2021
458 First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC)
Schoenfeld A, Lee S, Paz-Ares L, Doger B, Gettinger S, Haefliger S, Orcurto A, Sukari A, Papa S, Rodriguez Moreno J, Finckenstein F, Jagasia M, Fiaz R, Sulur G, Chen G, Gontcharova V, He K. 458 First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC). 2021, a486-a487. DOI: 10.1136/jitc-2021-sitc2021.458.Peer-Reviewed Original ResearchNon-small cell lung cancerImmune checkpoint inhibitorsAdvanced non-small cell lung cancerDurable responsesPrior linesSystemic therapyMetastatic non-small cell lung cancerFirst-line immune checkpoint inhibitorsPrior immune checkpoint inhibitorsT cell receptor repertoireExpected safety profileExploratory biomarker analysisPhase 2 multicenterObjective response rateOpen-label studyComplete metabolic responsePD-L1 expressionMajority of patientsCell lung cancerTCR repertoire analysisOncogene-directed therapyBest percentage changeInstitutional review boardWarrants further investigationInformed consent formNTRK1 Fusions identified by non-invasive plasma next-generation sequencing (NGS) across 9 cancer types
Rolfo C, Drilon A, Hong D, McCoach C, Dowlati A, Lin JJ, Russo A, Schram AM, Liu SV, Nieva JJ, Nguyen T, Eshaghian S, Morse M, Gettinger S, Mobayed M, Goldberg S, Araujo-Mino E, Vidula N, Bardia A, Subramanian J, Sashital D, Stinchcombe T, Kiedrowski L, Price K, Gandara DR. NTRK1 Fusions identified by non-invasive plasma next-generation sequencing (NGS) across 9 cancer types. British Journal Of Cancer 2021, 126: 514-520. PMID: 34480094, PMCID: PMC8811064, DOI: 10.1038/s41416-021-01536-1.Peer-Reviewed Original ResearchConceptsPlasma next-generation sequencingNTRK1 fusionsTumor typesAdvanced-stage solid tumorsNTRK fusion-positive tumorsTarget resistance mechanismsTissue-based testingHigh positive predictive valuePrimary tumor typeIdentification of patientsNon-invasive screening methodNext-generation sequencingFusion-positive tumorsPositive predictive valueDurable responsesPediatric patientsNTRK fusionsDrivers of carcinogenesisClinical dataTRK inhibitorsClinical practiceCtDNA analysisPredictive valueSolid tumorsOncogenic driversProlonged Complete Response of Early Stage Primary Adenocarcinoma of the Lung to Nivolumab Monotherapy.
Unlu S, Grant MJ, Gettinger S, Adeniran A, Kluger HM. Prolonged Complete Response of Early Stage Primary Adenocarcinoma of the Lung to Nivolumab Monotherapy. Clinical Oncology Case Reports 2021, 4 PMID: 34382032, PMCID: PMC8353529.Peer-Reviewed Original ResearchMultiple primary malignant tumorsNivolumab monotherapyCheckpoint inhibitorsLung cancerHigh Programmed-Death Ligand 1 (PD-L1) expressionProgrammed Death Ligand 1 ExpressionNon-small cell lung cancerMultiple regional lymph nodesImmune checkpoint inhibitorsPD-1 inhibitorsLigand 1 expressionPrimary lung cancerEarly-stage diseaseRegional lymph nodesCell lung cancerPrimary malignant tumorsHigh-risk natureSystemic immunotherapyDurable responsesAdvanced melanomaComplete responseEffective immunotherapyLymph nodesMore patientsPrimary adenocarcinoma
2018
Safety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study
Horn L, Gettinger SN, Gordon MS, Herbst RS, Gandhi L, Felip E, Sequist LV, Spigel DR, Antonia SJ, Balmanoukian A, Cassier PA, Liu B, Kowanetz M, O'Hear C, Fassò M, Grossman W, Sandler A, Soria JC. Safety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study. European Journal Of Cancer 2018, 101: 201-209. PMID: 30077125, DOI: 10.1016/j.ejca.2018.06.031.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsBaseline PD-L1 expressionObjective response ratePD-L1 expressionPD-L1Immune cellsGrade treatment-related adverse eventsSurvival rateCell lung cancer cohortLong-term clinical benefitTumor-infiltrating immune cellsTumor cellsPhase IPrevious systemic therapySingle-agent atezolizumabCell lung cancerExploratory subgroup analysisLung cancer cohortAtezolizumab monotherapyAdverse eventsDurable responsesMedian durationSystemic therapyAnticancer immunityPD-1Nivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC
Gettinger S, Hellmann MD, Chow LQM, Borghaei H, Antonia S, Brahmer JR, Goldman JW, Gerber DE, Juergens RA, Shepherd FA, Laurie SA, Young TC, Li X, Geese WJ, Rizvi N. Nivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC. Journal Of Thoracic Oncology 2018, 13: 1363-1372. PMID: 29802888, DOI: 10.1016/j.jtho.2018.05.015.Peer-Reviewed Original ResearchConceptsAdvanced EGFR-mutant NSCLCEGFR-mutant NSCLCTreatment-related grade 3 toxicitiesEGFR-mutant advanced NSCLCProgression-free survival ratesEGFR T790M mutationEGFR tyrosine kinase inhibitorsGrade 3 toxicityObjective response rateTKI-naive patientsCompound EGFR mutationsT790M mutationTyrosine kinase inhibitorsImmune-related responsesInvestigator recordsAdvanced NSCLCDurable responsesUnacceptable toxicityComplete responseFourth patientDisease progressionEGFR mutationsMutant NSCLCTumor biopsiesNivolumabFive-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study.
Gettinger S, Horn L, Jackman D, Spigel D, Antonia S, Hellmann M, Powderly J, Heist R, Sequist LV, Smith DC, Leming P, Geese WJ, Yoon D, Li A, Brahmer J. Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study. Journal Of Clinical Oncology 2018, 36: 1675-1684. PMID: 29570421, DOI: 10.1200/jco.2017.77.0412.Peer-Reviewed Original ResearchConceptsLigand 1 expressionOverall survivalAdvanced NSCLCProgressive diseaseOS ratesLung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerLong-term OSPhase III studyProportion of patientsResponse Evaluation CriteriaKaplan-Meier methodLong-term survivorsCell lung cancerEarly phase INivolumab 1Nivolumab treatmentStable diseaseNonsquamous NSCLCAdverse eventsDurable responsesFirst doseFormer smokersIII study
2017
Circulating tumor DNA (ctDNA) to monitor treatment response and progression in patients treated with tyrosine kinase inhibitors (TKIs) and immunotherapy for EGFR-mutant non-small cell lung cancer (NSCLC).
Henick B, Goldberg S, Narayan A, Rossi C, Rodney S, Kole A, Politi K, Gettinger S, Herbst R, Patel A. Circulating tumor DNA (ctDNA) to monitor treatment response and progression in patients treated with tyrosine kinase inhibitors (TKIs) and immunotherapy for EGFR-mutant non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2017, 35: e20652-e20652. DOI: 10.1200/jco.2017.35.15_suppl.e20652.Peer-Reviewed Original ResearchNon-small cell lung cancerTyrosine kinase inhibitorsEGFR-mutant non-small cell lung cancerCtDNA levelsDisease progressionRadiographic progressionTKI therapyEGFR mutationsEGFR mutation-positive non-small cell lung cancerMutation-positive non-small cell lung cancerT790MAnti-PD-1 monotherapyEGFR mutation-positive patientsPD-1 inhibitor monotherapyEGFR-mutant NSCLC patientsSubset of patientsCell lung cancerMutation-positive patientsAssessment of responseLow ctDNA levelsChart reviewClinical characteristicsDurable responsesInhibitor monotherapyNSCLC patients
2014
B7-H1/PD-1 Blockade Therapy in Non–Small Cell Lung Cancer
Gettinger S, Herbst RS. B7-H1/PD-1 Blockade Therapy in Non–Small Cell Lung Cancer. The Cancer Journal 2014, 20: 281-289. PMID: 25098289, DOI: 10.1097/ppo.0000000000000063.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerAdvanced non-small cell lung cancerPhase III trialsCell lung cancerIII trialsPD-1Lung cancerClinical trialsPD-1/PD-L1 inhibitorsB7-H1/PDTumor PD-L1 expressionSevere autoimmune toxicityChemotherapy-naive patientsPD-L1 expressionPotential of immunotherapyPD-L1 inhibitorsDeath ligand 1Future clinical trialsNumber of antibodiesAutoimmune toxicityExpansion cohortBlockade therapyDurable responsesNSCLC patientsStandard therapy
2013
Clinical activity, safety, and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Spigel D, Gettinger S, Horn L, Herbst R, Gandhi L, Gordon M, Cruz C, Conkling P, Cassier P, Antonia S, Burris H, Fine G, Mokatrin A, Kowanetz M, Shen X, Chen D, Soria J. Clinical activity, safety, and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: 8008-8008. DOI: 10.1200/jco.2013.31.15_suppl.8008.Peer-Reviewed Original ResearchNon-small cell lung cancerObjective response ratePD-L1 tumorsPD-L1NSCLC ptsLung cancerNonsquamous non-small cell lung cancerMetastatic non-small cell lung cancerPD-L1 tumor statusAnti-cancer immune responsePD-L1 statusPD-L1 antibodiesCell lung cancerRapid tumor shrinkagePD rateArchival tumor samplesHuman lung cancerHuman monoclonal AbsNonsquamous histologyRECIST responseRECIST v1.1Prior radiotherapyDurable responsesMedian durationPrior surgeryA 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