2023
Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab
Topalian S, Sznol M, McDermott D, Kluger H, Carvajal R, Sharfman W, Brahmer J, Lawrence D, Atkins M, Powderly J, Leming P, Lipson E, Puzanov I, Smith D, Taube J, Wigginton J, Kollia G, Gupta A, Pardoll D, Sosman J, Hodi F. Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab. Journal Of Clinical Oncology 2023, 41: 943-954. PMID: 36750016, DOI: 10.1200/jco.22.02272.Peer-Reviewed Original ResearchLong-term safetyOverall survivalToxicity ratesTumor regressionResponse durationOngoing randomized clinical trialsDurable tumor remissionNivolumab-treated patientsMedian overall survivalMedian response durationPD-1 blockadeObjective tumor regressionMaintenance of responseCell death 1Randomized clinical trialsSimilar patient populationsActivated T cellsDrug discontinuationIntravenous nivolumabNivolumab therapyNivolumab treatmentTreatment discontinuationObjective responseAdvanced melanomaDeath-1
2014
Induction of Antigen-Specific Immunity with a Vaccine Targeting NY-ESO-1 to the Dendritic Cell Receptor DEC-205
Dhodapkar MV, Sznol M, Zhao B, Wang D, Carvajal RD, Keohan ML, Chuang E, Sanborn RE, Lutzky J, Powderly J, Kluger H, Tejwani S, Green J, Ramakrishna V, Crocker A, Vitale L, Yellin M, Davis T, Keler T. Induction of Antigen-Specific Immunity with a Vaccine Targeting NY-ESO-1 to the Dendritic Cell Receptor DEC-205. Science Translational Medicine 2014, 6: 232ra51. PMID: 24739759, PMCID: PMC6151129, DOI: 10.1126/scitranslmed.3008068.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntigens, CDAntigens, NeoplasmCancer VaccinesCytokinesDendritic CellsDose-Response Relationship, ImmunologicEpitopesFemaleHumansImmunity, CellularImmunity, HumoralImmunoglobulin GInterferon-gammaLectins, C-TypeLymphocyte SubsetsMaleMembrane ProteinsMiddle AgedMinor Histocompatibility AntigensReceptors, Cell SurfaceT-LymphocytesVaccinationConceptsNY-ESO-1Immune checkpoint inhibitorsDendritic cellsToll-like receptorsTumor regressionNY-ESO-1-expressing tumorsTumor antigen NY-ESO-1Presence of DCsRobust antigen-specific immune responsesAntigen-specific immune responsesAntigen NY-ESO-1Combination immunotherapy strategiesStabilization of diseaseGrade 3 toxicityObjective tumor regressionImmune checkpoint blockadeT cell immunityAntigen-specific immunityPhase 1 trialTumor-associated antigensReceptor-specific monoclonal antibodyCheckpoint inhibitorsAdvanced malignanciesCheckpoint blockadeMedian durationSurvival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab
Topalian SL, Sznol M, McDermott DF, Kluger HM, Carvajal RD, Sharfman WH, Brahmer JR, Lawrence DP, Atkins MB, Powderly JD, Leming PD, Lipson EJ, Puzanov I, Smith DC, Taube JM, Wigginton JM, Kollia GD, Gupta A, Pardoll DM, Sosman JA, Hodi FS. Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab. Journal Of Clinical Oncology 2014, 32: 1020-1030. PMID: 24590637, PMCID: PMC4811023, DOI: 10.1200/jco.2013.53.0105.Peer-Reviewed Original ResearchConceptsLong-term safetyOverall survivalToxicity ratesTumor regressionResponse durationOngoing randomized clinical trialsDurable tumor remissionNivolumab-treated patientsMedian overall survivalMedian response durationPD-1 blockadeObjective tumor regressionMaintenance of responseCell death 1Randomized clinical trialsSimilar patient populationsActivated T cellsDrug discontinuationIntravenous nivolumabNivolumab therapyNivolumab treatmentTreatment discontinuationObjective responseAdvanced melanomaDeath-1
2013
Activity of cabozantinib in metastatic uveal melanoma: Updated results from a phase II randomized discontinuation trial (RDT).
Daud A, Kluger H, Edelman G, Gordon M, Schimmoller F, Weitzman A, Samuel T, Moussa A, Flaherty K, Shapiro G. Activity of cabozantinib in metastatic uveal melanoma: Updated results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2013, 31: 9094-9094. DOI: 10.1200/jco.2013.31.15_suppl.9094.Peer-Reviewed Original ResearchMedian overall survivalOverall survivalMetastatic uveal melanomaUveal melanomaMelanoma cohortRandomized phase 2 studyGNA11 mutationsActivity of cabozantinibGrade 3/4 AEsSafety of cabozantinibSubstantial tumor burdenObjective tumor regressionPhase 2 studyStudy days 1Long-term followupTumor mutation statusGNAQ/GNA11 mutationsUpregulation of METEligible ptsAbdominal painMeasurable diseaseMedian PFSPrior regimensTerm FollowupMedian age
2012
Activity of cabozantinib (XL184) in metastatic NSCLC: Results from a phase II randomized discontinuation trial (RDT).
Hellerstedt B, Edelman G, Vogelzang N, Kluger H, Yasenchak C, Shen X, Ramies D, Gordon M, Lara P. Activity of cabozantinib (XL184) in metastatic NSCLC: Results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2012, 30: 7514-7514. DOI: 10.1200/jco.2012.30.15_suppl.7514.Peer-Reviewed Original ResearchObjective tumor regressionMedian PFSTumor regressionWk 12Median age 67 yearsOverall disease control ratePost-baseline tumour assessmentPrior exposureActivity of cabozantinibDisease control rateGrade 3/4 AEsGrade 5 AEsMedian prior linesAge 67 yearsStudy days 1Dysregulation of METMET upregulationNSCLC ptsPrior EGFRPrior erlotinibRECIST responseTherapy 50Eligible patientsMeasurable diseaseMetastatic NSCLCActivity of cabozantinib (XL184) in metastatic melanoma: Results from a phase II randomized discontinuation trial (RDT).
Gordon M, Kluger H, Shapiro G, Kurzrock R, Edelman G, Samuel T, Moussa A, Ramies D, Laird A, Schimmoller F, Shen X, Daud A. Activity of cabozantinib (XL184) in metastatic melanoma: Results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2012, 30: 8531-8531. DOI: 10.1200/jco.2012.30.15_suppl.8531.Peer-Reviewed Original ResearchProgression-free survivalMedian progression-free survivalObjective tumor regressionTumor regressionPost-baseline tumour assessmentMedian age 66 yearsActivity of cabozantinibGrade 3/4 AEsGrade 5 AEsMedian prior linesOpen-label leadAge 66 yearsStudy days 1BRAF mutation statusMeasurable diseaseDiverticular perforationEligible patientsPrimary endpointFree survivalPain reliefPrior linesMonth 6VEGFR-TKIDiscontinuation trialSafety profile