2017
Continued use of afatinib with the addition of cetuximab after progression on afatinib in patients with EGFR mutation-positive non-small-cell lung cancer and acquired resistance to gefitinib or erlotinib
Horn L, Gettinger S, Camidge DR, Smit EF, Janjigian YY, Miller VA, Pao W, Freiwald M, Fan J, Wang B, Chand VK, Groen HJM. Continued use of afatinib with the addition of cetuximab after progression on afatinib in patients with EGFR mutation-positive non-small-cell lung cancer and acquired resistance to gefitinib or erlotinib. Lung Cancer 2017, 113: 51-58. PMID: 29110849, DOI: 10.1016/j.lungcan.2017.08.014.Peer-Reviewed Original ResearchMeSH KeywordsAdultAfatinibAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCetuximabCohort StudiesDiarrheaDisease ProgressionDrug Resistance, NeoplasmErbB ReceptorsErlotinib HydrochlorideExanthemaFemaleGefitinibHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMutationQuinazolinesConceptsEGFR mutation-positive NSCLCEpidermal growth factor receptorMutation-positive NSCLCCell lung cancerAdverse eventsAfatinib monotherapyMedian PFSLung cancerDrug-related grade 3/4 adverse eventsFrequent drug-related adverse eventsDrug-related adverse eventsGrade 3/4 adverse eventsAddition of cetuximabIntolerable adverse eventsPhase Ib trialT790M-negative tumorsPercent of patientsPredictable safety profileAfatinib dailyGrowth factor receptorIb trialSafety profileClinical activityDry skinSeparate cohort
2015
3094 Nivolumab (NIVO) safety profile: Summary of findings from trials in patients (pts) with advanced squamous (SQ) non-small cell lung cancer (NSCLC)
Gettinger S, Horn L, Ramalingam S, Spigel D, Paz-Ares L, Paik P, Reck M, Reckamp K, Mazières J, Stinchcombe T, Lynch M, Brahmer J. 3094 Nivolumab (NIVO) safety profile: Summary of findings from trials in patients (pts) with advanced squamous (SQ) non-small cell lung cancer (NSCLC). European Journal Of Cancer 2015, 51: s631. DOI: 10.1016/s0959-8049(16)31735-x.Peer-Reviewed Original Research
2014
Dual Inhibition of EGFR with Afatinib and Cetuximab in Kinase Inhibitor–Resistant EGFR-Mutant Lung Cancer with and without T790M Mutations
Janjigian YY, Smit EF, Groen HJ, Horn L, Gettinger S, Camidge DR, Riely GJ, Wang B, Fu Y, Chand VK, Miller VA, Pao W. Dual Inhibition of EGFR with Afatinib and Cetuximab in Kinase Inhibitor–Resistant EGFR-Mutant Lung Cancer with and without T790M Mutations. Cancer Discovery 2014, 4: 1036-1045. PMID: 25074459, PMCID: PMC4155006, DOI: 10.1158/2159-8290.cd-14-0326.Peer-Reviewed Original ResearchConceptsEGFR-mutant lung cancerT790M mutationLung cancerM mutationGrade 3/4 adverse eventsMedian progression-free survivalEGFR T790M mutationErlotinib/gefitinibRobust clinical activityT790M-negative tumorsManageable safety profileObjective response ratePhase Ib studyProgression-free survivalMutant lung cancerGefitinib/erlotinibFirst clinical proofReversible EGFR inhibitorsAdverse eventsMedian durationObjective responseSafety profilePreclinical hypothesisEGFR mutationsClinical activity
2013
Survival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC).
Brahmer J, Horn L, Antonia S, Spigel D, Gandhi L, Sequist L, Sankar V, Ahlers C, Wigginton J, Kollia G, Gupta A, Gettinger S. Survival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: 8030-8030. DOI: 10.1200/jco.2013.31.15_suppl.8030.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerPhase I trialOverall survivalMedian OSI trialCommon drug-related AEsDrug-related AEsMedian overall survivalPrior chemotherapy regimenAcceptable safety profilePhase 1 studyCell lung cancerPD-1 receptorImmune checkpoint receptorsDrug-related deathsT cell activationNSCLC ptsOS benefitChemotherapy regimenDose cohortsCheckpoint receptorsDeath-1Safety profileDiscontinuation criteriaNivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial.
Topalian S, Sznol M, Brahmer J, McDermott D, Smith D, Gettinger S, Taube J, Drake C, Pardoll D, Powderly J, Carvajal R, Sosman J, Atkins M, Antonia S, Spigel D, Lawrence D, Kollia G, Gupta A, Wigginton J, Hodi F. Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial. Journal Of Clinical Oncology 2013, 31: 3002-3002. DOI: 10.1200/jco.2013.31.15_suppl.3002.Peer-Reviewed Original ResearchAdvanced solid tumorsLong-term safetySolid tumorsNon-small cell lung cancerLong-term safety profileDrug-related AEsDrug-related pneumonitisCo-inhibitory receptorsPhase III trialsPhase I trialCell lung cancerOngoing clinical developmentActivated T cellsCohort expansionMedian OSRECIST 1.0Efficacy outcomesUnacceptable toxicityIII trialsDeath-1Dose escalationI trialPD-1G3/G4Safety profileA phase I study of nivolumab (anti-PD-1; BMS-936558, ONO-4538) plus platinum-based doublet chemotherapy (PT-doublet) in chemotherapy-naive non-small cell lung cancer (NSCLC) patients (pts).
Rizvi N, Antonia S, Chow L, Brahmer J, Juergens R, Borghaei H, Shepherd F, Laurie S, Gerber D, Goldman J, Shen Y, Harbison C, Alaparthy S, Chen A, Gettinger S. A phase I study of nivolumab (anti-PD-1; BMS-936558, ONO-4538) plus platinum-based doublet chemotherapy (PT-doublet) in chemotherapy-naive non-small cell lung cancer (NSCLC) patients (pts). Journal Of Clinical Oncology 2013, 31: 8072-8072. DOI: 10.1200/jco.2013.31.15_suppl.8072.Peer-Reviewed Original ResearchNSCLC ptsArm APhase INon-small cell lung cancer patientsPlatinum-based doublet chemotherapyCell lung cancer patientsCarboplatin/paclitaxelIncidence of DLTTolerable safety profileGemcitabine/cisplatinLung cancer patientsDe-escalation designWk of dosingGr 3Doublet chemotherapyNivolumab dosesStandard dosingAspergillus pneumoniaChemotherapy regimenDose cohortsDurable responsesArm BMaintenance treatmentConfirmation of responseSafety profile
2010
Phase 1 Study of Aflibercept Administered Subcutaneously to Patients with Advanced Solid Tumors
Tew WP, Gordon M, Murren J, Dupont J, Pezzulli S, Aghajanian C, Sabbatini P, Mendelson D, Schwartz L, Gettinger S, Psyrri A, Cedarbaum JM, Spriggs DR. Phase 1 Study of Aflibercept Administered Subcutaneously to Patients with Advanced Solid Tumors. Clinical Cancer Research 2010, 16: 358-366. PMID: 20028764, PMCID: PMC4211604, DOI: 10.1158/1078-0432.ccr-09-2103.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsSolid tumorsDrug-related grade 3Vascular endothelial growth factor trapDose of afliberceptDose-escalation studyDose-proportional increaseInjection site reactionsPhase 1 studyManageable side effectsVascular endothelial growth factorWarrants further evaluationFavorable pharmacokinetic profileProgression of diseaseNovel antiangiogenic agentsEndothelial growth factorCommon toxicitiesStable diseasePulmonary embolismCerebral ischemiaSubcutaneous dosesSafety profileSingle doseSite reactionsSubcutaneous formulation