2023
Phase 2 study to assess the efficacy, safety, and tolerability of the GDF-15 inhibitor ponsegromab in patients with cancer cachexia.
Crawford J, Lubaczewski S, Tarachandani A, Harrington M, Weng Y, Qiu R, Collins S, Rossulek M, Revkin J. Phase 2 study to assess the efficacy, safety, and tolerability of the GDF-15 inhibitor ponsegromab in patients with cancer cachexia. Journal Of Clinical Oncology 2023, 41: tps12147-tps12147. DOI: 10.1200/jco.2023.41.16_suppl.tps12147.Peer-Reviewed Original ResearchGDF-15 concentrationsCancer cachexiaPhysical activityBody weightSelective humanized monoclonal antibodyNon-small cell lungGrowth differentiation factor 15Double-blind periodMultifactorial metabolic syndromeSafety laboratory testsUnintended weight lossWeek 12 visitPlacebo-controlled studyOpen-label treatmentPhase 2 studyDifferentiation factor 15Humanized monoclonal antibodyE max modelSkeletal muscle massQuality of lifePrimary endpointSecondary endpointsWeek 72Adverse eventsGDF-15
2017
Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab
Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. New England Journal Of Medicine 2017, 376: 1517-1526. PMID: 28304227, DOI: 10.1056/nejmoa1614062.Peer-Reviewed Original ResearchConceptsLDL cholesterol levelsProprotein convertase subtilisin kexin type 9Antidrug antibodiesCholesterol levelsLipoprotein cholesterolLow-density lipoprotein cholesterolSubtilisin kexin type 9Antidrug antibody formationLipid-lowering trialsCommon adverse eventsMajor cardiovascular eventsDensity lipoprotein cholesterolInjection site reactionsTime of enrollmentHumanized monoclonal antibodyCardiovascular eventsStatin therapyAdverse eventsTotal cholesterolMultinational trialTreatment periodBococizumabApolipoprotein BPatientsType 9