2024
A first-in-human, phase 1, dose escalation study of SGR-2921 as monotherapy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome.
Weiss D, Dinardo C, Strickland S, Skikne B, Zeidan A, Traer E, Carraway H, Carraway H, Frankel S, Wang J, Pirie-Shepherd S, Piccotti J, Wright D, Akinsanya K. A first-in-human, phase 1, dose escalation study of SGR-2921 as monotherapy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome. Journal Of Clinical Oncology 2024, 42: tps6590-tps6590. DOI: 10.1200/jco.2024.42.16_suppl.tps6590.Peer-Reviewed Original ResearchEastern Cooperative Oncology GroupCell line-derived xenograftsDose-escalation studyMaximum tolerated dosePatient-derived xenograftsHigh riskEscalation studyTreatment armsEffects of CYP3A4 inhibitionRecommended phase 2 doseRelapsed/refractory acute myeloid leukemiaPhase 2 doseAccelerated titration designMinichromosome maintenance protein 2Preliminary antitumor activityCooperative Oncology GroupFirst-in-humanAcute myeloid leukemiaGrade 2 eventsTreated patient populationTolerated dose levelsAML cell linesAnti-tumor activityInhibition of Cdc7Cancer cell death
2023
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
Oliva E, Platzbecker U, Della Porta M, Garcia-Manero G, Santini V, Fenaux P, Shortt J, Komrokji R, Pelligra C, Guo S, Lord-Bessen J, Xiao H, Yucel A, Miteva D, Rose S, Kreitz S, Sekeres M, Zeidan A. 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. Blood 2023, 142: 4596. DOI: 10.1182/blood-2023-174660.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesEORTC QLQ-C30Patient-reported outcomesErythropoietin-stimulating agentsEpoetin alfaQLQ-C30FACT-AnSustained improvementTreatment armsESA-naïveTransfusion-DependentTreatment tolerabilityStratified Cox proportional hazards regression modelDay 1Cox proportional hazards regression modelCancer Therapy-Anemia (FACT-An) questionnaireLife Questionnaire Core 30Proportional hazards regression modelsMajority of patientsTreatment side effectsPost-baseline visitTransfusion-dependent patientsErythropoiesis stimulating agentsHazards regression modelsPhase 3A First-in-Human, Phase 1, Dose Escalation Study of Sgr-2921 As Monotherapy in Subjects with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
DiNardo C, Strickland S, Skikne B, Zeidan A, Traer E, Carraway H, Frankel S, Weiss D, Wang J, Pirie-Shepherd S, Piccotti J, Wright D, Akinsanya K. A First-in-Human, Phase 1, Dose Escalation Study of Sgr-2921 As Monotherapy in Subjects with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. Blood 2023, 142: 1548. DOI: 10.1182/blood-2023-186036.Peer-Reviewed Original ResearchR AMLAcute myeloid leukemiaRefractory acute myeloid leukemiaCell line-derived xenograftsDose-escalation studyMyelodysplastic syndromeCentral nervous systemDose levelsEscalation studyFirst doseTreatment armsMyeloid leukemiaEastern Cooperative Oncology Group performance statusRelapsed/Refractory Acute Myeloid LeukemiaPatient-derived xenograft AML modelHigh-risk myelodysplastic syndromeHigh unmet medical needAnimal models representativeMultiple prior linesPhase 2 doseSingle-patient cohortsTreatment arm ATreatment arm B.Antitumor activitySingle-dose pharmacokinetics
2020
MDS-179: Clinical Benefit of Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS) and High Transfusion Burden (HTB) in the Phase 3 MEDALIST Study
Zeidan A, Garcia-Manero G, DeZern A, Fenaux P, Greenberg P, Savona M, Jurcic J, Verma A, Mufti G, Buckstein R, Santini V, Laadem A, Zhang J, Rampersad A, Sinsimer D, Louis C, Linde P, Platzbecker U, Sekeres M. MDS-179: Clinical Benefit of Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS) and High Transfusion Burden (HTB) in the Phase 3 MEDALIST Study. Clinical Lymphoma Myeloma & Leukemia 2020, 20: s318-s319. DOI: 10.1016/s2152-2650(20)30973-3.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesTreatment-emergent adverse eventsHigh transfusion burdenRBC transfusion independenceRing sideroblastsTransfusion burdenTransfusion eventsClinical benefitWeek 1Serious treatment-emergent adverse eventsSignificant clinical unmet needPlacebo-treated patientsRBC transfusion burdenRegular RBC transfusionsClinical unmet needErythropoiesis-stimulating agentsOverall study populationEligible patientsPlacebo patientsAdverse eventsMedian durationPlacebo armRBC transfusionMedian timeTreatment arms