Alfred Hospital, Melbourne, discusses phase III findings on oral azacitidine (CC-486), the first treatment used in the maintenance setting shown to improve both overall and disease-free survival in patients with acute myeloid leukemia that is in remission following induction chemotherapy (Abstract LBA-3).
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).
Blinatumomab improved survival in children with relapsed B-acute lymphoblastic leukemia (B-ALL) compared with standard chemotherapy, accordings to findings from a study presented by Brown et al at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract LBA-1)....
Researchers have completed the first comprehensive analysis combining full genomic sequencing and gene-expression profiles of more than 1,300 patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The research was presented by Iacobucci et al during the 2019 American Society...
Treatment with an investigational oral form of azacitidine, CC-486, improved overall survival in older patients with newly diagnosed acute myeloid leukemia (AML) who were in remission following standard induction chemotherapy with or without consolidation therapy, according to a phase III study...
A study of more than 1,000 patients with acute myeloid leukemia (AML) revealed that African Americans were more likely to have evidence of abnormal kidney functioning than whites, but this was not associated with any difference in overall survival. The findings, presented by Statler et al at the...
For older patients with acute myeloid leukemia (AML), the prospects for success of a stem cell transplant can often be predicted based on the particular set of leukemic genetic characteristics, according to results presented by Murdock et al at the 2019 American Society of Hematology (ASH) Annual...
Tait D. Shanafelt, MD, of Stanford University, discusses extended follow-up data that show ibrutinib plus rituximab improved clinical outcomes vs the standard therapy of fludarabine/cyclophosphamide/ rituximab in younger patients with previously untreated chronic lymphocytic leukemia (Abstract 33).
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).
Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses findings from two studies showing that the combination of ibrutinib and venetoclax is an effective chemotherapy-free oral regimen for patients with high-risk, previously untreated chronic lymphocytic leukemia (Abstract 34).
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 intensive chemotherapy (Abstract 177).
Children from lower-income neighborhoods were 2.4 times more likely to die during treatment for acute myeloid leukemia (AML) than children from middle- and high-income neighborhoods, according to findings from a study that analyzed nearly 1,500 clinical trial participants. While previous research...
In late 2018, calaspargase pegol-mknl, an asparagine-specific enzyme, was approved for use as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to 21 years.1,2 The new product provides for a longer interval ...
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. Late in 2018, the Hedgehog pathway inhibitor glasdegib...
On November 21, as part of Project Orbis—a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada—the U.S. Food and Drug Administration (FDA) granted supplemental approval to acalabrutinib (Calquence) for the treatment of adults with chronic lymphocytic leukemia...
In an analysis of the German ALL-REZ BFM 2002 trial, reported in the Journal of Clinical Oncology, Eckert et al found that postinduction minimal residual disease (MRD)-based treatment stratification resulted in “excellent survival” in pediatric patients with late relapse of B-cell precursor acute...
Although stem cells throughout the body acquire genetic mutations over time, usually these alterations do not affect how the stem cells function or cause disease. However, recent research in clonal hematopoiesis and aging has found an association between clonal expansion of hematopoietic cells with ...
On May 15, 2019, venetoclax was approved for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 Supporting Efficacy Data Approval was based on findings from the open-label phase III CLL14 trial (ClinicalTrials.gov...
As reported in The New England Journal of Medicine by Perl et al, the phase III ADMIRAL trial showed improved overall survival with the oral FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib vs salvage chemotherapy in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia...
In a phase I trial, the combination of the BCR-ABL1 inhibitor asciminib and the small-molecule kinase inhibitor imatinib showed preliminary efficacy, safety, and tolerability in patients with chronic myeloid leukemia (CML) resistant to or intolerant of treatment with two or more prior tyrosine...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to trastuzumab deruxtecan for the treatment of HER2-positive metastatic breast cancer; granted Fast Track designation for bemcentinib for elderly patients with relapsed acute myeloid leukemia (AML); granted Breakthrough...
In a retrospective cohort study reported in The Lancet Oncology, Herling et al identified a 17-gene signature that distinguished patients with IGHV-unmutated chronic lymphocytic leukemia (CLL) more likely to achieve long-term remission after front-line chemoimmunotherapy with fludarabine,...
The advent of new targeted agents for chronic lymphocytic leukemia (CLL) has ushered in a golden age of treatment, leading to longer, more durable periods of disease control. Not all oncologists are convinced, however, that improvements in progression-free survival alone warrant dispensing with...
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, 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 chemoimmunotherapy as a fixed duration treatment.
In the past few weeks, the U.S. Food and Drug Administration (FDA) has issued regulatory decisions in prostate cancer, urothelial cancer, myelofibrosis, breast cancer, pediatric brain cancer, leukemia, and skin cancer. Breakthrough Therapy Designation for Niraparib in Metastatic...
In a phase I trial, the combination of the BCR-ABL1 inhibitor asciminib and the small-molecule kinase inhibitor imatinib showed preliminary efficacy, safety, and tolerability in patients with chronic myeloid leukemia (CML) resistant to or intolerant of treatment with two or more prior tyrosine...
In 1994, I was a normal, active 15-year-old, who loved cars, sports, and rock music, especially songs from my favorite group, The Clash. In fact, it was while jubilantly dancing alone in my room to one of their tunes that I vomited into my hands, an early symptom of acute myeloid leukemia (AML). I...
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to magrolimab in myelodysplastic syndrome and acute myeloid leukemia (AML). The agency also granted Breakthrough Therapy designations in lung cancer and desmoid tumors, as well as Breakthrough Device designations...
In a study reported in the Journal of Clinical Oncology, Pelland-Marcotte et al found that survivors of childhood leukemia remained at significantly increased risk of infection compared with matched controls during an extended period following completion of treatment. Study Details The...
In a study reported in the Journal of Clinical Oncology, Angenendt et al found that adverse-risk cytogenetics were associated with significantly poorer outcomes vs normal karyotype among patients with acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation. As stated by the...
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...
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...
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...
In a single-center phase II trial reported in The New England Journal of Medicine, Nitin Jain, MD, and colleagues 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 ...
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....
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...
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....
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,...
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 ...