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Matthew S. Davids, MD, of Dana-Farber Cancer Institute, summarizes three key studies from a session he co-moderated on ibrutinib plus venetoclax for first-line treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), long-term responses to these agents for relapsed and refractory CLL, and undetectable minimal residual disease following fixed-duration treatment with venetoclax and rituximab for CLL (Abstracts 123, 124, and 125).
David T. Teachey, MD, of the University of Pennsylvania and Children’s Hospital of Philadelphia, discusses data showing that cranial radiation might be eliminated in most children with T-cell acute lymphoblastic leukemia and that bortezomib may improve survival in children with T-cell lymphoblastic lymphoma (Abstract 266).
Results from a phase II study presented by Nicholas J. Short, MD, and colleagues at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 464) showed that first-line treatment with a regimen of chemotherapy combined with the monoclonal antibody blinatumomab...
David Snyder, MD, Acting Chair, City of Hope Department of Hematology & Hematopoietic Cell Transplantation, Duarte, California, who was not involved in the ASCEMBL study, commented on the promise of asciminib: “The hope is this drug would be able to overcome resistance to other tyrosine kinase...
Since the introduction of imatinib almost 18 years ago, similar next-generation tyrosine kinase inhibitors have been approved for chronic myeloid leukemia (CML), including dasatinib, nilotinib, bosutinib, and ponatinib. These drugs attack a similar target, making it more likely that resistance to...
The BCL2 inhibitor venetoclax can be safely added to standard therapies for some high-risk myeloid blood cancers, and in early studies, the combination showed improved outcomes, according to two reports presented by Jacqueline S. Garcia, MD, and colleagues at the 2020 American Society of Hematology ...
Curtis Lachowiez, MD, of The University of Texas MD Anderson Cancer Center, discusses an interim analysis of a phase Ib/II study showing that venetoclax plus chemotherapy represents an effective regimen, particularly in patients with newly diagnosed and relapsed or refractory acute myeloid leukemia. The regimen appears to be an effective bridge to hematopoietic stem cell transplantation (Abstract 332).
A phase I/II study found that IMGN632, a novel CD123-targeting antibody-drug conjugate, was tolerable and resulted in a 29% overall response rate in patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare but aggressive form of leukemia. Treatment with the...
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 molecular risk profiles (Abstract 6).
It has been well documented that, collectively, Black individuals have the highest death rate and shortest survival of any racial/ethnic group in the United States for most cancers. Black men also have the highest cancer incidence. Although the causes of these inequities are complex, a study by...
Studies show that non-Hispanic Black and Hispanic patients with acute myeloid leukemia (AML) have higher mortality rates than non-Hispanic White patients diagnosed with the disease, despite lower rates of incidence, more favorable genetics, and a younger age at disease onset. A study by Abraham et...
Recently, the U.S. Food and Drug Administration (FDA) has issued regulatory decisions for agents to treat diffuse large B-cell lymphoma (DLBCL), small cell lung cancer (SCLC), acute myeloid leukemia (AML), biliary tract cancer, and graft-vs-host disease. Priority Review for Loncastuximab Tesirine...
In an Italian phase II trial (GIMEMA LAL2116) reported in The New England Journal of Medicine, Robin Foà, MD, of Sapienza University of Rome, and colleagues, found that first-line induction and consolidation treatment with dasatinib and blinatumomab produced a high rates of molecular response as...
On October 16, 2020, venetoclax was granted regular approval for use in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or those with comorbidities precluding intensive induction...
As reported in the Journal of Clinical Oncology by Arnon P. Kater, MD, PhD, of Amsterdam University Medical Centers, and colleagues,1 the 4-year progression-free and overall survival rates were significantly higher with venetoclax plus rituximab vs bendamustine plus rituximab in the phase III...
The Bruton’s tyrosine kinase (BTK) inhibitors have been one of the most exciting advances in the treatment of patients with chronic lymphocytic leukemia (CLL) and have led to the development of chemotherapy-free treatments for both treatment-naive as well as relapsed or refractory CLL based on...
As reported in the Journal of Clinical Oncology by Paolo Ghia, MD, PhD, of the Università Vita-Salute San Raffaele, Milan, Italy, and colleagues, the phase III ASCEND trial showed significantly prolonged progression-free survival with acalabrutinib monotherapy vs investigator’s choice of either...
Daratumumab and hyaluronidase-fihj: On May 1, 2020, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex) for adult patients with newly diagnosed or relapsed or refractory multiple myeloma. Ibrutinib: On April 21, 2020, the FDA expanded the indication of ibrutinib (Imbruvica) to include...
Venetoclax: On October 16, 2020, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older. See page 32 for more on this approval....
The past year has seen remarkable advances in the treatment of leukemia, lymphoma, and multiple myeloma, which combined account for 9.9% of the estimated 1,806,590 new cases of cancer diagnosed in the United States and an estimated 56,840 cancer-related deaths.1 Novel therapies are providing...
On October 16, 2020, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older or who have comorbidities precluding...
The American Society of Hematology (ASH) has published new guidelines to help older adults with acute myeloid leukemia (AML) and their health-care providers make critical care decisions, including if and how to proceed with cancer treatment and the need for blood transfusions for those in hospice...
In the treatment of adults with acute lymphoblastic leukemia (ALL), use of newer antibodies and de-intensification of chemotherapy have greatly improved outcomes, according to Hagop Kantarjian, MD, FASCO, who has been very involved in much of the research in ALL treatment. Dr. Kantarjian, Professor ...
In a study (Life After Stopping TKIs; LAST) reported in JAMA Oncology, Atallah et al found that stopping tyrosine kinase inhibitor (TKI) therapy in patients with controlled chronic myeloid leukemia (CML) was associated with maintenance of major molecular response and achievement of treatment-free...
As reported in The Lancet Oncology by Shaji K. Kumar, MD, and colleagues, the phase III BELLINI trial has shown that the addition of venetoclax to bortezomib/dexamethasone significantly prolonged progression-free survival in patients with relapsed or refractory multiple myeloma but was associated...
In a phase Ib study reported in the Journal of Clinical Oncology, Courtney D. DiNardo, MD, and colleagues found that the combination of ivosidenib and azacitidine produced a high response rate in patients with newly diagnosed isocitrate dehydrogenase 1 (IDH1)-mutant acute myeloid leukemia...
In a study reported in JCO Oncology Practice, Anand P. Jillella, MD, and colleagues found that physician education on the main causes of death during induction treatment for acute promyelocytic leukemia (APL)—and comanagement of cases with expert physicians—resulted in a low early mortality rate...
In a Chinese phase II trial reported in the Journal of Clinical Oncology, Gao et al found that prophylactic recombinant human granulocyte colony-stimulating factor (rhG-CSF) and minimal-dose decitabine reduced the risk of relapse vs no intervention among patients with high-risk, minimal residual...
At the National Comprehensive Cancer Network® (NCCN®) 2020 Virtual Congress: Hematologic Malignancies, William Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, reviewed current data on chronic lymphocytic leukemia (CLL), including promising new combinations of modern...
In a single-institution phase I dose-escalation and -expansion trial reported as a letter in Nature Medicine, Shah et al found that treatment with tandem bispecific anti-CD20/anti-CD19 4-1BB–CD3ζ lentiviral (LV20.19) chimeric antigen receptor (CAR) T cells produced high response rates in adult...
In a single-institution study reported in the Journal of Clinical Oncology, Palmieri et al found that the Ferrara criteria for determining fitness for intensive chemotherapy—a set of consensus criteria proposed by a panel of experts from the Italian Society of Hematology, Italian Society of...
In a first-in-human phase I trial reported in the Journal of Clinical Oncology, Salamero et al identified toxicities and activity associated with iadademstat, an oral first-in-class lysine-specific histone demethylase 1A (LSD1) inhibitor, in patients with relapsed or refractory acute myeloid...
In an Italian phase II trial (GIMEMA LAL2116) reported in The New England Journal of Medicine, Foà et al found that first-line induction and consolidation treatment with dasatinib plus blinatumomab produced a high rate of molecular response in adults with Philadelphia chromosome–positive acute...
Two small phase I studies at separate centers demonstrated encouraging results in the treatment of children with acute lymphoblastic leukemia (ALL) using reinfused autologous genetically engineered T cells. Results of both studies were presented at the Annual Meeting of the American Association for ...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for EGFR-mutant lung cancer and advanced renal cell carcinoma; granted Fast Track designation to agents in chronic lymphocytic leukemia (CLL) and locally advanced or metastatic solid tumors; and more....
In a systematic review and meta-analysis reported in JAMA Oncology, Nicholas J. Short, MD, and colleagues found that minimal (or measurable) residual disease (MRD) negativity is associated with superior disease-free and overall survival in patients with acute myeloid leukemia (AML). As stated by...
On October 16, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults age 75 or older or who have comorbidities precluding intensive ...
As reported in the Journal of Clinical Oncology, Ahn et al developed a four-factor model that identified risk groups for poorer outcomes among patients treated with ibrutinib for chronic lymphocytic leukemia. Study Details Patients treated with ibrutinib in phase II and III trials constituted the...
As reported in the Journal of Clinical Oncology by Kimberly P. Dunsmore, MD, of the Virginia Tech Carilion School of Medicine and Carilion Clinic, Roanoke, and colleagues, the phase III Children’s Oncology Group AALL0434 trial has shown that the addition of nelarabine to standard therapy improved...
As reported in the Journal of Clinical Oncology by Kater et al, 4-year progression-free and overall survival were significantly greater with venetoclax plus rituximab vs bendamustine plus rituximab in the phase III MURANO trial in patients with relapsed or refractory chronic lymphocytic leukemia....
In the phase III VIALE-A trial reported in The New England Journal of Medicine, Courtney D. DiNardo, MD, MSCE, of The University of Texas MD Anderson Cancer Center, and colleagues found that venetoclax plus azacitidine significantly improved overall survival vs azacitidine alone in previously...
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 September 1, 2020, azacitidine tabletswere approved...
Recently, the U.S. Food and Drug Administration (FDA) granted designations to agents for metastatic castration-resistant prostate cancer, recurrent glioblastoma, and pediatric acute myeloid leukemia. Fast Track Designation for EPI-7386 in Metastatic Castration-Resistant Prostate Cancer The FDA...
In the treatment of adults with acute lymphoblastic leukemia (ALL), use of newer antibodies and de-intensification of chemotherapy have greatly improved outcomes, according to Hagop Kantarjian, MD, who has been very involved in much of the research in ALL treatment. Dr. Kantarjian, Professor and...
Research published by Zhang et al in the Journal of the National Cancer Institute showed that an inherited variation in the GATA3 gene strongly influences early response to chemotherapy and is linked to relapse in children with acute lymphoblastic leukemia (ALL). Minimal residual disease (MRD)...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents for the treatment of refractory multiple myeloma, metastatic breast cancer, and metastatic non–small cell lung cancer (NSCLC); gave Fast Track designation to treatments for NTRK mutation–positive solid tumors...
As reported in The Lancet Oncology by Al-Sawaf et al, 3-year follow-up of the phase III CLL14 trial showed maintained significant improvement in progression-free survival with the fixed-duration regimen of venetoclax/obinutuzumab vs chlorambucil/obinutuzumab in previously untreated patients with...
On September 1, the U.S. Food and Drug Administration (FDA) approved oral azacitidine (Onureg; also known as CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or complete remission with incomplete blood count recovery...
As reported in the Journal of Clinical Oncology by Dunsmore et al, the phase III Children’s Oncology Group AALL0434 trial has shown that the addition of nelarabine to standard therapy improved disease-free survival in children and young adults with newly diagnosed T-cell acute lymphoblastic...
In a single-institution phase II trial reported in the Journal of Clinical Oncology, Rogers et al found that the combination of obinutuzumab, ibrutinib, and venetoclax produced high response rates in both treatment-naive and relapsed or refractory chronic lymphocytic leukemia. Study Details A total ...