FDA Approves Rituximab Biosimilar for Non-Hodgkin Lymphoma, CLL, and Autoimmune Conditions
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....
Brentuximab Vedotin in Untreated Systemic Anaplastic Large-Cell Lymphoma and CD30-Expressing Peripheral T-Cell Lymphomas
On November 16, 2018, brentuximab vedotin was approved for use in combination with chemotherapy for previously untreated systemic anaplastic large-cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCLs), including angioimmunoblastic T-cell lymphoma and PTCL–not otherwise...
Long-Term Health Outcomes After Lymphome Malin de Burkitt Chemotherapy for Pediatric Mature B-Cell Non-Hodgkin Lymphoma
In a study reported in the Journal of Clinical Oncology, Ehrhardt et al found that long-term health outcomes were comparable in patients receiving contemporary Lymphome Malin de Burkitt (LMB) vs non-LMB chemotherapy regimens for pediatric mature B-cell non-Hodgkin lymphoma, except for adverse...
FDA Pipeline: Designations and Applications Granted in Lymphoma, Small Cell Lung Cancer, Multiple Myeloma, and More
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to a phospholipid-drug conjugate in diffuse large B-cell lymphoma; granted Orphan Drug designation to an immunotherapy for small cell lung cancer (SCLC); accepted supplemental biologics license applications (sBLAs) ...
Combination Therapy With Immunochemotherapy and an Antibody-Drug Conjugate in DLBCL
As reported in The Lancet Oncology, Hervé Tilly, MD, and colleagues found that the combination of polatuzumab vedotin, an antibody-drug conjugate targeting the CD79b component of the B-cell receptor, with immunochemotherapy showed high response rates in the phase II portion of a phase I/II study in ...
Anti-KIR3DL2 Monoclonal Antibody for Relapsed or Refractory Cutaneous T-Cell Lymphoma
In a phase I trial reported in The Lancet Oncology, Bagot et al found that IPH4102—a first-in-class monoclonal antibody targeting KIR3DL2—was safe and showed activity in patients with relapsed or refractory cutaneous T-cell lymphoma, particularly those with Sézary syndrome....
15-ICML: Adding Lenalidomide to R-CHOP in Newly Diagnosed DLBCL
In the phase II ECOG-ACRIN 1412 trial, presented by Nowakowski et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 006), researchers sought to compare the addition of lenalidomide to R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) vs...
15-ICML: Can Serum Biomarkers Provide Prognostic Information in Relapsed Mantle Cell Lymphoma?
Data presented by Lokhande et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 360) focused on noninvasive strategies to guide patient stratification for relapsed mantle cell lymphoma. Researchers used an antibody-based platform to identify serum proteins in patients...
FDA Pipeline: Applications Accepted in Gynecologic Cancers, Targeted Therapies
Recently, the U.S. Food and Drug Administration (FDA) accepted a new drug application for niraparib in the treatment of certain pretreated gynecologic cancers; granted Fast Track designation to a T-cell product; accepted investigational new drug applications for a myelopreservation agent and an...
15-ICML: Final Data From ALCANZA: Brentuximab Vedotin for CD30-Positive CTCL
Final analyses from the ALCANZA study, a phase III trial investigating brentuximab vedotin vs physician’s choice for the treatment of CD30-positive cutaneous T-cell lymphoma (CTCL), were presented by Horwitz et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract...
15-ICML: ROBUST Trial Examines Efficacy of Lenalidomide/R-CHOP in Previously Untreated ABC-Type DLBCL
The ROBUST trial compared the addition of lenalidomide to R-CHOP (rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone) vs placebo/R-CHOP in previously untreated, prospectively selected, CD20-positive patients with activated B-cell–like (ABC)-type diffuse large B-cell...
15-ICML: Genotyping of ctDNA in Classical Hodgkin Lymphoma
An abstract presented by Camus et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 138) found that targeted genotyping of circulating tumor DNA (ctDNA) in classical Hodgkin lymphoma at diagnosis “may help to assess early treatment response in complement to...
15-ICML: Post Hoc Analysis of MAVORIC Study: Mogamulizumab in Patients With Previously Treated Cutaneous T-Cell Lymphoma
The MAVORIC study—presented by Scarisbrick et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 034)—examined the efficacy of mogamulizumab, a monoclonal antibody that targets the CC chemokine receptor 4 (CCR4), in patients with previously treated mycosis...
15-ICML: Identifying Genetic Alterations Associated With Relapse in DLBCL
In an abstract presented by Rushton et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 004), researchers found that patients with diffuse large B-cell lymphoma (DLBCL) with specific mutations in relapse-enriched genes may be at a higher risk of treatment failure. The...
Transitioning From Healthy Physician to Patient With Cancer
As you probably already know, physicians do not make the best patients. When I began experiencing the early signs of Hodgkin lymphoma, in 2007, including a persistent cough, unusual fatigue, and pruritus, I self-diagnosed allergic rhinitis and began treatment with intranasal corticosteroids....
Rate and Outcome of Late Relapses in Patients With DLBCL Treated With Immunochemotherapy
In a study reported in the Journal of Clinical Oncology, Wang et al identified the rates and outcomes of relapses of diffuse large B-cell lymphoma (DLBCL) in patients who had achieved 24-month event-free survival (EFS) after immunochemotherapy. Study Details The study involved 1,324...
Cytoreductive Surgery for Primary Central Nervous System Lymphoma
Through a systematic review of published studies, researchers report they have identified a distinct subtype of primary central nervous system (PCNS) lymphoma that should be considered for surgical removal, suggesting a major shift in how this type of tumor is evaluated and managed. These findings...
CheckMate 205: Nivolumab in Newly Diagnosed, Advanced Classical Hodgkin Lymphoma
Findings in a cohort of the phase II CheckMate 205 study, reported in the Journal of Clinical Oncology by Ramchandren et al, indicate that nivolumab monotherapy followed by nivolumab plus doxorubicin, vinblastine, and dacarbazine (N-AVD) is highly active in newly diagnosed, advanced-stage classical ...
Prognostic Significance of PET Score in Early-Stage Hodgkin Lymphoma
In an analysis from the UK RAPID study reported in the Journal of Clinical Oncology, Barrington et al found that a postchemotherapy positron-emission tomography (PET) score of 5 was associated with poorer outcomes among patients with early-stage Hodgkin lymphoma. Study Details In the trial,...
FDA Approves Polatuzumab Vedotin-piiq in Combination With Bendamustine and a Rituximab Product for DLBCL
On June 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (Polivy), a CD79b-directed antibody-drug conjugate, in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma...
FDA Pipeline: Reviews and Designations in Multiple Myeloma, Lymphoma, Prostate Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review for daratumumab in combination with a triplet therapy in multiple myeloma, Breakthrough Therapy designation to copanlisib for marginal zone lymphoma, and Fast Track designation for ARV-110 in metastatic...
2019 ASCO: Rituximab, Lenalidomide, and Ibrutinib Prior to Chemotherapy in DLBCL
Results of the phase II Smart Start trial revealed that combination targeted therapy consisting of rituximab, lenalidomide, and ibrutinib had an 84.6% overall response rate (ORR) and 38.5% complete response rate (CRR) when given prior to any chemotherapy for newly diagnosed patients with a...
Jason Westin, MD, on Diffuse Large B-Cell Lymphoma: Rituximab, Lenalidomide, and Ibrutinib Prior to Chemotherapy
Jason Westin, MD, of The University of Texas MD Anderson Cancer Center, discusses findings of the Smart Start study on the chemotherapy-free combination of rituximab, lenalidomide, and ibrutinib in newly diagnosed diffuse large B-cell lymphoma (Abstract 7508).
William G. Wierda, MD, PhD, on Immunotherapy for Relapsed/Refractory CLL/SLL: Results From TRANSCEND CLL 004
William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses the TRANSCEND CLL 004 trial, which studied the use of an experimental CD19-directed CAR T-cell product in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (Abstract 7501).
Polatuzumab Vedotin and Immunochemotherapy in Previously Untreated Diffuse Large B-Cell Lymphoma
As reported in The Lancet Oncology, Tilly et al found that the combination of polatuzumab vedotin, an antibody-drug conjugate targeting the CD79b component of the B-cell receptor, with immunochemotherapy showed high response rates in the phase II portion of a phase I/II study in previously...
FDA Approves Lenalidomide in Combination for Previously Treated Follicular and Marginal Zone Lymphomas
Today, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid) in combination with a rituximab product for previously treated follicular and marginal zone lymphoma. AUGMENT and MAGNIFY Trials Approval was based on two clinical trials: AUGMENT and MAGNIFY. In AUGMENT, 358...
FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL
On May 15, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on the CLL14...
Combination Immunotherapy With Lenalidomide Plus Rituximab in Indolent NHL: Time to Replace Rituximab Monotherapy?
With increasing knowledge on the key role of the tumor microenvironment in lymphomagenesis, treatments for indolent B-cell lymphoma, especially follicular lymphoma, are mechanistically moving toward a more immunomodulatory approach. Chemotherapy-free regimens are an attractive alternative to...
AUGMENT Trial: Addition of Lenalidomide to Rituximab in Relapsed or Refractory Indolent Lymphoma
In the phase III AUGMENT trial, reported in the Journal of Clinical Oncology, John P. Leonard, MD, of Meyer Cancer Center, Weill Cornell Medicine and NewYork-Presbyterian Hospital, and colleagues found that the addition of lenalidomide to rituximab significantly prolonged progression-free survival...
FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL
The U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The approval is based on the results of the...
Addition of Decitabine to Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma
In a single-center phase II trial reported in the Journal of Clinical Oncology, Nie et al found a higher complete response rate with the addition of low-dose decitabine to the programmed cell death protein 1 (PD-1) inhibitor camrelizumab in anti–PD-1 treatment–naive patients with...
Expert Point of View: Louis M. Weiner, MD, and Thomas Habermann, MD
“THIS REPRESENTS the fruits of years of research. Umbralisib is a more potent and selective PI3K inhibitor targeted to the delta isoform. This provides a more precise target for drugs that block that protein, and it more effectively disables signaling. The B cell is central to the survival of...
Umbralisib: Potential Option for Relapsed or Refractory Marginal Zone Lymphoma
UMBRALISIB—an investigational PI3K-delta inhibitor—produced impressive results as monotherapy in patients with relapsed or refractory marginal zone lymphoma, according to an interim analysis of the phase II UNITY-NHL trial presented at the 2019 American Association for Cancer Research (AACR) Annual ...
ESTRO 38: Radiotherapy After ABVD May Improve Survival in Advanced Hodgkin Lymphoma
Patients with advanced Hodgkin lymphoma with bulky lesions at the time of diagnosis may benefit from radiotherapy after chemotherapy, according to late-breaking results presented by Ricardi et al at ESTRO 38, the annual congress of the European Society for Radiotherapy & Oncology...
Risk Model for Disease Progression in Asymptomatic Waldenström’s Macroglobulinemia
In a study reported in the Journal of Clinical Oncology, Bustoros et al developed a model for predicting risk of progression from asymptomatic Waldenström’s macroglobulinemia to symptomatic disease requiring treatment. The study involved 439 patients with asymptomatic...
Front-Line Dose-Adjusted EPOCH-R vs R-CHOP in Diffuse Large B-Cell Lymphoma
As reported in the Journal of Clinical Oncology by Bartlett et al, the phase III intergroup Alliance/CALGB 50303 trial showed front-line DA-EPOCH-R (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) did not improve outcomes vs standard R-CHOP...
Addition of Bortezomib to R-CHOP in DLBCL Subtypes Identified With Gene-Expression Profiling
In the phase III REMoDL-B trial reported in The Lancet Oncology, Davies et al found that the addition of bortezomib to standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone) did not improve progression-free survival subtypes of diffuse large B-cell lymphoma...
Addition of Ibrutinib to R-CHOP in Non–Germinal Center B-Cell DLBCL
In the phase III PHOENIX trial reported in the Journal of Clinical Oncology, Younes et al found that the addition of ibrutinib to R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) did not improve outcomes in patients with untreated non–germinal center B-cell...
AUGMENT: Addition of Lenalidomide to Rituximab in Relapsed or Refractory Indolent Lymphoma
In the phase III AUGMENT trial reported in the Journal of Clinical Oncology, Leonard et al found that the addition of lenalidomide to rituximab significantly prolonged progression-free survival in patients with relapsed or refractory indolent lymphoma. Study Details The double-blind trial...
Frederick L. Locke, MD, on Innovative CAR-T Cell Therapies: The Patient Experience
Frederick L. Locke, MD, of the H. Lee Moffitt Cancer Center and Research Institute, discusses recent approvals of chimeric antigen receptor T-cell therapies in leukemia and lymphoma, and how clinicians are using infrastructure, navigation, and early referrals to maximize response and minimize toxicity.
CAR T-Cell Therapy for DLBCL: At the Crossroads of Hype and Reality
In the 20-plus years I have spent in hematologic oncology, I have been fortunate to have a ringside seat to watch “game-changing” advances come into our field—all-trans retinoic acid for acute promyelocytic leukemia, tyrosine kinase inhibitors starting with imatinib for chronic myeloid leukemia,...
Tisagenlecleucel Active in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma
As reported in The New England Journal of Medicine by Stephen J. Schuster, MD, of Abramson Cancer Center, University of Pennsylvania, and colleagues, the international phase II JULIET trial has shown high response rates with the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel in...
Subsequent Primary Neoplasms in Survivors of Adolescent and Young Adult Cancers
In a UK population-based cohort study (Teenage and Young Adult Cancer Survivor Study) reported in The Lancet Oncology, Bright et al found that subsequent primary neoplasms were most common in survivors of adolescent and young adult (AYA) breast, cervical, and testicular cancers, as well as Hodgkin...
Update on Newer Treatments in Non-Hodgkin Lymphomas
AS PART of The ASCO Post’s continued coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, here is an update on several different studies on new therapeutics in non-Hodgkin lymphomas (NHLs), including follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), ...
FDA Pipeline: Updates on Treatments for Cervical Cancer, Myelofibrosis, Chemotherapy-Induced Nausea and Vomiting, and More
The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...
First-Line Treatment of Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma With Bendamustine/Rituximab vs R-CHOP or R-CVP
As reported in the Journal of Clinical Oncology by Flinn et al, 5-year follow-up of the phase III BRIGHT trial has shown improved outcomes with first-line bendamustine/rituximab vs R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) or R-CVP (rituximab plus...
Relapse Risk and Survival With Contemporary Therapy in Young Patients With Hodgkin Lymphoma
In a Nordic Lymphoma Epidemiology Group study reported in the Journal of Clinical Oncology, Biccler et al found that relapse risk and loss in expectation of lifetime were low in young patients receiving contemporary therapy for classical Hodgkin lymphoma. Outcomes were particularly good among...
Update on FDA-Approved CAR T-Cell Products
AXICABTAGENE CILOLEUCEL (also known as CAR19) is an anti-CD19 chimeric antigen receptor (CAR) T-cell product approved by U.S. Food and Drug Administration to treat selected hematologic malignancies.1 To appreciate the clinical trial findings summarized here, from selected abstracts presented at the ...
Update on FDA-Approved CAR T-Cell Products
TISAGENLECLEUCEL IS an anti-CD19 chimeric antigen receptor (CAR) T-cell product approved by U.S. Food and Drug Administration to treat selected hematologic malignancies.1,2 To appreciate the clinical trial findings summarized here, from selected abstracts presented at the 2018 American Society of...
Highlights From the 2018 ASH Annual Meeting & Exposition
TO ADD to our ongoing coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, we bring readers of The ASCO Post these summaries of an assortment of interesting studies. They focus on novel therapies under investigation in the treatment of acute lymphoblastic...
