2021
Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation
Kim J, Cardin DB, Vaishampayan UN, Kato S, Grossman SR, Glazer P, Shyr Y, Ivy SP, LoRusso P. Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation. The Oncologist 2021, 26: e1104-e1109. PMID: 33742489, PMCID: PMC8265343, DOI: 10.1002/onco.13758.Peer-Reviewed Original ResearchConceptsMetastatic pancreatic adenocarcinomaHomologous recombination DNA repair deficiencyMetastatic pancreatic ductal adenocarcinomaPancreatic ductal adenocarcinomaOlaparib combinationStable diseaseBRCA mutationsAdverse eventsDuctal adenocarcinomaCommon treatment-related adverse eventsVascular endothelial growth factor receptor inhibitorEndothelial growth factor receptor inhibitorTreatment-related adverse eventsGrowth factor receptor inhibitorsPrior systemic chemotherapyMedian overall survivalObjective response rateGermline BRCA mutationsBest overall responseExpression of BRCA1/2Restaging scanCancer cell linesPrimary endpointStudy drugSystemic chemotherapySafety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I StudyAtezolizumab in Castration-Resistant Prostate Cancer
Petrylak DP, Loriot Y, Shaffer DR, Braiteh F, Powderly J, Harshman LC, Conkling P, Delord JP, Gordon M, Kim JW, Sarkar I, Yuen K, Kadel EE, Mariathasan S, O'Hear C, Narayanan S, Fassò M, Carroll S, Powles T. Safety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I StudyAtezolizumab in Castration-Resistant Prostate Cancer. Clinical Cancer Research 2021, 27: 3360-3369. PMID: 33568344, DOI: 10.1158/1078-0432.ccr-20-1981.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerPartial responseProstate cancerAtezolizumab monotherapyOverall survivalPrior linesImmune-related response criteriaTreatment-related adverse eventsDose-expansion studyPSA response rateMedian overall survivalBiomarker analysisEvaluable patientsRECIST 1.1Adverse eventsOS ratesClinical benefitSafety profileDisease progressionAtezolizumabClinical activityRadiographic assessmentImmune responseLimited efficacy
2019
First-in-Class, First-in-Human Study Evaluating LV305, a Dendritic-Cell Tropic Lentiviral Vector, in Sarcoma and Other Solid Tumors Expressing NY-ESO-1
Somaiah N, Block MS, Kim JW, Shapiro GI, T. K, Hwu P, Eder J, Jones RL, Lu H, Meulen J, Bohac C, Chen M, Hsu FJ, Gnjatic S, Pollack SM. First-in-Class, First-in-Human Study Evaluating LV305, a Dendritic-Cell Tropic Lentiviral Vector, in Sarcoma and Other Solid Tumors Expressing NY-ESO-1. Clinical Cancer Research 2019, 25: 5808-5817. PMID: 31227504, DOI: 10.1158/1078-0432.ccr-19-1025.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsAdverse eventsDendritic cellsSarcoma patientsImmune responseCommon treatment-related adverse eventsNY-ESO-1 immune responsesNY-ESO-1-expressing tumorsSolid tumorsLimited tumor burdenDisease control rateInjection site reactionsNY-ESO-1Potential clinical activityFavorable safety profileAntigen-specific responsesCancer-testis antigensAnti-NYDose cohortsPartial responseAdvanced cancerTumor burdenSafety profileSynovial sarcomaControl rateFirst-in-Human Phase I Trial of a Tumor-Targeted Cytokine (NHS-IL12) in Subjects with Metastatic Solid Tumors
Strauss J, Heery CR, Kim JW, Jochems C, Donahue RN, Montgomery AS, McMahon S, Lamping E, Marté J, Madan RA, Bilusic M, Silver MR, Bertotti E, Schlom J, Gulley JL. First-in-Human Phase I Trial of a Tumor-Targeted Cytokine (NHS-IL12) in Subjects with Metastatic Solid Tumors. Clinical Cancer Research 2019, 25: 99-109. PMID: 30131389, PMCID: PMC6320276, DOI: 10.1158/1078-0432.ccr-18-1512.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedCell Line, TumorDNA FragmentationDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunoglobulin GInfluenza, HumanInterleukin-12Killer Cells, NaturalLymphocytes, Tumor-InfiltratingMaleMaximum Tolerated DoseMiddle AgedNatural Killer T-CellsNeoplasmsNeoplasms, Second PrimaryReceptors, Antigen, T-CellRecombinant Fusion ProteinsTransaminasesConceptsTreatment-related adverse eventsAscending dose cohortsNHS-IL12Solid tumorsT-cell receptor sequencing analysisHuman phase I trialMultiple ascending dose cohortsSingle ascending dose (SAD) cohortsTumor-infiltrating lymphocyte densityPeripheral blood mononuclear cellsPeripheral immune cell subsetsDurable stable diseaseImmune checkpoint inhibitorsObjective tumor responsePhase II doseT-cell receptor diversityAdvanced solid tumorsFlu-like symptomsMetastatic solid tumorsPhase I trialNatural killer cellsImmune cell subsetsBlood mononuclear cellsWarrants further studyEnhanced antitumor activity
2018
Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study
Petrylak DP, Powles T, Bellmunt J, Braiteh F, Loriot Y, Morales-Barrera R, Burris HA, Kim JW, Ding B, Kaiser C, Fassò M, O’Hear C, Vogelzang NJ. Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. JAMA Oncology 2018, 4: 537-544. PMID: 29423515, PMCID: PMC5885219, DOI: 10.1001/jamaoncol.2017.5440.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarcinoma, Transitional CellCohort StudiesDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm MetastasisSurvival AnalysisTime FactorsUrinary Bladder NeoplasmsUrotheliumConceptsDeath ligand 1 (PD-L1) expressionMedian overall survivalMetastatic urothelial carcinomaLigand 1 expressionProgression-free survivalPhase 1 studyOverall survivalAdverse eventsClinical benefitUrothelial carcinomaImmune cellsEastern Cooperative Oncology Group performance status 0Long-term clinical profilesMedian progression-free survivalSerious related adverse eventsSolid Tumors version 1.1Treatment-related adverse eventsLong-term clinical outcomesTumor-infiltrating immune cellsPerformance status 0Treatment-related deathsUnacceptable toxic effectsMetastatic urothelial cancerObjective response rateThird-line therapy
2016
Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial
Sharma P, Callahan MK, Bono P, Kim J, Spiliopoulou P, Calvo E, Pillai RN, Ott PA, de Braud F, Morse M, Le DT, Jaeger D, Chan E, Harbison C, Lin CS, Tschaika M, Azrilevich A, Rosenberg JE. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. The Lancet Oncology 2016, 17: 1590-1598. PMID: 27733243, PMCID: PMC5648054, DOI: 10.1016/s1470-2045(16)30496-x.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaTreatment-related adverse eventsAdvanced urothelial carcinomaSerious adverse eventsPlatinum-based chemotherapyUrothelial carcinomaAdverse eventsNivolumab monotherapyObjective responseInvestigator-assessed objective responsePrevious platinum-based chemotherapyProtocol-defined reasonsSafety of nivolumabManageable safety profileOpen-label studyPD-L1 expressionDurable clinical responsesDose of treatmentBristol-Myers SquibbCheckMate 032Data cutoffElevated lipaseMonotherapy groupPrimary endpointStudy drug