2022
Bempegaldesleukin plus Nivolumab in First-line Metastatic Urothelial Carcinoma: Results from PIVOT-02
Siefker-Radtke AO, Cho DC, Diab A, Sznol M, Bilen MA, Balar AV, Grignani G, Puente E, Tang L, Chien D, Hoch U, Choudhury A, Yu D, Currie SL, Tagliaferri MA, Zalevsky J, Hurwitz ME, Tannir NM. Bempegaldesleukin plus Nivolumab in First-line Metastatic Urothelial Carcinoma: Results from PIVOT-02. European Urology 2022, 82: 365-373. PMID: 35643589, DOI: 10.1016/j.eururo.2022.05.002.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsMetastatic urothelial carcinomaObjective response rateProgression-free survivalExploratory biomarker analysisOverall survivalUrothelial carcinomaGrade 3/4 treatment-related adverse eventsResponse rateMedian progression-free survivalTreatment-related side effectsCisplatin-ineligible patientsMedian overall survivalPhase 1/2 studyComplete response rateFirst-line treatmentSubset of patientsChemotherapy-free treatmentTumor response assessmentSingle-arm designUnivariate logistic regressionBiomarker analysisMeasurable diseaseMedian durationTreatment landscape
2021
Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma
Diab A, Tykodi SS, Daniels GA, Maio M, Curti BD, Lewis KD, Jang S, Kalinka E, Puzanov I, Spira AI, Cho DC, Guan S, Puente E, Nguyen T, Hoch U, Currie SL, Lin W, Tagliaferri MA, Zalevsky J, Sznol M, Hurwitz ME. Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma. Journal Of Clinical Oncology 2021, 39: 2914-2925. PMID: 34255535, PMCID: PMC8425826, DOI: 10.1200/jco.21.00675.Peer-Reviewed Original ResearchConceptsProgression-free survivalImmune-mediated adverse eventsMedian progression-free survivalObjective response rateMetastatic melanomaOverall survivalResponse rateAdverse eventsTarget lesionsGrade 3Stage III/IV melanomaEnd pointPhase II cohortComplete response rateMedian overall survivalPrimary end pointRadiologic evidenceUntreated patientsDurable responsesPolyfunctional responsesOS ratesBlood biomarkersComplete clearanceMedian changeExploratory biomarkers
2020
Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design
Khushalani NI, Diab A, Ascierto PA, Larkin J, Sandhu S, Sznol M, Koon HB, Jarkowski A, Zhou M, Statkevich P, Geese WJ, Long GV. Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design. Future Oncology 2020, 16: 2165-2175. PMID: 32723187, DOI: 10.2217/fon-2020-0351.Peer-Reviewed Original ResearchConceptsMetastatic melanomaKey secondary end pointEnd pointSafety/tolerabilityObjective response ratePD-1 inhibitorsPrimary end pointSecondary end pointsFirst-line therapyProgression-free survivalNatural killer cellsOverall survivalSurvival benefitAdvanced melanomaKiller cellsClinical trialsEffector TClinical activityNivolumabBempegaldesleukinResponse rateMelanomaPathway agonistStudy designPhase III
2017
PD-L1 Studies Across Tumor Types, Its Differential Expression and Predictive Value in Patients Treated with Immune Checkpoint Inhibitors
Kluger HM, Zito CR, Turcu G, Baine M, Zhang H, Adeniran A, Sznol M, Rimm DL, Kluger Y, Chen L, Cohen JV, Jilaveanu LB. PD-L1 Studies Across Tumor Types, Its Differential Expression and Predictive Value in Patients Treated with Immune Checkpoint Inhibitors. Clinical Cancer Research 2017, 23: 4270-4279. PMID: 28223273, PMCID: PMC5540774, DOI: 10.1158/1078-0432.ccr-16-3146.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPD-L1 expressionRenal cell carcinomaPD-1 inhibitorsCell carcinomaImmune-infiltrating cellsMelanoma patientsPD-L1Tumor cellsTumor typesTumor-associated inflammatory cellsCTLA-4 inhibitorsCell lung cancerRenal cell carcinoma cellsHigh response rateClin Cancer ResCell linesMelanoma tumor cellsPD-1Multivariable analysisNSCLC specimensInflammatory cellsLung cancerTissue microarrayResponse rate
2016
Efficacy and Safety of Nivolumab Alone or in Combination With Ipilimumab in Patients With Mucosal Melanoma: A Pooled Analysis
D'Angelo SP, Larkin J, Sosman JA, Lebbé C, Brady B, Neyns B, Schmidt H, Hassel JC, Hodi FS, Lorigan P, Savage KJ, Miller WH, Mohr P, Marquez-Rodas I, Charles J, Kaatz M, Sznol M, Weber JS, Shoushtari AN, Ruisi M, Jiang J, Wolchok JD. Efficacy and Safety of Nivolumab Alone or in Combination With Ipilimumab in Patients With Mucosal Melanoma: A Pooled Analysis. Journal Of Clinical Oncology 2016, 35: 226-235. PMID: 28056206, PMCID: PMC5559888, DOI: 10.1200/jco.2016.67.9258.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalObjective response rateProgression-free survivalMucosal melanomaCutaneous melanomaNivolumab monotherapyAnti-programmed death-1 therapyResponse rateTreatment-related adverse eventsSafety of nivolumabPhase III trialsRare melanoma subtypeNivolumab AloneAdverse eventsIII trialsSafety profileAggressive malignancyCombination therapyConventional therapyPooled analysisPoor responseClinical studiesGrade 3IpilimumabMelanoma subtypes
2011
Molecular Markers of Response to Treatment for Melanoma
Sznol M. Molecular Markers of Response to Treatment for Melanoma. The Cancer Journal 2011, 17: 127-133. PMID: 21427556, DOI: 10.1097/ppo.0b013e318212dd5a.Peer-Reviewed Original ResearchConceptsImmune therapyAnti-tumor immune responseInitial high response rateStandard of careFraction of patientsUseful predictive biomarkerHigh response rateMost patientsMetastatic melanomaPredictive biomarkersClinical activityImmune responseIndividual patientsPotent small molecule inhibitorsDurable benefitMultiple active agentsSmall molecule inhibitorsResponse ratePatientsMutant BRAFOverall populationTherapyMolecule inhibitorsMelanomaTumors
2010
A phase 2 trial of dasatinib in advanced melanoma
Kluger HM, Dudek AZ, McCann C, Ritacco J, Southard N, Jilaveanu LB, Molinaro A, Sznol M. A phase 2 trial of dasatinib in advanced melanoma. Cancer 2010, 117: 2202-2208. PMID: 21523734, PMCID: PMC3116034, DOI: 10.1002/cncr.25766.Peer-Reviewed Original ResearchConceptsProgression-free survivalC-kit mutationsPhase 2 trialResponse ratePartial responseMedian progression-free survivalMelanoma cell proliferationDaily dasatinibMucosal primaryPFS ratesStarting dosageCommon toxicitiesUnresectable melanomaAdvanced melanomaPleural effusionMelanoma patientsPredictive biomarkersMinor responseCombination trialsTumor assessmentDose reductionPatientsPrespecified endpointsDasatinibMelanomaMelanoma: A model for testing new agents in combination therapies
Ascierto PA, Streicher HZ, Sznol M. Melanoma: A model for testing new agents in combination therapies. Journal Of Translational Medicine 2010, 8: 38. PMID: 20406483, PMCID: PMC2873374, DOI: 10.1186/1479-5876-8-38.Peer-Reviewed Original ResearchConceptsC-Kit inhibitorsAdvanced melanomaImmune modulatorsIntroduction of interferonNew single agentsMulti-modality treatmentReliable predictive biomarkersSelection of patientsAdoptive cellular therapyAnti-angiogenesis agentsValidation of PatientAdditional molecular targetsImmunologic modulatorsAdvanced diseaseCombination therapyPredictive biomarkersIL-2High success rateIndividual patientsNew agentsSmall molecule inhibitorsPatientsSingle agentResponse rateAnticancer modalities