2024
Phase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC‐1 study design
Groarke J, Crawford J, Collins S, Lubaczewski S, Breen D, Harrington M, Jacobs I, Qiu R, Revkin J, Rossulek M, Saxena A. Phase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC‐1 study design. Journal Of Cachexia Sarcopenia And Muscle 2024, 15: 1054-1061. PMID: 38500292, PMCID: PMC11154777, DOI: 10.1002/jcsm.13435.Peer-Reviewed Original ResearchPhysical activityPhysical functionPhase 2 studyCancer cachexiaGDF-15 concentrationsGDF-15Unintentional loss of weightLumbar skeletal muscle indexQuality of lifeSkeletal muscle indexBiomarker of cancer cachexiaNon-small-cell lungIncidence of adverse eventsResponse Evaluation CriteriaGrowth differentiation factor 15Safety laboratory testsOpen-label treatmentPlacebo-controlled studyCharacteristics of cachexiaCancer-related cachexiaMetabolic wasting syndromeHuman monoclonal antibodyCancer-relatedDifferentiation factor 15Phase 1 data
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