2017
Results from an Integrated Safety Analysis of Urelumab, an Agonist Anti-CD137 Monoclonal Antibody
Segal NH, Logan TF, Hodi FS, McDermott D, Melero I, Hamid O, Schmidt H, Robert C, Chiarion-Sileni V, Ascierto PA, Maio M, Urba WJ, Gangadhar TC, Suryawanshi S, Neely J, Jure-Kunkel M, Krishnan S, Kohrt H, Sznol M, Levy R. Results from an Integrated Safety Analysis of Urelumab, an Agonist Anti-CD137 Monoclonal Antibody. Clinical Cancer Research 2017, 23: 1929-1936. PMID: 27756788, DOI: 10.1158/1078-0432.ccr-16-1272.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsAdverse eventsPharmacodynamic activityCommon treatment-related adverse eventsLiver function test abnormalitiesImmuno-oncology agentsSerious adverse eventsAdvanced solid tumorsHepatic adverse eventsClin Cancer ResSignificant transaminitisMonotherapy studiesAdvanced cancerTest abnormalitiesIFN-inducible genesStandard treatmentClinical evaluationUrelumabSafety dataAgonist antibodySolid tumorsCancer ResDoseDosesWeeks
2016
Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma
Weber JS, Hodi FS, Wolchok JD, Topalian SL, Schadendorf D, Larkin J, Sznol M, Long GV, Li H, Waxman IM, Jiang J, Robert C. Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma. Journal Of Clinical Oncology 2016, 35: jco.2015.66.138. PMID: 28068177, DOI: 10.1200/jco.2015.66.1389.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsSelect adverse eventsObjective response rateImmune-modulating agentsTreatment-related select adverse eventsAdverse eventsNivolumab monotherapyAdvanced melanomaSafety profileGrade 3Grade treatment-related adverse eventsProgression-free survival benefitHigher objective response rateRenal adverse eventsPhase III trialsDrug-related deathsNumber of dosesIII trialsSurvival benefitMedian timePooled analysisSafety guidelinesRetrospective analysisSafety dataPatients