2024
Circulating Tumor DNA Dynamics Fail to Predict Efficacy of Poly(ADP-ribose) Polymerase/VEGFR Inhibition in Patients With Heavily Pretreated Advanced Solid Tumors
Hu Y, Narayan A, Xu Y, Wolfe J, Vu D, Trinh T, Kantak C, Ivy S, Eder J, Deng Y, LoRusso P, Kim J, Patel A. Circulating Tumor DNA Dynamics Fail to Predict Efficacy of Poly(ADP-ribose) Polymerase/VEGFR Inhibition in Patients With Heavily Pretreated Advanced Solid Tumors. JCO Precision Oncology 2024, 8: e2300289. PMID: 38412387, PMCID: PMC10914240, DOI: 10.1200/po.23.00289.Peer-Reviewed Original ResearchConceptsCell-free circulating tumor DNANon-small-cell lung cancerSmall-cell lung cancerTriple-negative breast cancerPancreatic ductal adenocarcinomaAdvanced solid tumorsVariant allele fractionRadiographic responseOverall survivalCombination therapySolid tumorsCtDNA levelsLung cancerPretreated advanced solid tumorsDays of combination therapyMetastatic pancreatic ductal adenocarcinomaResponse to anticancer therapyAssociated with disease progressionProgression-free survivalPlasma samplesLead-inPoly(ADP-riboseInferior OSTumor DNASurvival outcomes
2021
Safety 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
2020
A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
Somaiah N, Chawla SP, Block MS, Morris JC, Do K, Kim JW, Druta M, Sankhala KK, Hwu P, Jones RL, Gnjatic S, Kim-Schulze S, Tuballes K, Yishak M, Lu H, Yakovich A, Meulen J, Chen M, Kenney RT, Bohac C, Pollack SM. A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1. OncoImmunology 2020, 9: 1847846. PMID: 33312760, PMCID: PMC7714520, DOI: 10.1080/2162402x.2020.1847846.Peer-Reviewed Original ResearchConceptsNY-ESO-1Prime-boost vaccine regimenVaccine regimenImmune responseNY-ESO-1 immune responsesNY-ESO-1 antibodyNY-ESO-1 proteinToll-like receptor agonistsInjection site painOral metronomic cyclophosphamidePhase 1b studyRecombinant protein boostCommon adverse eventsDisease control ratePrime-boost vaccineT cell responsesDose-escalation designSoft tissue sarcomasLentiviral vectorsMetronomic cyclophosphamideAdverse eventsMetastatic diseaseOverall survivalProgressive diseaseStudy entry
2018
CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer
Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, Ott PA, Peltola K, Jaeger D, Evans J, de Braud F, Chau I, Harbison CT, Dorange C, Tschaika M, Le DT. CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer. Journal Of Clinical Oncology 2018, 36: 2836-2844. PMID: 30110194, PMCID: PMC6161834, DOI: 10.1200/jco.2017.76.6212.Peer-Reviewed Original ResearchConceptsObjective response rateGastroesophageal junction cancerEsophagogastric cancerJunction cancerOverall survivalTreatment-related grade 3/4 adverse eventsInvestigator-assessed objective response rateResponse rateGrade 3/4 adverse eventsProgression-free survival ratesEfficacy of nivolumabLong-term OSMeaningful antitumor activityMetastatic esophagogastric cancerMore prior therapiesNivolumab Plus IpilimumabSafety of nivolumabManageable safety profilePrimary end pointSecond-line chemotherapySuperior overall survivalPhase III studyAssociation of tumorPrior therapyData cutoffAtezolizumab (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
Safety and activity of nivolumab monotherapy in advanced and metastatic (A/M) gastric or gastroesophageal junction cancer (GC/GEC): Results from the CheckMate-032 study.
Le D, Bendell J, Calvo E, Kim J, Ascierto P, Sharma P, Ott P, Bono P, Jaeger D, Evans T, De Braud F, Chau I, Christensen O, Harbison C, Lin C, Janjigian Y. Safety and activity of nivolumab monotherapy in advanced and metastatic (A/M) gastric or gastroesophageal junction cancer (GC/GEC): Results from the CheckMate-032 study. Journal Of Clinical Oncology 2016, 34: 6-6. DOI: 10.1200/jco.2016.34.4_suppl.6.Peer-Reviewed Original ResearchObjective response rateNivolumab monotherapyOverall survivalPD-L1Negative tumorsPhase I/IIMedian overall survivalSingle-agent nivolumabTreatment-related deathsPD-L1 statusProgression-free survivalGastroesophageal junction cancerCell lung cancerFavorable safety profileRenal cell carcinomaAlkaline phosphatase levelsIgG4 monoclonal antibodyPrior regimensStable diseaseIntolerable toxicityMetastatic gastricPrimary endpointJunction cancerMedian durationObjective responseProspective Study Evaluating Na18F PET/CT in Predicting Clinical Outcomes and Survival in Advanced Prostate Cancer
Apolo AB, Lindenberg L, Shih JH, Mena E, Kim JW, Park JC, Alikhani A, McKinney YY, Weaver J, Turkbey B, Parnes HL, Wood LV, Madan RA, Gulley JL, Dahut WL, Kurdziel KA, Choyke PL. Prospective Study Evaluating Na18F PET/CT in Predicting Clinical Outcomes and Survival in Advanced Prostate Cancer. Journal Of Nuclear Medicine 2016, 57: 886-892. PMID: 26795292, PMCID: PMC6599519, DOI: 10.2967/jnumed.115.166512.Peer-Reviewed Original ResearchConceptsPET/CTAdvanced prostate cancerOverall survivalClinical impressionBone metastasesNumber of lesionsClinical outcomesProstate cancerMalignant lesionsMethylene diphosphonate bone scanProstate-specific antigen (PSA) changesPercentage changeMore bone metastasesDiphosphonate bone scanHigh-risk patientsProspective pilot studyPredicting Clinical OutcomesProstate cancer patientsMaximal percentage changeBone scanAntigen changesCancer patientsPositive lesionsBone diseaseMore lesions
2013
Safety profile of recombinant poxviral TRICOM vaccines.
Kim J, Marte J, Singh N, Heery C, Madan R, Pazdur M, McMahon S, Rauckhorst M, Schlom J, Kantoff P, Gulley J. Safety profile of recombinant poxviral TRICOM vaccines. Journal Of Clinical Oncology 2013, 31: e16036-e16036. DOI: 10.1200/jco.2013.31.15_suppl.e16036.Peer-Reviewed Original ResearchThrombotic thrombocytopenic purpuraAdverse eventsPoxviral vaccinesSafety profileMetastatic castration-resistant prostate cancerRandomized phase II trialCastration-resistant prostate cancerEmergent adverse eventsMedian overall survivalPhase II trialPhase III trialsTherapeutic cancer vaccinesResistant prostate cancerFavorable safety profileGranulocyte-macrophage colony-stimulating factorProstate-specific antigenRoute of administrationColony-stimulating factorII trialIII trialsOverall survivalVaccine injectionImmune adjuvantsThrombocytopenic purpuraCancer vaccines
2012
Therapeutic Cancer Vaccines in Prostate Cancer: The Quest for Intermediate Markers of Response
Kim JW, Bilusic M, Heery CJ, Madan RA. Therapeutic Cancer Vaccines in Prostate Cancer: The Quest for Intermediate Markers of Response. Cancers 2012, 4: 1229-1246. PMID: 24213505, PMCID: PMC3712729, DOI: 10.3390/cancers4041229.Peer-Reviewed Original ResearchClinical benefitIntermediate markersImmunotherapy clinical trialsTherapeutic cancer vaccinesPotential clinical roleTumor growth kineticsOverall survivalImmune infiltratesClinical outcomesCytokine responsesCancer vaccinesCellular immunityIntermediate biomarkersPeripheral bloodCancer immunotherapyClinical trialsParadoxical patternProstate cancerClinical roleProspective assessmentSystemic responseTherapy mechanismsBiomarkersImmunotherapySurvival