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Over the past month, the U.S. Food and Drug Administration (FDA) has granted Priority Review to therapies for multiple myeloma, cervical cancer, chemotherapy-induced neutropenia, and myelofibrosis. The FDA also granted a number of Breakthrough Therapy designations, including those for treatments in ...
As reported in the Journal of Clinical Oncology by Paul G. Richardson, MD, and colleagues, the final overall survival analysis of the phase III TOURMALINE-MM1 trial showed no overall survival benefit with the addition of ixazomib to lenalidomide/dexamethasone (Rd) in relapsed or refractory multiple ...
As reported in The Lancet by Philippe Moreau, MD, and colleagues, the phase III IKEMA trial has shown that the addition of the anti-CD38 antibody isatuximab-irfc to carfilzomib and dexamethasone resulted in significantly improved progression-free survival in patients with relapsed or refractory...
In an updated analysis of the phase III MAIA trial, the addition of daratumumab to lenalidomide and dexamethasone resulted in a statistically significant overall survival benefit over lenalidomide/dexamethasone alone in patients with newly diagnosed multiple myeloma who are ineligible for...
As reported in The Lancet Oncology by Meletios A. Dimopoulos, MD, and colleagues, the phase III APOLLO trial has shown significantly improved progression-free survival with the addition of subcutaneous daratumumab to pomalidomide/dexamethasone in patients with previously treated multiple myeloma....
Taiga Nishihori, MD, of the H. Lee Moffitt Cancer Center and Research Institute, discusses the outcome of a trial that explored maintenance therapy with ixazomib after allogeneic hematopoietic cell transplantation in patients with high-risk multiple myeloma. Toxicities unrelated to the maintenance treatment forced the trial to close prematurely (Abstract 7003).
On March 26, 2021, idecabtagene vicleucel was approved for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.1,2 Idecabtagene vicleucel is...
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 February 26, 2021, the peptide-conjugated alkylating...
In the phase II Hovon 143 trial reported in the Journal of Clinical Oncology, Stege et al found that a regimen of ixazomib, daratumumab, and low-dose dexamethasone (Ixa-Dara-dex) was associated with a high response rate in frail patients with newly diagnosed multiple myeloma, but also a high rate...
Results from the single-institution phase II MANHATTAN study were reported in JAMA Oncology recently by Ola Landgren, MD, PhD, and colleagues. The investigators found that daratumumab in combination with weekly carfilzomib, lenalidomide, and dexamethasone resulted in high rates of minimal residual...
"The noblest pleasure is the joy of understanding.” —Leonardo da Vinci To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel...
Two new studies published in the journal Blood suggest that the BNT162b2 mRNA COVID-19 vaccine may have reduced efficacy in individuals with chronic lymphocytic leukemia (CLL) and multiple myeloma. According to researchers, these studies could help inform the ideal time for vaccination of these...
A study published by Oben et al in Nature Communications has shown that whole-genome sequencing can help determine which patients with a multiple myeloma precursor condition known as monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma may be at risk for progression to...
On March 31, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. IKEMA The efficacy...
On March 26, the U.S. Food and Drug Administration (FDA) approved idecabtagene vicleucel (Abecma) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 ...
Shaji K. Kumar, MD, of the Mayo Clinic Cancer Center, discusses the latest data on treating patients with multiple myeloma, including standard-of-care induction before stem cell transplant; the role of quadruplet induction; long-term results with the combination of daratumumab, lenalidomide, and dexamethasone in those who are ineligible for stem cell transplant; CAR T-cell engagers; and the need for more research on how immunotherapy fits in the sequence of treatments.
The combination of lenalidomide plus the steroid dexamethasone (together called Rd) is considered standard treatment for elderly patients with multiple myeloma. However, prolonged steroid use can be harmful for some older adults. A new study published by Larocca et al in the journal Blood found...
Belantamab mafodotin-blmf combined with pomalidomide and dexamethasone led to a very good partial response or better in approximately three-quarters of patients with multiple myeloma that was double-class or triple-class refractory, according to Suzanne Trudel, MSc, MD, FRCPC, of Princess Margaret...
As reported in The Lancet by Sebastian Grosicki, MD, of the Medical University of Silesia, Katowice, Poland, and colleagues, the phase III BOSTON trial has shown significantly prolonged progression-free survival with once-weekly selinexor plus bortezomib/dexamethasone vs twice-weekly...
In the pivotal phase II KarMMa study reported in The New England Journal of Medicine, Nikhil C. Munshi, MD, and colleagues found that the B-cell maturation antigen–directed chimeric antigen receptor (CAR) T-cell therapy idecabtagene vicleucel produced high response rates in patients with...
On February 26, the U.S. Food and Drug Administration (FDA) granted accelerated approval to melphalan flufenamide (Pepaxto) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is...
Recommendations designed to address the underrepresentation of Black patients in clinical trials for multiple myeloma were recently released. Details about the initiative, published by Gormley et al in Blood Cancer Discovery, form a road map for designing multiple myeloma clinical trials to...
A post hoc analysis of the phase II DREAMM-2 trial showed single-agent belantamab mafodotin-blmf to be efficacious and tolerable in patients with relapsed or refractory multiple myeloma treated with at least three prior therapies, investigators reported at the 2020 American Society of Hematology...
Belantamab mafodotin-blmf combined with pomalidomide and dexamethasone led to a very good partial response (VGPR) or better in approximately three-quarters of patients with multiple myeloma that was double-class or triple-class refractory, according to Suzanne Trudel, MSc, MD, FRCPC, of Princess...
Ajay K. Nooka, MD, MPH, FACP, Associate Professor of Hematology and Medical Oncology at Emory University and Medical Director, Winship Research Informatics Shared Resource at Winship Cancer Institute, Atlanta, considered the presentations on bispecific T-cell–engaging antibodies in myeloma to be...
B-cell maturation antigen (BCMA) is the most frequent target of immunotherapies in relapsed or refractory multiple myeloma, but bispecific T-cell–engaging antibodies with novel targets are also achieving promising results. Studies presented at the 2020 American Society of Hematology (ASH) Annual...
Sagar Lonial, MD, FACP, the Anne and Bernard Gray Family Chair in Cancer, Chair and Professor of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, commented on the APOLLO trial for The ASCO Post. “APOLLO is a highly awaited study, as the use of daratumumab plus...
The first phase III study to evaluate the subcutaneous form of daratumumab has met its primary endpoint, investigators of the APOLLO trial reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1 The triplet of daratumumab, pomalidomide, and low-dose dexamethasone ...
Selinexor: On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor (Xpovio) in combination with bortezomib (Velcade) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Venetoclax: On October 16,...
The world of hematologic malignancies continues to move forward at a robust pace despite the challenges of the COVID era. Although some areas of clinical trials and basic research suffered short-term stoppages or delays due to the pandemic, the studies presented at the 2020 American Society of...
In a policy review reported in The Lancet Oncology, Terpos et al presented updated recommendations from the Bone Working Group of the International Myeloma Working Group on the treatment of multiple myeloma–related bone disease. The recommendations cover: bisphosphonate use/dosing and management of ...
In an analysis of the phase III POLLUX and CASTOR trials reported in the Journal of Clinical Oncology, Avet-Loiseau et al found that the addition of daratumumab to standard therapy was associated with higher rates of—and more prolonged—measurable residual disease (MRD) negativity in patients with...
“Knowledge has a beginning but no end.” —Geeta Iyengar To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are three abstracts selected from the meeting proceedings focusing on novel therapies for...
The studies of ALLO-715 “off-the-shelf” CAR T-cell therapy and bb21217 impressed two experts in the field. Sagar Lonial, MD, the Anne and Bernard Gray Family Chair in Cancer, Chair and Professor of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, and Adam D. Cohen, MD, ...
In the treatment of relapsed or refractory multiple myeloma, chimeric antigen receptor (CAR) T-cell therapies with unique characteristics, still targeting B-cell maturation antigen (BCMA), are looking promising. At the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition,...
As reported in The Lancet Oncology by Shaji K. Kumar, MD, of the Division of Hematology, Mayo Clinic, Rochester, 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...
IFM 2009 showed that autologous stem cell transplant (ASCT) combined with lenalidomide, bortezomib, and dexamethasone (RVd) results in a significantly better progression-free survival than RVd alone in newly diagnosed patients with myeloma.1 “The data favor immediate ASCT, as transplant resulted in ...
The benefit of autologous transplantation in newly diagnosed multiple myeloma has been confirmed by follow-up of the IFM 2009 trial, reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition by Aurore Perrot, MD, PhD, Assistant Professor of Hematology at the Cancer...
On December 18, 2020, selinexor was approved for use in combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma who have received at least one prior therapy.1,2 Selinexor received accelerated approval in 2019 for use in combination with dexamethasone for...
A post hoc analysis of the phase II DREAMM-2 trial showed single-agent belantamab mafodotin-blmf to be efficacious and tolerable in patients with relapsed or refractory multiple myeloma treated with at least three prior therapies, investigators reported at the 2020 American Society of Hematology...
Ajay K. Nooka, MD, MPH, Associate Professor of Hematology and Medical Oncology at Emory University and Medical Director, Winship Research Informatics Shared Resource at Winship Cancer Institute, Atlanta, considered the presentations on bispecific T-cell–engaging antibodies in myeloma to be among...
B-cell maturation antigen (BCMA) is the most frequent target of immunotherapies in relapsed or refractory multiple myeloma, but bispecific T-cell–engaging (BiTE) antibodies with novel targets are also achieving promising results. Studies presented at the 2020 American Society of Hematology (ASH)...
Sagar Lonial, MD, the Anne and Bernard Gray Family Chair in Cancer, Chair and Professor of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, commented on the APOLLO trial for The ASCO Post. “APOLLO is a highly awaited study, as the use of daratumumab plus...
The first phase III study to evaluate the subcutaneous form of daratumumab has met its primary endpoint, investigators of the APOLLO trial reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1 The triplet of daratumumab, pomalidomide, and low-dose dexamethasone ...
Lena E. Winestone, MD, MSHP, of the University of California, San Francisco and Benioff Children’s Hospital, reviews different aspects of bias in treatment delivery, including patient selection for clinical trials; racial and ethnic disparities in survival for indolent non-Hodgkin diffuse large B-cell lymphomas; and end-of-life hospitalization of patients with multiple myeloma, as well as outcome disparities (Abstracts 207-212).
In an analysis from the phase III MAIA trial reported in the Journal of Clinical Oncology, Perrot et al found that the combination of daratumumab, lenalidomide, and dexamethasone (D-Rd) was associated with better health-related quality-of-life outcomes vs lenalidomide and dexamethasone (Rd) in...
Multiple myeloma is the second most common blood cancer, after non-Hodgkin lymphoma, diagnosed in the United States. In 2020, it is estimated that about 32,270 people will be diagnosed with the cancer, and despite advances in more effective treatments, nearly 13,000 will die of the disease.1...
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor (Xpovio) in combination with bortezomib (Velcade) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The FDA granted selinexor accelerated...
In the phase II HORIZON study reported in the Journal of Clinical Oncology, Paul G. Richardson, MD, and colleagues found that the combination of the peptide-drug conjugate melflufen and dexamethasone showed activity in patients with heavily pretreated relapsed and refractory multiple myeloma....