Epogen (epoetin alfa) / Amgen - LARVOL DELTA

Resolution of Clonal Cytopenia of Undetermined Significance Following Autologous Stem Cell Boost in a Patient with Multiple Myeloma: A Case Report (IMS 2026) - "He received bortezomib, lenalidomide, and dexamethasone induction and autologous stem cell transplant consolidation with melphalan prep followed by stem cell rescue utilizing 6.32 x 10^6 CD34+ cells/kg...He remained transfusion dependent despite supportive care including epoetin alfa and romiplostim... This case suggests that autologous stem cell boost may represent a potential treatment option for select patients with CCUS and refractory cytopenias, a population for whom no established disease ‑ modifying therapies currently exist. These findings support consideration of early collection and storage of additional autologous stem cells when available. Stem cell boost may provide a valuable salvage strategy in certain clinical settings."

Case report • Clinical • IO biomarker • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • CD34

Preemptive Tocilizumab in Patients with Relapsed-Refractory Multiple Myeloma Receiving Bispecific: A Case Series (IMS 2026) - "Teclistamab (Tec), talquetamab (Tal), and elranatamab (Elra) are bispecific antibodies (BsAbs) approved for relapsed-refractory multiple myeloma (RRMM)...All patients received intravenous immunoglobulin to maintain functional IgG ≥500 mg/dL, filgrastim to maintain absolute neutrophil 1.00 K/mcL, epoetin alfa to maintain hemoglobin above 10 g/dL, and romiplostim to maintain platelets above 50 K/mcL...The only incident of CRS occurred with a single patient who developed grade 1 CRS on C1D3 which resolved after one dose of dexamethasone 10 mg... Preemptive Toci may decrease the incidence and severity of CRS in patients with RRMM receiving BsAbs, without compromising response. In this small observational analysis, no patients experienced prolonged hospitalization for management of CRS."

Bispecific • Clinical • Hematological Malignancies • Infectious Disease • Multiple Myeloma

Longitudinal Safety of Luspatercept in the Treatment of Anemia in Patients with Myelofibrosis: Results from the ACE-536-MF-001 Study (ASH 2023) - P2 | "Methods Pts were enrolled into 4 cohorts based on transfusion dependence (TD) and stable ruxolitinib (RUX) treatment – cohort 1: NTD, no RUX; cohort 2: TD, no RUX; cohort 3A: NTD, RUX; cohort 3B: TD, RUX...Results In the safety population (N = 95; cohort 1, n = 22; cohort 2, n = 14; cohort 3A, n = 21; cohort 3B, n = 38), the most frequently used prior medications for anemia treatment were erythropoiesis-stimulating agents (23.2%, most frequently epoetin alfa [14.7%]), followed by danazol (11.6%), lenalidomide (2.1%), and thalidomide (1.1%)...In addition to benefits in anemia, the safety profile of LUSPA allowed most pts receiving RUX to maintain or increase their RUX dose, supporting maintenance of Janus kinase inhibitor therapy for adequate disease control of MF. Study support: Bristol Myers Squibb."

Clinical • Anemia • Beta-Thalassemia • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Inflammation • Ischemic stroke • Musculoskeletal Pain • Myelodysplastic Syndrome • Myelofibrosis • Oncology • Pain • Pneumonia • Renal Disease • Respiratory Diseases • Septic Shock

A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov) - P2 | N=270 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Sep 2026 ➔ Dec 2026

Trial initiation date • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

NCI-2009-01173: Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (clinicaltrials.gov) - P3 | N=247 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2026 ➔ May 2027

Trial completion date • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

[VIRTUAL] The Commands Trial: A Phase 3 Study of the Efficacy and Safety of Luspatercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low-, Low-, or Intermediate-Risk MDS in Erythropoiesis Stimulating Agent-Naive Patients Who Require RBC Transfusions (ASH 2020) - P3 | "Recent studies of epoetin alfa and darbepoetin alfa have demonstrated efficacy among patients with LR-MDS, but the patient population in whom a clinically significant effect is seen may be limited (Fenaux P, et al...Exclusion criteria include prior use of ESAs (≤ 2 doses of prior epoetin alfa permitted if ≥ 8 weeks from randomization date and sEPO confirmed as ≤ 500 U/L), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF), unless given for the treatment of febrile neutropenia; disease-modifying agents (e.g. lenalidomide), or hypomethylating agents; and presence of del(5q) cytogenetic abnormality...Key secondary endpoints include duration of RBC-TI, change in Hb levels, achievement of HI-E response per International Working Group (IWG) 2006 criteria, and safety. The COMMANDS trial is registered at ClinicalTrials.gov (NCT03682536) and EudraCT (number 2017-003190-34)."

Clinical • P3 data • Anemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • CSF2 • EPO • SF3B1

A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov) - P2 | N=270 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Jun 2026 ➔ Sep 2026

Trial initiation date • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

Combining ESA and Luspatercept in Non-RS MDS Patients Having Failed ESA - Results of the Phase 1-2 Part a of the GFM Combola Study (ASH 2024) - "Based on a TITE-BOIN-ET design, Epoetin alfa was administered weekly at dose concentrations ranging from 30 000UI to 60 000 UI...All patients had resistance to ESA and 7 had also received Revlimid (n=3), IDH inhibitors (n=2), Thalidomide (n=1), AZA (n=1)...Based on the results of this Phase 1 study, the dosing schedule Luspatercept 1.75 mg/kg/21d and EPO 60 000 UI/w, that balanced clinical efficacy and safety profile was selected as the RP2D. This regimen is being compared to Luspatercept 1.75 mg/kg/21d in the ongoing randomized Phase 2 study."

Clinical • P1/2 data • Anemia • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Myelodysplastic Syndrome

Iron-Clad Care for Neonates: Precision Iron Supplementation Using Reticulocyte Hemoglobin Values, a Quality Improvement Project. (PubMed, Adv Neonatal Care) - "Further research is needed to determine whether Ret-He values should differ for specific gestational ages or high-risk populations, such as small-for-gestational-age infants. Additional knowledge is needed on maximum iron doses and duration of intake."

Journal • Alzheimer's Disease • Cognitive Disorders • Critical care • Hematological Disorders • Small for Gestational Age

Efficacy and safety results from the COMMANDS trial: A phase 3 study evaluating luspatercept vs epoetin alfa in erythropoiesis-stimulating agent (ESA)‑naive transfusion-dependent (TD) patients (pts) with lower‑risk myelodysplastic syndromes (LR-MDS). (ASCO 2023) - P3 | "Compared with epoetin alfa, luspatercept led to clinically meaningful and statistically significant improvements in RBC-TI and erythroid response, as well as duration of response. Luspatercept safety results were consistent with previous findings. These data show, for the first time, superiority of an innovative therapy over ESAs in ESA-naive pts with TD LR-MDS."

Clinical • P3 data • Acute Myelogenous Leukemia • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

LUSPATERCEPT VERSUS EPOETIN ALFA FOR TREATMENT (TX) OF ANEMIA IN ESA-NAIVE LOWER-RISK MYELODYSPLASTIC SYNDROMES (LR-MDS) PATIENTS (PTS) REQUIRING RBC TRANSFUSIONS: DATA FROM THE PHASE 3 COMMANDS STUDY (EHA 2023) - P3 | "Luspatercept demonstrated superiority over epoetin alfa with clinically meaningful improvements in RBC-TIand HI-E rates in ESA-naiveLR-MDS pts who requiretransfusions.Luspatercept showed morefavorable outcomes compared to epoetin alfa across a spectrum of known MDS mutations.Luspatercept safety profile was comparable with previous reports; no new safety events wereidentified.Luspatercept may transform thecurrent landscape by establishing a new standard of tx for ESA-naive pts with transfusion dependent LR-MDS. Keywords: Mutation analysis, Myelodysplastic syndrome,Erythropoieisis, Clinical trial"

Clinical • P3 data • Tumor mutational burden • Acute Myelogenous Leukemia • Anemia • Cardiovascular • Fatigue • Hematological Disorders • Hematological Malignancies • Hypertension • Myelodysplastic Syndrome • Oncology • ASXL1 • DNMT3A • IDH2 • SF3B1 • TET2 • TMB • U2AF1

Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial. (PubMed, Lancet) - P3 | "In this interim analysis, luspatercept improved the rate at which red blood cell transfusion independence and increased haemoglobin were achieved compared with epoetin alfa in ESA-naive patients with lower-risk myelodysplastic syndromes. Long-term follow-up and additional data will be needed to confirm these results and further refine findings in other subgroups of patients with lower-risk myelodysplastic syndromes, including non-mutated SF3B1 or ring sideroblast-negative subgroups."

Journal • P3 data • P3 data: top line • Acute Myelogenous Leukemia • Cardiovascular • Fatigue • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Novel Coronavirus Disease • Oncology • Pain • Pneumonia • Pulmonary Disease • Respiratory Diseases • Thrombocytopenia • SF3B1

Patient-Reported Outcomes (PRO) of Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent (ESA)-Naïve, Transfusion-Dependent (TD), Lower-Risk Myelodysplastic Syndromes (LR-MDS): Results from the Phase 3 COMMANDS Study (ASH 2023) - "The findings from these interim PRO analyses indicate that treatment with luspatercept increased sustained improvement across quality-of-life domains when compared to epoetin alfa. Luspatercept was also found to be well-tolerated by the majority of patients. All of these PRO findings further support the benefits of luspatercept in ESA-naïve and TD patients with LR-MDS."

Clinical • P3 data • Patient reported outcomes • Anemia • Anorexia • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Insomnia • Myelodysplastic Syndrome • Oncology • Pulmonary Disease • Sleep Disorder

Efficacy and Safety of Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent (ESA)-Naive Patients (Pts) with Transfusion-Dependent (TD) Lower-Risk Myelodysplastic Syndromes (LR-MDS): Full Analysis of the COMMANDS Trial (ASH 2023) - P3 | "Results of this full analysis confirm the findings from the interim analysis; RBC-TI duration and erythroid responses achieved with luspatercept are superior compared with epoetin alfa. Luspatercept safety results were consistent with previous MDS studies. These data show that luspatercept could represent a new standard of care for pts with TD LR-MDS."

Clinical • Acute Myelogenous Leukemia • Anemia • Cardiovascular • Fatigue • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Novel Coronavirus Disease • Oncology • SF3B1

Luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): primary analysis of a phase 3, open-label, randomised, controlled trial. (PubMed, Lancet Haematol) - P3 | "Luspatercept represents a new standard of care for ESA-naive patients with transfusion-dependent, lower-risk myelodysplastic syndromes. Significantly more patients had red blood cell transfusion independence and haematological improvement with luspatercept than with epoetin alfa, with benefits observed across patient subgroups."

Journal • P3 data • Acute Myelogenous Leukemia • Cardiovascular • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Novel Coronavirus Disease • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Thrombocytopenia

Long-Term Response Analysis of Transfusion Independence in Erythropoiesis Stimulating Agent–Naive Patients with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes Treated with Luspatercept Vs Epoetin Alfa in the COMMANDS Trial (ASH 2024) - P3 | "Progression rates to high-risk MDS and AML were low in both treatment arms. These data support luspatercept as the treatment of choice in TD ESA-naive pts with lower-risk MDS."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • SF3B1

Overall survival (OS) and duration of response for transfusion independence (TI) in erythropoiesis stimulating agent (ESA)–naive patients (pts) with very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS) treated with luspatercept (LUSPA) vs epoetin alfa (EA) in the COMMANDS trial. (ASCO 2025) - P3 | "LUSPA led to improvements in response rate and duration, with a positive OS trend requiring further evaluation through more extended follow up. LUSPA signifies a new standard of care for anemia in first-line LR-MDS. ITT, intention-to-treat; U, units."

Clinical • Acute Myelogenous Leukemia • Anemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

OVERALL SURVIVAL AND DURATION OF TRANSFUSION INDEPENDENCE FOR FIRST-LINE ESA-NAIVE PATIENTS WITH LOWER-RISK MYELODYSPLASTIC SYNDROMES TREATED WITH LUSPATERCEPT VS EPOETIN ALFA IN THE COMMANDS TRIAL (EHA 2025) - P3 | "Luspatercept treatment resulted in a clinically meaningful and statistically significant longer duration of response compared with epoetin alfa. There was a positive OS trend compared with epoetin alfa, which was consistent across all subgroups, and no new safety concerns. Longer follow up is required to confirm these data."

Clinical • Acute Myelogenous Leukemia • Anemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Clinical benefit of luspatercept in erythropoiesis-stimulating agent (ESA)-naive patients (pts) with early disease characteristics and very low-, low-, or intermediate-risk Myelodysplastic Syndromes (LR-MDS): A post hoc analysis from the commands trial (ASH 2025) - P3 | "Background :In the phase 3 COMMANDS trial (NCT03682536) evaluating pts with ESA-naive transfusion-dependent(TD) LR-MDS, luspatercept was superior to epoetin alfa (EA) in achieving red blood cell-transfusionindependence (RBC-TI) ≥12 weeks (wks) and demonstrated a more durable clinical benefit. Pts with less severe disease characteristics, reflective of an earlier disease stage, derive greater clinicalbenefit from treatment than those with more advanced characteristics. Pts on luspatercept vs EAdemonstrated higher response rates and longer duration of response regardless of disease stage, furthersupporting its role as a preferred first-line therapy in LR-MDS."

Clinical • Retrospective data • Hematological Malignancies • Myelodysplastic Syndrome

Impact of Mutational Landscape and Burden on RBC Transfusion Response in Patients With Lower-Risk Myelodysplastic Syndromes (LR-MDS) in the COMMANDS Study. (PubMed, Am J Hematol) - P3 | "Here we report red blood cell (RBC) transfusion response analysis based on somatic mutations profile and disease risk for patients treated with luspatercept or epoetin alfa in the COMMANDS trial. Luspatercept represents an effective treatment option in various mutational backgrounds in LR MDS. Trial Registration: ClinicalTrials.gov Identifier: NCT03682536."

Journal • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • SF3B1

Updated overall survival (OS) and long-term transfusion-independence (TI) from the phase 3 COMMANDS trial in erythropoiesis-stimulating agent (ESA)–naive patients (pts) with lower-risk myelodysplastic syndromes (LR-MDS). (ASCO 2026) - P3 | "Funded by Bristol Myers Squibb Clinical Trial Registration Number: NCT03682536 Background: In the phase 3 COMMANDS trial (NCT03682536), luspatercept (LUSPA) significantly improved RBC-TI ≥12 wks with concurrent mean hemoglobin (Hb) increase ≥1.5 g/dL during wks 1-24 (primary endpoint) vs epoetin alfa (EA) in pts with ESA-naive transfusion-dependent (TD) LR-MDS. Long-term follow-up demonstrated improved OS trends and sustained responses with LUSPA vs EA, overall and in subgroups. No new safety concerns emerged, reinforcing superior clinical benefit as first-line treatment in LR-MDS."

Clinical • P3 data • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome

UPDATED OVERALL SURVIVAL AND LONG-TERM TRANSFUSION INDEPENDENCE IN ESA-NAIVE PATIENTS WITH LOWER-RISK MDS: RESULTS FROM THE PHASE 3 COMMANDS TRIAL (EHA 2026) - P3 | "Background In the phase 3 COMMANDS trial (NCT03682536), luspatercept (LUSPA) significantly improved red blood cell-transfusion independence (RBC-TI) ≥12 weeks with concurrent mean hemoglobin (Hb) increase ≥1.5 g/dL during Weeks 1–24 versus epoetin alfa (EA) in erythropoiesis-stimulating agent (ESA)-naive, transfusion-dependent (TD) patients (pts) with lower-risk myelodysplastic syndromes (LR-MDS). Reused with permission. This abstract was accepted and previously presented at the 2026 ASCO Annual Meeting."

Clinical • P3 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Assessment of Potential Drug Interactions in Patients With Chronic Kidney Disease Undergoing Hemodialysis. (PubMed, J Pharm Technol) - "The most frequent major interactions involved furosemide + losartan (n = 8) and acetylsalicylic acid + clopidogrel (n = 6)...The most frequent minor interactions involved epoetin alfa + acetylsalicylic acid (n = 14) and epoetin alfa + calcium carbonate (n = 10)... Potential drug interactions were highly prevalent among patients undergoing hemodialysis, with moderate-severity interactions predominating. Routine screening for potential drug interactions may support safer prescribing, optimize pharmacotherapy, and strengthen multidisciplinary medication management in this high-risk population."

Journal • Cardiovascular • Chronic Kidney Disease • Nephrology • Renal Disease

Effect of Daprodustat and Epoetin Alpha on Anemia in Patients Not Undergoing Dialysis (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: Services Hospital, Lahore

New trial • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Efficacy and Cardiovascular Safety of Pegmolesatide in Patients with Anemia of Chronic Kidney Disease: Post hoc Analysis of Two Phase 3 Randomized Trials. (PubMed, Kidney Dis (Basel)) - "The incidences of five-point MACE (DD-CKD: 3.7% vs. 6.5%, hazard ratio [HR] = 0.54 [95% CI: 0.21, 1.39]; NDD-CKD: 0.9% vs. 6.9%, HR = 0.14 [95% CI: 0.02, 1.28]), expanded CV events (DD-CKD: 9.8% vs. 11.3%, HR = 0.83 [95% CI: 0.43, 1.61]; NDD-CKD: 5.2% vs. 12.1%, HR = 0.49 [95% CI: 0.16, 1.45]) and three-point MACE (DD-CKD: 2.0% vs. 3.2%, HR = 0.60 [95% CI: 0.16, 2.23]; NDD-CKD: 0 vs. 1.7%, HR not estimable) were consistently lower in the pegmolesatide group across both patient populations. Pegmolesatide showed effectiveness in Hb management for both NDD-CKD and DD-CKD populations, with overall numerically favorable CV safety outcomes compared to epoetin alfa."

Journal • P3 data • Retrospective data • Anemia • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease