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 ...
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)...
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...
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...
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 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 ...
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) ...
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...
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...
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...
A study of 100 people with acute myeloid leukemia (AML) receiving chemotherapy found that patient and physician perceptions of treatment risk and the likelihood of a cure varied widely. Overall, patients tended to overestimate both the risk of dying due to treatment and the likelihood of a cure....
Bruno C. Medeiros, MD, of Stanford Cancer Institute, discusses emerging novel agents and targeted molecular abnormalities in the management of acute myeloid leukemia.
David G. Maloney, MD, PhD, of the Fred Hutchinson Cancer Research Center, reviews the clinical data and ongoing trials evaluating immunotherapy in the setting of relapsed or refractory acute lymphocytic leukemia and discusses major adverse events of treatment.
William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses sequencing therapy in patients with relapsed/refractory CLL/SLL based on prior treatment and the presence of cytogenetic abnormalities.
The phase III MURANO study of venetoclax (Venclexta) tablets in combination with rituximab (Rituxan) met its primary endpoint. Results showed that the combination prolonged progression-free survival in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) compared with bendamustine...
In a single-center phase II trial reported in JAMA Oncology, Jabbour et al found that the combination of inotuzumab ozogamicin (Besponsa) and low-intensity chemotherapy produced promising results in patients with relapsed or refractory Philadelphia chromosome (Ph)-negative acute lymphoblastic...
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 Kantarjian et al. Guadecitabine has a longer half-life and exposure...
The U.S. Food and Drug Administration (FDA) today approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug was also approved for the treatment of patients aged 2 years and older with...
Today, the U.S. Food and Drug Administration (FDA) issued what it has called a “historic action,” making the first gene therapy available in the United States. The FDA approved tisagenlecleucel (Kymriah) for certain pediatric and young adult patients with a form of acute lymphoblastic...
Vitamin C may “tell” faulty stem cells in the bone marrow to mature and die normally, instead of multiplying to cause blood cancers. This is the finding of a study led by researchers from Perlmutter Cancer Center at NYU Langone Health, and published by Cimmino et al in Cell....
In the phase III historically controlled Children’s Oncology Group (COG) AAML0631 trial, arsenic trioxide consolidation permitted the use of lower-dose anthracycline without appearing to compromise outcomes in pediatric patients with acute promyelocytic leukemia (APL). The results were...
On August 17, 2017, the U.S. Food and Drug Administration (FDA) approved inotuzumab ozogamicin (Besponsa) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). INO-VATE ALL The approval was based on data from INO-VATE ALL, a randomized (1:1), ...
As reported in the Journal of Clinical Oncology by Wang et al, many older patients with acute myeloid leukemia (AML) do not receive hospice care at the end of life, with those who do tending to enroll in hospice within days of death. Study Details The population-based retrospective cohort study...
On August 3, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) for the treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related...
Today, the U.S. Food and Drug Administration (FDA) approved enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which ...
An observational study reported in The Lancet Oncology by Wolthers et al in the Ponte di Legno Toxicity Working Group identified characteristics and the course of asparaginase-associated pancreatitis in childhood acute lymphoblastic leukemia. Study Details The study involved merged data from...
On July 28, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for venetoclax (Venclexta) in combination with low-dose cytarabine for elderly patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. FDA...
As reported by Turtle et al in the Journal of Clinical Oncology, anti-CD19 chimeric antigen receptor–modified (CAR) T-cell therapy produced high response rates in patients with chronic lymphocytic leukemia previously treated with ibrutinib (Imbruvica). Study Details In the phase I/II study, ...
In a Children’s Oncology Group (COG) study (AALL06N1) reported in the Journal of Clinical Oncology, Hardy et al found that age < 10 years at diagnosis was associated with poorer neurocognitive function in patients with high-risk B-lineage acute lymphoblastic leukemia regardless of...
In an analysis of the phase III Children’s Oncology Group AAML0531 trial, published by Lambda et al in the Journal of Clinical Oncology, the CD33-targeted immunoconjugate gemtuzumab ozogamicin was shown to have benefit among patients with de novo acute myeloid leukemia (AML) who carry the CC...
Today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss the biologics license application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy CTL019 (tisagenlecleucel) for the treatment of relapsed or refractory pediatric and young adult...
On July 11, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include overall survival data from the phase III TOWER study. The approval converts blinatumomab's accelerated approval to a full approval. The sBLA...
On July 10, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) to include an indication for dasatinib (Sprycel) to treat children with Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (CML), as well as a powder for oral...
A Korean phase III trial has shown no difference in outcomes with high-dose daunorubicin vs idarubicin induction in newly diagnosed acute myeloid leukemia, although high-dose daunorubicin was associated with better outcomes in patients with FLT3–internal tandem duplication (ITD) mutation....
In a phase III trial (Cancer and Leukemia Group B 10603 [RATIFY]/Alliance) reported in The New England Journal of Medicine, Stone et al found that the addition of midostaurin (Rydapt) to standard chemotherapy improved overall survival in patients with newly diagnosed acute myeloid leukemia with...
On June 29, the U.S. Food and Drug Administration (FDA) allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin...
New data from two clinical trials—ENESTfreedom and ENESTop—demonstrates that approximately half of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in the chronic phase, were able to maintain treatment-free remission after stopping treatment with ...
Updated results from the ELIANA clinical trial demonstrated CTL019 (tisagenlecleucel) remission rates are maintained at 6 months in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). These data from this pivotal trial of CTL019 show that 83% (52...
On June 22, 2017, the U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The approval provides a...
Seattle Genetics has discontinued its phase III CASCADE clinical trial of front-line vadastuximab talirine (SGN-CD33A) in older acute myeloid leukemia (AML) patients. The phase III CASCADE clinical trial is a randomized, double-blind, placebo-controlled study evaluating vadastuximab talirine...
Data was recently presented from the phase III GENUINE trial of ublituximab, a novel glycoengineered anti–CD20 monoclonal antibody, in combination with ibrutinib (Imbruvica), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of high-risk chronic lymphocytic leukemia (CLL), at the...
Data from the chemotherapy-free triple combination of umbralisib, an oral, next generation PI3K delta inhibitor; ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody; and ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and...
After phase I results of Seattle Children's Pediatric Leukemia Adoptive Therapy (PLAT-02) trial, published by Gardner et al in Blood, showed T-cell immunotherapy to be effective in sending 93% of patients with relapsed or refractory acute lymphoblastic leukemia (ALL) into complete initial...
On April 28, 2017, the U.S. Food and Drug Administration (FDA) approved midostaurin (Rydapt) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation–positive, as detected by an FDA-approved test, in combination with standard cytarabine and...
In a phase II trial reported in the Journal of Clinical Oncology, Martinelli et al found that blinatumomab (Blincyto) produced complete responses in patients with relapsed/refractory Philadelphia chromosome–positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) progressing after...
In a report from the Children’s Oncology Group Study AALL03N1 published in the Journal of Clinical Oncology, Landier et al found no association between oral mercaptopurine ingestion habits in children with acute lymphoblastic leukemia and risk of relapse after adjustment for medication...
In a substudy of a European phase III trial (Nordic Society of Pediatric Hematology and Oncology ALL2008) reported in The Lancet Oncology, Nygaard Nielsen et al found that higher leukocyte DNA-incorporated thioguanine nucleotide (DNA-TGN) levels were associated with an improved relapse-free...
Long-term follow-up of patients with chronic myeloid leukemia (CML) randomized to imatinib in the IRIS trial was reported by Hochhaus et al in The New England Journal of Medicine. In the open-label crossover-design trial, 1,106 patients with CML were randomized to receive imatinib at 400 mg/d (n = ...
In the phase III TOWER trial reported in The New England Journal of Medicine, Kantarjian et al found that blinatumomab (Blincyto) treatment improved overall survival vs chemotherapy in heavily pretreated patients with B-cell precursor acute lymphoblastic leukemia (ALL). Blinatumomab received...
In a French phase II trial reported in the Journal of Clinical Oncology, Thomas et al found that clofarabine-based consolidation may provide improved relapse-free survival vs conventional high-dose cytarabine in postremission treatment in younger patients with acute myeloid leukemia (AML) and no...