2023
Safety and Activity of Immune Checkpoint Inhibitors in People Living With HIV and Cancer: A Real-World Report From the Cancer Therapy Using Checkpoint Inhibitors in People Living With HIV-International (CATCH-IT) Consortium
El Zarif T, Nassar A, Adib E, Fitzgerald B, Huang J, Mouhieddine T, Rubinstein P, Nonato T, McKay R, Li M, Mittra A, Owen D, Baiocchi R, Lorentsen M, Dittus C, Dizman N, Falohun A, Abdel-Wahab N, Diab A, Bankapur A, Reed A, Kim C, Arora A, Shah N, El-Am E, Kozaily E, Abdallah W, Al-Hader A, Abu Ghazal B, Saeed A, Drolen C, Lechner M, Drakaki A, Baena J, Nebhan C, Haykal T, Morse M, Cortellini A, Pinato D, Dalla Pria A, Hall E, Bakalov V, Bahary N, Rajkumar A, Mangla A, Shah V, Singh P, Aboubakar Nana F, Lopetegui-Lia N, Dima D, Dobbs R, Funchain P, Saleem R, Woodford R, Long G, Menzies A, Genova C, Barletta G, Puri S, Florou V, Idossa D, Saponara M, Queirolo P, Lamberti G, Addeo A, Bersanelli M, Freeman D, Xie W, Reid E, Chiao E, Sharon E, Johnson D, Ramaswami R, Bower M, Emu B, Marron T, Choueiri T, Baden L, Lurain K, Sonpavde G, Naqash A. Safety and Activity of Immune Checkpoint Inhibitors in People Living With HIV and Cancer: A Real-World Report From the Cancer Therapy Using Checkpoint Inhibitors in People Living With HIV-International (CATCH-IT) Consortium. Journal Of Clinical Oncology 2023, 41: 3712-3723. PMID: 37192435, PMCID: PMC10351941, DOI: 10.1200/jco.22.02459.Peer-Reviewed Original ResearchConceptsImmune-related adverse eventsProgression-free survivalObjective response rateOverall survivalMetastatic NSCLCCheckpoint inhibitorsGrade immune-related adverse eventsImmune checkpoint inhibitor trialsNeck squamous cell carcinomaActivity of ICICheckpoint inhibitor trialsCohort of PWHImmune checkpoint inhibitorsHIV viral loadKaplan-Meier methodSquamous cell carcinomaUse of ICIMean survival timeMost common cancersL1 monotherapyRECIST 1.1Adverse eventsInhibitor trialsMedian ageAdvanced cancer
2019
Assessment of the Safety of Pembrolizumab in Patients With HIV and Advanced Cancer—A Phase 1 Study
Uldrick TS, Gonçalves PH, Abdul-Hay M, Claeys AJ, Emu B, Ernstoff MS, Fling SP, Fong L, Kaiser JC, Lacroix AM, Lee SY, Lundgren LM, Lurain K, Parsons CH, Peeramsetti S, Ramaswami R, Sharon E, Sznol M, Wang C, Yarchoan R, Cheever MA. Assessment of the Safety of Pembrolizumab in Patients With HIV and Advanced Cancer—A Phase 1 Study. JAMA Oncology 2019, 5: 1332-1339. PMID: 31154457, PMCID: PMC6547135, DOI: 10.1001/jamaoncol.2019.2244.Peer-Reviewed Original ResearchNon-Hodgkin lymphomaSafety of pembrolizumabB-cell lymphoproliferationCells/μLAntiretroviral therapyTumor responseKaposi's sarcomaStable diseaseCD4 countAdverse eventsAdvanced cancerMost treatment-emergent adverse eventsAdverse Events grade 2Anti-PD-1 therapyNCI Common Terminology CriteriaTreatment-emergent adverse eventsActive immunosuppressive therapyCommon Terminology CriteriaGood tumor responseT-cell countsAlanine aminotransferase levelsHIV viral loadPhase 1 studyImmune-related eventsCopies/mLPhase I study of pembrolizumab in people with HIV and cancer.
Uldrick T, Goncalves P, Abdul Hay M, Claeys A, Emu B, Ernstoff M, Fong L, Kaiser J, Kohrt H, Lacroix A, Lee S, Lundgren L, Lurain K, Parsons C, Peeramsetti S, Ramaswami R, Sharon E, Wang C, Yarchoan R, Cheever M. Phase I study of pembrolizumab in people with HIV and cancer. Journal Of Clinical Oncology 2019, 37: 2500-2500. DOI: 10.1200/jco.2019.37.15_suppl.2500.Peer-Reviewed Original ResearchAdverse eventsNon-Hodgkin lymphomaAntiretroviral therapyViral loadClinical benefitAnti-PD-1/PD-L1 therapyCD4 cells/μL.Elevated AST/ALTMedian age 57 yearsMulticenter phase 1 trialTreatment-emergent adverse eventsEmergent adverse eventsHBV/HCVSquamous cell skinPD-L1 therapyAge 57 yearsHIV viral loadAST/ALTPhase 1 trialCells/Cells/μL.Multicentric Castleman's diseaseAppropriate eligibility criteriaImmuno-oncology studiesNumber of cancers
2018
Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1
Emu B, Fessel J, Schrader S, Kumar P, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. New England Journal Of Medicine 2018, 379: 645-654. PMID: 30110589, DOI: 10.1056/nejmoa1711460.Peer-Reviewed Original ResearchConceptsPhase 3 studyHIV-1 infectionViral loadBackground regimenVirologic failureAdverse eventsWeek 25Multidrug-resistant HIV-1 infectionMDR HIV-1 infectionMean baseline viral loadMultidrug-resistant HIV-1Human immunodeficiency virus type 1Immunodeficiency virus type 1Control periodMultiple antiretroviral therapiesViral load decreaseCommon adverse eventsMean CD4 countPrimary end pointSerious adverse eventsBaseline viral loadProportion of patientsHIV-1 RNALimited treatment optionsVirus type 1
2017
Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients
Ishida JH, Patel A, Mehta AK, Gatault P, McBride JM, Burgess T, Derby MA, Snydman DR, Emu B, Feierbach B, Fouts AE, Maia M, Deng R, Rosenberger CM, Gennaro LA, Striano NS, Liao XC, Tavel JA. Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrobial Agents And Chemotherapy 2017, 61: 10.1128/aac.01794-16. PMID: 27872061, PMCID: PMC5278717, DOI: 10.1128/aac.01794-16.Peer-Reviewed Original ResearchConceptsHigh-risk kidney transplant recipientsKidney transplant recipientsCMV viremiaTransplant recipientsCMV diseaseCMV infectionCytomegalovirus infectionMonoclonal antibodiesCMV-seronegative recipientsCMV-seropositive donorsLess CMV diseasePlacebo-controlled trialTime of transplantKidney transplantationPlacebo groupAdverse eventsKidney transplantMedian timeSignificant complicationsPlaceboTreatment groupsPatientsViremiaInfectionWeeks
2015
Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of RG7667, an Anticytomegalovirus Combination Monoclonal Antibody Therapy, in Healthy Adults
Ishida JH, Burgess T, Derby MA, Brown PA, Maia M, Deng R, Emu B, Feierbach B, Fouts AE, Liao XC, Tavel JA. Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of RG7667, an Anticytomegalovirus Combination Monoclonal Antibody Therapy, in Healthy Adults. Antimicrobial Agents And Chemotherapy 2015, 59: 4919-4929. PMID: 26055360, PMCID: PMC4505204, DOI: 10.1128/aac.00523-15.Peer-Reviewed Original ResearchConceptsHealthy adultsPlacebo groupAdverse eventsMonoclonal antibodiesDose-proportional pharmacokineticsMost adverse eventsDose-escalation studyMonoclonal antibody therapyProportion of subjectsHuman monoclonal antibodyOverall pharmacokinetic profileLife-threatening diseasePhase 1Transplant recipientsCytomegalovirus infectionAntibody therapyImmunogenicity profileMultiple dosesAntibody responseImmunocompromised individualsPharmacokinetic profileSusceptible populationAdultsHost targetsTherapy
2012
Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial
Emu B, Luca D, Offutt C, Grogan JL, Rojkovich B, Williams MB, Tang MT, Xiao J, Lee JH, Davis JC. Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial. Arthritis Research & Therapy 2012, 14: r6. PMID: 22225620, PMCID: PMC3392792, DOI: 10.1186/ar3554.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArea Under CurveArthritis, RheumatoidChemokine CXCL13DiarrheaDose-Response Relationship, DrugDouble-Blind MethodFemaleHeadacheHumansInjections, IntravenousInjections, SubcutaneousLymphotoxin-alphaMaleMetabolic Clearance RateMiddle AgedSignal TransductionTreatment OutcomeYoung AdultConceptsRA patientsAdverse eventsDose phaseClinical activityBiologic activityMedian Disease Activity ScoreMajority of AEsLymphotoxin αACR70 response ratesActive RA patientsRA disease activityDisease Activity ScorePlacebo-controlled trialSerious adverse eventsRheumatoid arthritis (RA) pathogenesisC-reactive proteinNovel monoclonal antibodyDisease activityPlacebo groupArthritis pathogenesisSerum CXCL13Activity scoreClinical effectsMultiple dosesT cells