Ten-Year Outcomes after CAR T-Cell Therapy for B-Cell Lymphomas
After 10 years one third of the heavily pretreated lymphoma patients who had CAR-T therapy stayed disease free.
Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study
Author(s): David Belada1; Katerina Kopeckova2; Juan Miguel Bergua Burgues3; Don Stevens4; Marc André5; Ernesto Perez Persona6,7; Petra Pichler8,9; Philipp B. Staber10; Marek Trneny11; Johannes Duell12; Maeve Waldron-Lynch13; Steve Wagner14; Amitava Mukhopadhyay14; Maren Dirnberger-Hertweck14; John M. Burke15; Grzegorz S. Nowakowski16;
Source: Blood (2023) 142 (16): 1348–1358
Dr. Maen Hussein's Thoughts
Speaking of tafatistamab, it seems it is fairly tolerable in first line with almost 75% CR added to RCHOP, adding lenolidomie 86% CR, but this is a phase 1b. Awaiting phase 3 data, we may have another first line option or may the first line option.
KEY POINTS
- The novel combination of tafasitamab ± lenalidomide + R-CHOP showed signs of efficacy in patients with untreated DLBCL, with no new safety signals.
- The results, including a post hoc analysis in patients with high-risk disease (IPI 3-5), support the ongoing phase 3 frontMIND trial.
VISUAL ABSTRACT
ABSTRACT
Anti-CD19 immunotherapy tafasitamab is used in combination with lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant. Open-label, phase 1b, First-MIND study assessed safety and preliminary efficacy of tafasitamab + R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) ± lenalidomide as first-line therapy in patients with DLBCL. From December 2019 to August 2020, 83 adults with untreated DLBCL (International Prognostic Index 2-5) were screened and 66 were randomly assigned (33 per arm) to R-CHOP-tafasitamab (arm T) or R-CHOP-tafasitamab-lenalidomide (arm T/L) for 6 cycles. Primary end point was safety; secondary end points included end-of-treatment (EoT) overall response rate (ORR) and complete response (CR) rate. All patients had ≥1 treatment-emergent adverse event, mostly grade 1 or 2. Grade ≥3 neutropenia and thrombocytopenia occurred, respectively, in 57.6% and 12.1% (arm T) and 84.8% and 36.4% (arm T/L) of patients. Nonhematologic toxicities occurred at similar rates among arms. R-CHOP mean relative dose intensity was ≥89% in both arms. EoT ORR was 75.8% (CR 72.7%) in arm T and 81.8% (CR 66.7%) in arm T/L; best ORR across visits was 90.0% and 93.9%. Eighteen-month duration of response and of CR rates were 72.7% and 74.5% (arm T) and 78.7% and 86.5% (arm T/L); 24-month progression-free and overall survival rates were 72.7% and 90.3% (arm T) and 76.8% and 93.8% (arm T/L). Manageable safety and promising signals of efficacy were observed in both arms. Potential benefit of adding tafasitamab + lenalidomide to R-CHOP is being investigated in phase 3 frontMIND (NCT04824092). This study is registered at www.clinicaltrials.gov as #NCT04134936.Author Affiliations
14th Department of Internal Medicine—Hematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic; 2Department of Oncology of the 2nd Faculty of Medicine of Charles University and University Hospital in Motol, Prague, Czech Republic; 3Department of Hematology, Hospital San Pedro de Alcantara, Cáceres, Spain; 4Norton Cancer Institute—St. Matthews Campus, Louisville, KY; 5Department of Hematology, Université Catholique de Louvain, CHU UCL Namur, Yvoir, Belgium; 6Bioaraba (Onco-hematology Research Group), Vitoria-Gasteiz, Spain; 7Department of Hematology, Osakidetza Basque Health Service, Araba University Hospital, Vitoria-Gasteiz, Spain; 8Department of Internal Medicine, University Hospital of St. Pölten, St. Pölten, Austria; 9Karl Landsteiner University of Health Sciences, Karl Landsteiner Institute for Nephrology and Hemato Oncology, St. Pölten, Austria; 10Division of Hematology and Hemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria; 11Charles University General Hospital, Prague, Czech Republic; 12Medizinische Klinik und Poliklinik II, Universitätsklinik Würzburg, Würzburg, Germany; 13MorphoSys US Inc, Boston, MA; 14MorphoSys AG, Planegg, Germany; 15US Oncology Research and Rocky Mountain Cancer Centers, Aurora, CO; 16Division of Hematology, Mayo Clinic, Rochester, MNRelated Articles
Tafasitamab plus lenalidomide and R-CHOP versus R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma (frontMIND): a global, phase 3, randomised, double-blind, placebo-controlled trial
Progression-free survival was improved in the tafa-len-R-CHOP group vs the R-CHOP with 2-year progression-free survival rates of 71·1vs 62·9% toxicity was higher with tafa-len-R-CHOP with a higher rate of fatal treatment-emergent adverse events, but more overall deaths the RCHOP arm. It is early to add Len taf because of toxicity esp with OS survival and deep response data being immature.
BRUIN CLL-313: Randomized Phase III Trial of Pirtobrutinib Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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Mosunetuzumab Plus Polatuzumab Vedotin in Transplant-Ineligible Refractory/Relapsed Large B-Cell Lymphoma: Primary Results of the Phase III SUNMO Trial
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Five-Year Outcomes of the POLARIX Study Comparing Pola-R-CHP and R-CHOP in Patients With Diffuse Large B-Cell Lymphoma
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