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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 ...
The Bruton’s tyrosine kinase (BTK) inhibitors have been one of the most exciting advances in the tre atment of 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 studies where...
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 the investigator’s choice of...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for a novel dosing regimen for durvalumab as well as for trilaciclib in small cell lung cancer; granted Fast Track designations to treatments for glioblastoma and B-cell acute lymphoblastic leukemia; and issued reports...
In a Chinese phase III trial reported in The Lancet Oncology, Xuan et al found that sorafenib maintenance after allogeneic hematopoietic stem cell transplantation significantly reduced the risk of relapse vs no maintenance therapy in patients with FLT3–internal tandem duplication (ITD)–positive...
In the phase III VIALE-A trial reported in The New England Journal of Medicine, Courtney D. DiNardo, MD, and colleagues found that venetoclax plus azacitidine significantly improved overall survival vs azacitidine alone in previously untreated patients with acute myeloid leukemia (AML) who were...
Recently, the U.S. Food and Drug Administration (FDA) approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with non–small cell lung cancer (NSCLC) and specific types of EGFR mutations. The FDA also granted Fast Track...
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...
On June 16, 2020, the indication of gemtuzumab ozogamicin (Mylotarg) for newly diagnosed CD33-positive acute myeloid leukemia (AML) was extended to include pediatric patients aged 1 month and older.1,2 Supporting Efficacy Data Approval was supported by findings from the phase III AAML0531 trial...
Findings from a study published by Eisfeld et al in the journal Leukemia could refine an important set of prognostic and treatment recommendations for younger adult patients with acute myeloid leukemia (AML). The retrospective study evaluated the molecular characteristics and outcomes of 863...
In an analysis from the Childhood Cancer Survivor Study reported in the Journal of Clinical Oncology, Dixon et al found that 5-year survivors of childhood acute lymphoblastic leukemia (ALL) diagnosed and treated with risk-stratified therapy in the 1990s had reduced morbidity and health-related late ...
In the German-Austrian phase II SORMAIN trial reported in the Journal of Clinical Oncology, Burchert et al found that maintenance treatment with sorafenib vs placebo was associated with significantly prolonged relapse-free survival after allogeneic hematopoietic stem cell transplantation (HCT) in...
Alfonso Bencomo Álvarez, PhD, of Texas Tech University Health Sciences Center, discusses his retrospective study of the incidence and survival for patients with hematologic malignancies residing at the United States/Mexico border. The analysis showed that 10-year survival rates for Hispanic patients with ALL, AML, and CML were significantly lower for those who lived in El Paso than for those who lived elsewhere in Texas (Abstract 4343).
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 tolerate intensive chemotherapy (Abstract S136).
Alice Mims, MD, Associate Professor of Hematology at The Ohio State University Comprehensive Cancer Center–The James, shared her insights on the VIALE-A study. “The results of the VIALE-A study have been highly anticipated and are exciting, given the improvement seen in both overall survival and...
In the phase III VIALE-A trial, venetoclax added to azacitidine led to a significant and clinically meaningful improvement in response rates and overall survival, as compared with azacitidine alone, in treatment-naive predominantly elderly patients with acute myeloid leukemia (AML) ineligible for...
In a single-institution study reported in JCO Oncology Practice, Watson et al found that screening for and treating detected dental infections prior to initiation of induction chemotherapy for patients with newly diagnosed acute myeloid leukemia (AML) were associated with a significant reduction in ...