2024
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
Porta M, Garcia-Manero G, Santini V, Zeidan A, Komrokji R, Shortt J, Valcárcel D, Jonasova A, Dimicoli-Salazar S, Tiong I, Lin C, Li J, Zhang J, Pilot R, Kreitz S, Pozharskaya V, Keeperman K, Rose S, Prebet T, Lai Y, Degulys A, Paolini S, Cluzeau T, Fenaux P, Platzbecker U. 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. The Lancet Haematology 2024 PMID: 39038479, DOI: 10.1016/s2352-3026(24)00203-5.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesRed blood cell transfusion independenceTreatment-emergent adverse eventsMedian follow-upEpoetin alfa groupMyelodysplastic syndromeLuspatercept groupTransfusion-dependentSerum erythropoietin concentrationPrimary endpointEpoetin alfaTransfusion independenceOpen-labelAlfa groupAdverse eventsFollow-upRed blood cell transfusion burdenErythropoietin concentrationIntention-to-treat populationControlled trialsCommon grade 3Epoetin alfa recipientsMean haemoglobin increasePrimary analysisProportion of patientsEFFICACY AND SAFETY OF LUSPATERCEPT VERSUS EPOETIN ALFA IN ERYTHROPOIESIS-STIMULATING AGENT (ESA)-NAIVE PATIENTS WITH TRANSFUSION-DEPENDENT LOWER-RISK MYELODYSPLASTIC SYNDROMES (LR-MDS): FULL ANALYSIS OF THE COMMANDS TRIAL
Garcia-Manero G, Platzbecker U, Santini V, Zeidan A, Fenaux P, Komrokji R, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong I, Lin C, Li J, Zhang J, Giuseppi A, Kreitz S, Pozharskaya V, Keeperman K, Rose S, Prebet T, Degulys A, Paolini S, Cluzeau T, Della Porta M. EFFICACY AND SAFETY OF LUSPATERCEPT VERSUS EPOETIN ALFA IN ERYTHROPOIESIS-STIMULATING AGENT (ESA)-NAIVE PATIENTS WITH TRANSFUSION-DEPENDENT LOWER-RISK MYELODYSPLASTIC SYNDROMES (LR-MDS): FULL ANALYSIS OF THE COMMANDS TRIAL. Leukemia Research Reports 2024, 21: 100447. DOI: 10.1016/j.lrr.2024.100447.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesTreatment-emergent adverse eventsEA-treated patientsRBC-TIPrimary endpointHI-ERed blood cell transfusion independenceHematological improvement-erythroidTransfusion independenceErythroid responseMyelodysplastic syndromeSecondary endpointsAdverse eventsFull analysisLuspaterceptAssessed efficacySafety resultsEpoetin alfaTreatment durationPatientsEndpointEfficacyDurationPost-treatmentAML
2022
Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial
Watts J, Baer M, Yang J, Prebet T, Lee S, Schiller G, Dinner S, Pigneux A, Montesinos P, Wang E, Seiter K, Wei A, De Botton S, Arnan M, Donnellan W, Schwarer A, Récher C, Jonas B, Ferrell P, Marzac C, Kelly P, Sweeney J, Forsyth S, Guichard S, Brevard J, Henrick P, Mohamed H, Cortes J. Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial. The Lancet Haematology 2022, 10: e46-e58. PMID: 36370742, DOI: 10.1016/s2352-3026(22)00292-7.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaInhibitor of mutant isocitrate dehydrogenase 1Recommended phase 2 doseIDH1-mutated acute myeloid leukemiaPhase 2 doseDose-limiting toxicityCombination therapy groupMyeloid leukemiaCombination therapyMyelodysplastic syndromeClinical activityFebrile neutropeniaMonotherapy groupSmall-molecule inhibitor of mutant isocitrate dehydrogenase 1Eastern Cooperative Oncology Group performance status 0Treatment-emergent adverse eventsHigh-risk myelodysplastic syndromeRefractory acute myeloid leukemiaOpen-label clinical trialTherapy groupDose-escalation cohortsPerformance status 0Phase 1/2 studyTreatment-naive patientsPhase 1/2 trial