2024
Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A
Gettinger S, Song Z, Reckamp K, Moscow J, Gray R, Wang V, McShane L, Rubinstein L, Patton D, Williams P, Hamilton S, Kong X, Tricoli J, Conley B, Arteaga C, Harris L, O'Dwyer P, Chen A, Flaherty K. Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A. JCO Precision Oncology 2024, 8: e2300725. PMID: 38986051, DOI: 10.1200/po.23.00725.Peer-Reviewed Original ResearchConceptsProgression-free survivalTyrosine kinase inhibitorsEGFR tyrosine kinase inhibitorsNCI-MATCHLung cancerGlioblastoma multiformeOverall survivalAdvanced non-small cell lung cancerNational Cancer Institute-Molecular AnalysisNon-small cell lung cancerEnd pointsTumor genomic testingTrial primary end pointPhase 2 trialPhase II trialSecondary end pointsPrimary end pointCell lung cancerCohort of patientsMedian OSStable diseaseAdenosquamous carcinomaProtocol therapyPartial responseArm ALifileucel, an Autologous Tumor-infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors
Schoenfeld A, Lee S, de Speville B, Gettinger S, Hafliger S, Sukari A, Papa S, Rodríguez-Moreno J, Finckenstein F, Fiaz R, Catlett M, Chen G, Qi R, Masteller E, Gontcharova V, He K. Lifileucel, an Autologous Tumor-infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors. Cancer Discovery 2024, 14: 1389-1402. PMID: 38563600, PMCID: PMC11294887, DOI: 10.1158/2159-8290.cd-23-1334.Peer-Reviewed Original ResearchMetastatic non-small cell lung cancerAdverse eventsResistance to immune checkpoint inhibitorsPD-L1-negative tumorsPhase 2 multicenter studyLow tumor mutational burdenTreatment-emergent adverse eventsNon-small cell lung cancerTime of data cutoffRefractory to prior therapyPD-L1-negativeImmune checkpoint inhibitorsResistance to immunotherapyTumor mutational burdenCell lung cancerMultiple organ failurePotential treatment optionCheckpoint inhibitorsPrior therapyData cutoffPatient diedSystemic therapyMutational burdenSTK11 mutationsCardiac failure
2023
MA15.07 NC318, an Anti-Siglec-15 Humanized mAb, Alone and in Combination with Pembrolizumab in Immunotherapy Pretreated NSCLC
Gettinger S, Goldberg S, Chiang A, Wilson F, Kim S, Rowen E, Gerrish H, Duffield E, Davies M, Dest V, Jackson R, Pope J, Myint H, Langermann S, Cheng W, Rimm D, Chen L, Herbst R. MA15.07 NC318, an Anti-Siglec-15 Humanized mAb, Alone and in Combination with Pembrolizumab in Immunotherapy Pretreated NSCLC. Journal Of Thoracic Oncology 2023, 18: s155. DOI: 10.1016/j.jtho.2023.09.224.Peer-Reviewed Original ResearchFirst-Line Treatment of Driver-Negative Non–Small Cell Lung Cancer
Kim S, Gettinger S. First-Line Treatment of Driver-Negative Non–Small Cell Lung Cancer. Hematology/Oncology Clinics Of North America 2023, 37: 557-573. PMID: 37150586, DOI: 10.1016/j.hoc.2023.02.008.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerLung cancerAdvanced non-small cell lung cancerFirst-line settingFirst-line treatmentStandard of careCombination immunotherapyImmunotherapy monotherapyPD-L1Immunotherapy responseLine treatmentSmoking statusTreatment choiceTrial dataCancerImmunotherapyRegimensCliniciansTreatmentChemoimmunotherapyMonotherapyCareNovel Approaches for Dynamic Visualization of Adverse Event Data in Oncology Clinical Trials: A Case Study Using Immunotherapy Trial S1400-I (SWOG)
Lee S, Fan W, Wang A, Vaidya R, Redman M, Gettinger S, Bazhenova L, Herbst R, Hershman D, Unger J. Novel Approaches for Dynamic Visualization of Adverse Event Data in Oncology Clinical Trials: A Case Study Using Immunotherapy Trial S1400-I (SWOG). JCO Clinical Cancer Informatics 2023, 7: e2200165. PMID: 37084329, PMCID: PMC10281446, DOI: 10.1200/cci.22.00165.Peer-Reviewed Original ResearchConceptsSystem organ classAdverse event dataRandomized phase III trialPhase III trialsCell lung cancerOncology clinical trialsOverall toxicity profileIII trialsNeurologic toxicityTreatment armsCardiac toxicityLung cancerClinical trialsGrade 3High prevalenceOrgan classToxicity profileNivolumabTreatment groupsStage IVEndocrine toxicityType of AEToxicity typesAE termsIpilimumabNCCN Guidelines® Insights: Non-Small Cell Lung Cancer, Version 2.2023.
Ettinger D, Wood D, Aisner D, Akerley W, Bauman J, Bharat A, Bruno D, Chang J, Chirieac L, DeCamp M, Dilling T, Dowell J, Durm G, Gettinger S, Grotz T, Gubens M, Hegde A, Lackner R, Lanuti M, Lin J, Loo B, Lovly C, Maldonado F, Massarelli E, Morgensztern D, Ng T, Otterson G, Patel S, Patil T, Polanco P, Riely G, Riess J, Schild S, Shapiro T, Singh A, Stevenson J, Tam A, Tanvetyanon T, Yanagawa J, Yang S, Yau E, Gregory K, Hughes M. NCCN Guidelines® Insights: Non-Small Cell Lung Cancer, Version 2.2023. Journal Of The National Comprehensive Cancer Network 2023, 21: 340-350. PMID: 37015337, DOI: 10.6004/jnccn.2023.0020.Peer-Reviewed Original ResearchSafety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer
Rudin C, Cervantes A, Dowlati A, Besse B, Ma B, Costa D, Schmid P, Heist R, Villaflor V, Spahn J, Li S, Cha E, Riely G, Gettinger S. Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer. ESMO Open 2023, 8: 101160. PMID: 36871392, PMCID: PMC10163154, DOI: 10.1016/j.esmoop.2023.101160.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCell lung cancerAdverse eventsLung cancerClinical activityEpidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) efficacyGrade 3 treatment-related adverse eventsEGFR TKI-naive patientsMedian progression-free survivalEGFR mutation-positive NSCLCAdvanced EGFR mutation-positive NSCLCTyrosine kinase inhibitor efficacyDurable clinical activityTolerable safety profileMedian overall survivalMedian response durationObjective response ratePhase Ib trialSerious adverse eventsProgression-free survivalStage 2 patientsMutation-positive NSCLCEGFR-mutant NSCLCTKI-naive patientsAtezolizumab 1200PP01.40 Target Lesion Response and Outcomes in Patients Treated with Brigatinib vs Crizotinib in ALTA-1L
Camidge D, Kim H, Ahn M, Yang J, Han J, Hochmair M, Lee K, Delmonte A, Campelo M, Kim D, Griesinger F, Felip E, Califano R, Spira A, Thomas M, Gettinger S, Tiseo M, Liu Y, Zhang P, Popat S. PP01.40 Target Lesion Response and Outcomes in Patients Treated with Brigatinib vs Crizotinib in ALTA-1L. Journal Of Thoracic Oncology 2023, 18: e27. DOI: 10.1016/j.jtho.2022.09.066.Peer-Reviewed Original ResearchQuality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I
Unger J, Qian L, Redman M, Tavernier S, Minasian L, Sigal E, Papadimitrakopoulou V, Leblanc M, Cleeland C, Dzingle S, Summers T, Chao H, Madhusudhana S, Villaruz L, Crawford J, Gray J, Kelly K, Gandara D, Bazhenova L, Herbst R, Gettinger S, Moinpour C. Quality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I. Journal Of The National Cancer Institute 2023, 115: 437-446. PMID: 36625510, PMCID: PMC10086628, DOI: 10.1093/jnci/djad003.Peer-Reviewed Original ResearchConceptsQuality of lifeComposite risk modelAppetite lossSeverity scoreWeek 13Advanced squamous cell lung cancerWeek 7Baseline patient-reported outcomesRandomized phase III trialSquamous cell lung cancerPhase III trialsRisk of progressionShortness of breathCell lung cancerPatient-reported outcomesRisk of deathMultivariable linear regressionEffect of treatmentEvaluable patientsPrimary endpointIII trialsOverall survivalMedian ageAdvanced cancerPrognostic relevance
2022
2MO First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) in metastatic non-small cell lung cancer (mNSCLC): Clinical outcomes and biomarker analyses from CheckMate 592
Gettinger S, Schenker M, De Langen J, Fischer J, Morgensztern D, Ciuleanu T, Beck T, De Castro Carpeno J, Schumann C, Yang X, Telivala B, Deschepper K, Nadal E, Schalper K, Spires T, Balli D, Nassar A, Karam S, Bhingare A, Spigel D. 2MO First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) in metastatic non-small cell lung cancer (mNSCLC): Clinical outcomes and biomarker analyses from CheckMate 592. Immuno-Oncology Technology 2022, 16: 100107. DOI: 10.1016/j.iotech.2022.100107.Peer-Reviewed Original Research235 (PB115) Phase II trial of afatinib in patients with EGFR-mutated solid tumors excluding lung cancer: results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A
Reckamp K, Song Z, Gettinger S, Mitchell E, Wright J, Moscow J, Gray R, Wang V, McShane L, Rubinstein L, Patton D, Williams P, Hamilton S, Conley B, Arteaga C, Harris L, O’Dwyer P, Chen A, Flaherty K. 235 (PB115) Phase II trial of afatinib in patients with EGFR-mutated solid tumors excluding lung cancer: results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A. European Journal Of Cancer 2022, 174: s84-s85. DOI: 10.1016/s0959-8049(22)01023-1.Peer-Reviewed Original ResearchLong-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials
Gettinger SN, Huber RM, Kim DW, Bazhenova L, Hansen KH, Tiseo M, Langer CJ, Rodríguez L, West HL, Reckamp KL, Weiss GJ, Smit EF, Hochmair MJ, Kim SW, Ahn MJ, Kim ES, Groen HJM, Pye J, Liu Y, Zhang P, Vranceanu F, Camidge DR. Long-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials. JTO Clinical And Research Reports 2022, 3: 100385. PMID: 36065449, PMCID: PMC9440305, DOI: 10.1016/j.jtocrr.2022.100385.Peer-Reviewed Original ResearchProgression-free survivalPhase 1/2 studyMedian investigator-assessed progression-free survivalInvestigator-assessed progression-free survivalMedian overall survivalPhase 2 trialLong-term efficacyOverall survivalPhase 1/2Arm AStudy endMedian intracranial progression-free survivalIntracranial progression-free survivalRandomized phase 2 trialNew safety signalsIndependent review committeeArm B.Advanced malignanciesBrain metastasesManageable safetyArm BPositive NSCLCSafety signalsNSCLCPatientsBrief Report: Safety and Antitumor Activity of Alectinib Plus Atezolizumab From a Phase 1b Study in Advanced ALK-Positive NSCLC
Kim DW, Gadgeel S, Gettinger SN, Riely GJ, Oxnard GR, Mekhail T, Schmid P, Dowlati A, Heist RS, Wozniak AJ, Singh J, Cha E, Spahn J, Ou SI. Brief Report: Safety and Antitumor Activity of Alectinib Plus Atezolizumab From a Phase 1b Study in Advanced ALK-Positive NSCLC. JTO Clinical And Research Reports 2022, 3: 100367. PMID: 35875467, PMCID: PMC9304608, DOI: 10.1016/j.jtocrr.2022.100367.Peer-Reviewed Original ResearchTreatment-related adverse eventsPhase 1b studyAdverse eventsPositive NSCLCAntitumor activityGrade 3 treatment-related adverse eventsPreferred first-line treatment optionAdvanced ALK-positive NSCLCMedian progression-free survivalStage IIIB/IVFirst-line treatment optionDose of alectinibIIIB/IVImmune checkpoint inhibitorsMedian overall survivalObjective response rateProgression-free survivalDose-limiting toxicityALK-positive NSCLCAtezolizumab 1200Checkpoint inhibitorsStarting doseMedian durationOverall survivalCombination regimensMultiomics profiling and association with molecular and immune features in association with benefits from immunotherapy for patients with previously treated stage IV or recurrent squamous cell lung cancer from the phase III SWOG LungMAP S1400I trial.
Parra E, Duose D, Zhang J, Redman M, Segura R, Marques-Piubelli M, Fernandez C, Zhang B, Lindsay J, Moravec R, Kannan K, Luthra R, Alatrash G, Herbst R, Wistuba I, Gettinger S, Bazhenova L, Lee J, Zhang J, Haymaker C. Multiomics profiling and association with molecular and immune features in association with benefits from immunotherapy for patients with previously treated stage IV or recurrent squamous cell lung cancer from the phase III SWOG LungMAP S1400I trial. Journal Of Clinical Oncology 2022, 40: 9046-9046. DOI: 10.1200/jco.2022.40.16_suppl.9046.Peer-Reviewed Original ResearchImmune checkpoint blockadeSquamous cell carcinomaT cellsBetter PFSLung cancerRecurrent squamous cell lung cancerTumor compartmentsLog-rank test analysisMetastatic lung squamous cell carcinomaSquamous cell lung cancerPD-1/CTLALung squamous cell carcinomaImmune cell scoreSingle-agent nivolumabDurable clinical benefitCD8 T cellsCell lung cancerCytotoxic immune cellsPositive clinical outcomesCell phenotypeFFPE tumor tissueBetter OSEligible patientsImmunogenomic profilingWorse OSDynamic changes in serum analyte levels associated with clinical outcome in squamous cell lung cancer trial SWOG Lung-MAP S1400I of nivolumab ± ipilimumab.
Gonzalez-Kozlova E, Huang H, Redman M, Herbst R, Gettinger S, Bazhenova L, Xie H, Patel M, Nie K, Harris J, Argueta K, Cerami E, Hong J, Biswas R, Van Nostrand S, Kelly K, Moravec R, Del Valle D, Kim-Schulze S, Gnjatic S. Dynamic changes in serum analyte levels associated with clinical outcome in squamous cell lung cancer trial SWOG Lung-MAP S1400I of nivolumab ± ipilimumab. Journal Of Clinical Oncology 2022, 40: 9044-9044. DOI: 10.1200/jco.2022.40.16_suppl.9044.Peer-Reviewed Original ResearchImmune checkpoint blockadeSerial blood specimensObjective responseOverall survivalLung cancerBlood specimensCox modelRecurrent squamous cell lung cancerWk 3Randomized phase III trialSquamous cell lung cancerPhase III trialsBest objective responseCell lung cancerRisk of deathProtein levelsSerum analyte levelsIndicators of outcomeLinear mixed modelsSerum protein levelsProximity extension assayMeasurement of bloodEligible patientsLower IL6Checkpoint blockadeAssociation of depth of target lesion response to brigatinib with outcomes in patients with ALK inhibitor-naive ALK+ NSCLC in ALTA-1L.
Camidge D, Kim H, Ahn M, Yang J, Han J, Hochmair M, Lee K, Delmonte A, Campelo R, Kim D, Griesinger F, Felip E, Califano R, Spira A, Thomas M, Gettinger S, Tiseo M, Liu Y, Zhang P, Popat S. Association of depth of target lesion response to brigatinib with outcomes in patients with ALK inhibitor-naive ALK+ NSCLC in ALTA-1L. Journal Of Clinical Oncology 2022, 40: 9072-9072. DOI: 10.1200/jco.2022.40.16_suppl.9072.Peer-Reviewed Original ResearchBlinded independent review committeeTarget lesion assessmentTarget lesion responseLesion shrinkageLesion responseLesion assessmentCochran-Armitage trend analysisRandomized phase 3 trialShrinkage groupPhase 3 trialDepth of responseIndependent review committeeLonger median timeMajority of ptsAssociation of depthRECIST v1.1PFS eventsMedian ageOS ratesMedian timeStudy endTarget lesionsLower riskDeep responsesBrigatinibNon-Small Cell Lung Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology.
Ettinger DS, Wood DE, Aisner DL, Akerley W, Bauman JR, Bharat A, Bruno DS, Chang JY, Chirieac LR, D'Amico TA, DeCamp M, Dilling TJ, Dowell J, Gettinger S, Grotz TE, Gubens MA, Hegde A, Lackner RP, Lanuti M, Lin J, Loo BW, Lovly CM, Maldonado F, Massarelli E, Morgensztern D, Ng T, Otterson GA, Pacheco JM, Patel SP, Riely GJ, Riess J, Schild SE, Shapiro TA, Singh AP, Stevenson J, Tam A, Tanvetyanon T, Yanagawa J, Yang SC, Yau E, Gregory K, Hughes M. Non-Small Cell Lung Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. Journal Of The National Comprehensive Cancer Network 2022, 20: 497-530. PMID: 35545176, DOI: 10.6004/jnccn.2022.0025.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerNCCN Clinical Practice GuidelinesCell lung cancerClinical practice guidelinesLung cancerPractice guidelinesMetastatic non-small cell lung cancerMetastatic lung cancerNCCN guidelinesPrimary treatmentTargeted therapyActionable mutationsPatientsCancerSubsequent treatmentTherapyOncologyTreatmentGuidelinesImmunotherapyRelapseDiagnosisMicrowave Ablation versus Stereotactic Body Radiotherapy for Stage I Non–Small Cell Lung Cancer: A Cost-Effectiveness Analysis
Wu X, Uhlig J, Blasberg JD, Gettinger SN, Suh RD, Solomon SB, Kim HS. Microwave Ablation versus Stereotactic Body Radiotherapy for Stage I Non–Small Cell Lung Cancer: A Cost-Effectiveness Analysis. Journal Of Vascular And Interventional Radiology 2022, 33: 964-971.e2. PMID: 35490932, DOI: 10.1016/j.jvir.2022.04.019.Peer-Reviewed Original ResearchNivolumab Plus Ipilimumab for Previously Treated Stage IV Squamous Cell Lung Cancer—Reply
Gettinger S, Redman MW, Herbst RS. Nivolumab Plus Ipilimumab for Previously Treated Stage IV Squamous Cell Lung Cancer—Reply. JAMA Oncology 2022, 8: 1-1. PMID: 35142793, DOI: 10.1001/jamaoncol.2021.7790.Peer-Reviewed Original Research29P Brigatinib (BRG) vs crizotinib (CRZ) in anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor-naive ALK+ non-small cell lung cancer (NSCLC): ALTA-1L final results
Tiseo M, Popat S, Kim H, Ahn M, Yang J, Han J, Hochmair M, Lee K, Delmonte A, Campelo M, Kim D, Griesinger F, Felip E, Califano R, Spira A, Gettinger S, Lin H, Liu Y, Vranceanu F, Camidge D. 29P Brigatinib (BRG) vs crizotinib (CRZ) in anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor-naive ALK+ non-small cell lung cancer (NSCLC): ALTA-1L final results. Annals Of Oncology 2022, 33: s44-s45. DOI: 10.1016/j.annonc.2022.02.038.Peer-Reviewed Original Research