2019
Tumor mutational load predicts survival after immunotherapy across multiple cancer types
Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, Kaley TJ, Kendall SM, Motzer RJ, Hakimi AA, Voss MH, Russo P, Rosenberg J, Iyer G, Bochner BH, Bajorin DF, Al-Ahmadie HA, Chaft JE, Rudin CM, Riely GJ, Baxi S, Ho AL, Wong RJ, Pfister DG, Wolchok JD, Barker CA, Gutin PH, Brennan CW, Tabar V, Mellinghoff IK, DeAngelis LM, Ariyan CE, Lee N, Tap WD, Gounder MM, D’Angelo S, Saltz L, Stadler ZK, Scher HI, Baselga J, Razavi P, Klebanoff CA, Yaeger R, Segal NH, Ku GY, DeMatteo RP, Ladanyi M, Rizvi NA, Berger MF, Riaz N, Solit DB, Chan TA, Morris LGT. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nature Genetics 2019, 51: 202-206. PMID: 30643254, PMCID: PMC6365097, DOI: 10.1038/s41588-018-0312-8.Peer-Reviewed Original ResearchConceptsTumor mutational burdenHigh tumor mutational burdenImproved survivalCancer typesImmune checkpoint inhibitor treatmentAdvanced cancer patientsBetter overall survivalCheckpoint inhibitor treatmentMultiple cancer typesClinical responseOverall survivalCancer patientsPredictive biomarkersCancer histologyMetastatic cancerMutational burdenPatientsInhibitor treatmentNext-generation sequencingSurvivalICIMutational loadUniversal definitionAssociationImmunotherapy
2017
OS10.3 Randomized Phase 3 Study Evaluating the Efficacy and Safety of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: CheckMate 143
Reardon D, Omuro A, Brandes A, Rieger J, Wick A, Sepulveda J, Phuphanich S, de Souza P, Ahluwalia M, Lim M, Vlahovic G, Sampson J. OS10.3 Randomized Phase 3 Study Evaluating the Efficacy and Safety of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: CheckMate 143. Neuro-Oncology 2017, 19: iii21-iii21. PMCID: PMC5463583, DOI: 10.1093/neuonc/nox036.071.Peer-Reviewed Original ResearchObjective response rateTreatment-related AEsProgression-free survivalOverall survivalRecurrent glioblastomaSerious AEsMeasurable diseaseOS ratesInvestigator-assessed progression-free survivalCommon treatment-related AEsHuman IgG4 monoclonal antibodyOnly serious AESafety of nivolumabMedian overall survivalNeuro-Oncology criteriaSecond-line settingDeath-1 receptorSingle-agent therapyAvailable treatment optionsMalignant neoplasm progressionIgG4 monoclonal antibodyMultiple cancer typesCheckMate 143Evaluable ptsImproved OSOS07.3 Nivolumab in Combination With Radiotherapy With or Without Temozolomide in Patients With Newly Diagnosed Glioblastoma: Updated Results From CheckMate 143
Omuro A, Vlahovic G, Baehring J, Butowski N, Reardon D, Cloughesy T, Sahebjam S, Lim M, Zwirtes R, Sampson J. OS07.3 Nivolumab in Combination With Radiotherapy With or Without Temozolomide in Patients With Newly Diagnosed Glioblastoma: Updated Results From CheckMate 143. Neuro-Oncology 2017, 19: iii13-iii13. PMCID: PMC5463686, DOI: 10.1093/neuonc/nox036.044.Peer-Reviewed Original ResearchTreatment-related AEsAdverse eventsCheckMate 143Standard radiotherapyDisease progressionFirst prospective clinical trialHerpes simplex virus encephalitisTreatment-related adverse eventsTolerability of nivolumabTreatment-related deathsImmune checkpoint inhibitorsSimplex virus encephalitisDeath-1 receptorNew safety signalsPhase 2/3 studyProspective clinical trialsImmune cell infiltrationNovel therapeutic optionsMonoclonal antibody inhibitorMultiple cancer typesConcurrent temozolomideUnmethylated MGMTAdjuvant temozolomideCheckpoint inhibitorsRadiographic progression
2016
ATIM-16. NIVOLUMAB COMBINED WITH RADIOTHERAPY WITH OR WITHOUT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA: RESULTS FROM PHASE 1 SAFETY COHORTS IN CHECKMATE 143
Omuro A, Vlahovic G, Baehring J, Butowski N, Reardon D, Cloughesy T, Sahebjam S, Lim M, Strauss L, Latek R, Zwirtes R, Paliwal P, Harbison C, Sampson J. ATIM-16. NIVOLUMAB COMBINED WITH RADIOTHERAPY WITH OR WITHOUT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA: RESULTS FROM PHASE 1 SAFETY COHORTS IN CHECKMATE 143. Neuro-Oncology 2016, 18: vi21-vi21. DOI: 10.1093/neuonc/now212.081.Peer-Reviewed Original ResearchAdverse eventsCheckMate 143Frequent treatment-related adverse eventsTreatment-related serious adverse eventsFirst prospective clinical trialProgression/unacceptable toxicityTreatment-related adverse eventsCombination of nivolumabTolerability of nivolumabSerious adverse eventsDeath-1 receptorProspective clinical trialsNew safety concernsMonoclonal antibody inhibitorMultiple cancer typesMeasurable diseaseNivolumab CombinedSafety cohortToxic deathsTumor flareRadiographic progressionTreatment discontinuationMost patientsUnacceptable toxicityPoor prognosis