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 rate
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 response
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