2022
Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter
Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro-Oncology 2022, 24: 1935-1949. PMID: 35511454, PMCID: PMC9629431, DOI: 10.1093/neuonc/noac116.Peer-Reviewed Original ResearchConceptsProgression-free survivalOverall survivalMGMT promoterBaseline corticosteroidsTreatment-related adverse event ratesImmune checkpoint inhibitor nivolumabNew safety signalsPhase III trialsAdverse event ratesCheckpoint inhibitor nivolumabCare radiotherapyInhibitor nivolumabPrimary endpointIII trialsSame regimenExperience recurrenceNivolumabSafety signalsPlaceboPatientsRadiotherapyTemozolomideEvent ratesMonthsPhase III
2021
CTIM-25. A RANDOMIZED PHASE 3 STUDY OF NIVOLUMAB OR PLACEBO COMBINED WITH RADIOTHERAPY PLUS TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA WITH METHYLATED MGMT PROMOTER: CHECKMATE 548
Weller M, Lim M, Idbaih A, Steinbach J, Finocchiaro G, Raval R, Ashby L, Ansstas G, Baehring J, Taylor J, Honnorat J, Petrecca K, de Vos F, Wick A, Sumrall A, Roberts M, Slepetis R, Warad D, Lee M, Reardon D, Omuro A. CTIM-25. A RANDOMIZED PHASE 3 STUDY OF NIVOLUMAB OR PLACEBO COMBINED WITH RADIOTHERAPY PLUS TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA WITH METHYLATED MGMT PROMOTER: CHECKMATE 548. Neuro-Oncology 2021, 23: vi55-vi56. PMCID: PMC8598415, DOI: 10.1093/neuonc/noab196.217.Peer-Reviewed Original ResearchProgression-free survivalMedian overall survivalPhase 3 studyOverall survivalMGMT promoterBaseline corticosteroidsMedian progression-free survivalTreatment-related adverse eventsRandomized phase 3 studyTumor PD-L1 expressionBlinded independent central reviewDual primary endpointsRole of immunotherapyNew safety signalsPD-L1 expressionPositive prognostic factorIndependent central reviewPredictors of benefitCare radiotherapyTreatment landscapeAdverse eventsPrognostic factorsCentral reviewNivolumabNovel therapies
2019
ATIM-47. NIVOLUMAB VS BEVACIZUMAB IN PATIENTS WITH RECURRENT GLIOBLASTOMA: EXPLORATORY ANALYSIS OF MGMT METHYLATION STATUS AND BASELINE CORTICOSTEROID USE
Weller M, Reardon D, Brandes A, Sampson J, Mulholland P, Wick A, Baehring J, Ahluwalia M, Roth P, Bähr O, Phuphanich S, Sepulveda J, de Souza P, Sahebjam S, Potter V, Tatsuoka K, Taitt C, Zwirtes R, Omuro A, Lim M. ATIM-47. NIVOLUMAB VS BEVACIZUMAB IN PATIENTS WITH RECURRENT GLIOBLASTOMA: EXPLORATORY ANALYSIS OF MGMT METHYLATION STATUS AND BASELINE CORTICOSTEROID USE. Neuro-Oncology 2019, 21: vi12-vi12. PMCID: PMC6847600, DOI: 10.1093/neuonc/noz175.045.Peer-Reviewed Original ResearchMedian overall survivalBaseline corticosteroid useCorticosteroid useBaseline corticosteroidsMGMT methylation statusRecurrent glioblastomaUnmethylated tumorsMultivariable Cox proportional hazards model analysisCox proportional hazards model analysisLonger median overall survivalProportional hazards model analysisBevacizumab-treated patientsLimited survival benefitNivolumab-treated patientsSubgroup of patientsExploratory subgroup analysisHazards model analysisMethyltransferase promoter methylation statusDNA methyltransferase promoter methylation statusMethylation statusMGMT promoter statusTemozolomide chemoradiotherapyFirst recurrencePrimary endpointOverall survival