Abstracts Clinical Lymphoma, Myeloma & Leukemia September 2023 S356 Cell Hematology and Hemostaseology, Leipzig University Hospital, Leipzig, Germany. 3MDS Unit, Hematology, University of Florence, AOUC, Florence, Italy. 4Department of Internal Medicine, Yale School of Medicine and Yale Cancer Center, Yale University, New Haven, CT, USA. 5Service d’Hématologie Séniors, Hôpital Saint-Louis, Université Paris 7, Paris, France. 6Moffitt Cancer Center, Tampa, FL, USA. 7Monash University and Monash Health, Melbourne, VIC, Australia. 8Hospital Universitari Vall d’Hebron, Barcelona, Spain. 9Medical Department Hematology, Charles University General University Hospital, Prague, Czech Republic. 10Hôpital Haut-Lévêque, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France. 11Malignant Haematology & Stem Cell Transplantation, The Alfred, Melbourne, VIC, Australia. 12Department of Laboratory Medicine, National Taiwan University Hospital, Taipei, Taiwan. 13Bristol Myers Squibb, Princeton, NJ, USA. 14Celgene International Sàrl, a Bristol-Myers Squibb Company, Boudry, Switzerland. 15Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. 16Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania. 17IRCCS University Hospital of Bologna, “Seràgnoli” Institute of Hematology, Bologna, Italy. 18Département d’Hématologie Clinique, Université Cote d’Azur, CHU Nice, Nice, France. 19Cancer Center IRCCS Humanitas Research Hospital, Milan, Italy. 20Department of Biomedical Sciences, Humanitas University, Milan, Italy Context: There is unmet need for effective treatment of LRMDS-associated anemia. Luspatercept is approved in the US and EU to treat anemia following ESA failure. Objective: To report interim efficacy and safety data from the COMMANDS trial (NCT03682536) comparing luspatercept with EA in patients with ESA‑naive transfusion-dependent (TD) LR-MDS. Patients: Eligible patients were aged ≥18 years, TD, and had serum erythropoietin (sEPO) <500 U/L. Interventions: Patients received subcutaneous luspatercept (1.0–1.75 mg/kg; Q3W) or EA (450–1050 IU/kg; Q1W) for ≥24 weeks. Patients were stratified by baseline RBC transfusion burden, baseline sEPO, and ring sideroblast (RS) status. Main Outcome Measures: Primary endpoint was RBC transfusion independence (RBC-TI) ≥12 weeks with concurrent mean hemoglobin increase ≥1.5 g/dL (weeks 1–24). Secondary endpoints included hematologic improvement-erythroid (HI-E) ≥8 weeks; RBC‑TI 24 weeks, and ≥12 weeks (weeks 1–24); and safety. Results: 178 patients were randomized to luspatercept, 178 to EA (per 31Aug2022); median treatment durations were 41.6 and 27.0 weeks, respectively. 86/147 (58.5%) luspatercept-treated and 48/154 (31.2%) EA-treated patients achieved primary endpoint (P<0.0001). Luspatercept treatment favored achievement of HI-E ≥8 weeks, RBC-TI 24 weeks, and RBC-TI ≥12 weeks. Median duration of RBC-TI ≥12 weeks (week 1 to end of treatment) was longer with luspatercept versus EA treatment (126.6 versus 77.0 weeks) and for subgroups, including RS+ and RS−. Treatment-emergent adverse events were reported in 164/178 (92.1%) luspatercept-treated and 150/176 (85.2%) EA-treated patients; most with luspatercept were grade 1/2 that did not lead to dose discontinuation. Ontreatment AML progression rates were 0.6% in each armand were 4/178 (2.2%) for luspatercept and 5/176 (2.8%) for EA overall, including the post-treatment period. On-treatment rates of death were similar between arms (11/178 [6.2%] luspatercept-treated versus 12/178 [6.8%] EA-treated patients), and overall, including the post-treatment period, were 32/178 [18.0%] luspatercepttreated versus 32/176 [18.2%] EA-treated patients). Conclusions: Almost twice as many patients achieved RBC-TI and hemoglobin increase with luspatercept versus EA; luspatercept delivered more durable responses and clinical benefit regardless of subgroups, with a manageable safety profile and no new safety signals. Luspatercept is the first therapy demonstrating superiority against ESAs. Keywords: MDS, myelodysplastic neoplasms, anemia, hemoglobin, RBC transfusion independence, ESA-naive, Phase III MDS-195 Characterization of Patients With Co‑Occurrent Clonal Myeloid and Plasma Cell Disorders: A Single Center Descriptive Case Series Michael Hochman MD1,2, Gloria Gerber MD2, Phil Imus MD1, Syed Abbas Ali MBBS1, Amy DeZern MD, MS1 1Division of Hematological Malignancies and Bone Marrow Transplantation, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA. 2Division of Hematology, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA Context: The development of clinically significant cytopenias in clonal myeloid and plasma cell disorders can warrant treatment. In patients with co-occurrence of these diseases (eg, both myelodysplastic neoplasms [MDS] and monoclonal gammopathy of undetermined significance [MGUS]), the culprit clonal disease may not be clear, and management presents a unique clinical challenge. Objective: To characterize the demographic/clinical features and treatment course of a cohort of patients with co-occurrent clonal myeloid and plasma cell disorders. Design: Descriptive retrospective study of single center patient cohort from 2017 to 2022. Setting: Academic medical center. Patients or Other Participants: Patients diagnosed with concurrent clonal myeloid (clonal cytopenia of undetermined significance, MDS, or chronic myelomonocytic leukemia) and plasma cell (MGUS or smoldering multiple myeloma) disorders. Main Outcome Measures: Diagnosis age, autoimmune disease and exposure history, family history of hematologic disease, clinical course. Results: Seventeen patients were identified with cooccurrent clonal myeloid and plasma cell disorders. The median diagnosis ages were 64 and 62 years for myeloid and plasma cell disorders, respectively. Most patients (13/17) were evaluated for hematologic disease due to incidentally discovered cytopenias. Seven patients had a history of autoimmune disease and nine had significant exposures, most often tobacco. Seven patients received therapy only directed to their myeloid process with generally favorable responses. Three were observed without therapy. Two patients received lenalidomide for MDS with deletion 5q, which may have incidentally treated the accompanying plasma cell clone. One patient responded to vitamin B12 repletion for her anemia. The remaining 3 patients received therapies intentionally directed at both clones at different time points. Conclusions: Patients with a co-occurrent myeloid neoplasm and plasma cell dyscrasia
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