2025
Elevated ctDNA Tumor Fraction Is Associated with Improved Mutation Detection but Worse Overall Survival in Advanced Non-Small Cell Lung Cancer: a Lung-MAP Study.
Mack P, Redman M, Tukachinsky H, Kozono D, Minichiello K, Dragnev K, Tolba K, Neal J, Madison R, Waqar S, Aggarwal C, Hirsch F, Patel J, Herbst R, Chiang A, Reckamp K, Kelly K, Borghaei H, Gray J, Gandara D. Elevated ctDNA Tumor Fraction Is Associated with Improved Mutation Detection but Worse Overall Survival in Advanced Non-Small Cell Lung Cancer: a Lung-MAP Study. Clinical Cancer Research 2025 PMID: 40465842, DOI: 10.1158/1078-0432.ccr-24-3658.Peer-Reviewed Original ResearchCirculating tumor DNAPositive percent agreementOverall survivalTumor fractionAdvanced NSCLCMutation detectionAdvanced non-small cell lung cancerAssociated with significantly worse overall survivalMaximum somatic allele frequencyNon-small cell lung cancerSignificantly worse overall survivalTF levelsCopy number gainCell lung cancerPaired tumor tissuesPatient overall survivalVariant allele frequencyMutational concordanceTumor aneuploidyAllele frequenciesFoundation MedicineTumor DNAClinical outcomesPlasma levelsLung cancerPRAGMATICA-LUNG (SWOG S2302): A prospective, randomized study of ramucirumab plus pembrolizumab versus standard of care for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer.
Dragnev K, Redman M, Reckamp K, Khalil M, Henick B, Moon J, Ahmadzai P, LeBlanc M, Carrizosa D, Hesketh P, Sigal E, Allen J, Saltos A, Faller B, Herbst R, Blanke C, Gray J. PRAGMATICA-LUNG (SWOG S2302): A prospective, randomized study of ramucirumab plus pembrolizumab versus standard of care for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer. Journal Of Clinical Oncology 2025, 43: lba8671-lba8671. DOI: 10.1200/jco.2025.43.17_suppl.lba8671.Peer-Reviewed Original ResearchSquamous cell carcinomaOverall survivalAdvanced NSCLCRecurrent non-small cell lung cancerRandomized phase III trialMedian of follow-upNon-small cell lung cancerPhase II randomized studyInterim analysisTreated with ICIPlatinum-based therapyTreated with immunotherapyPhase III trialsCell lung cancerLong follow-upStandard of careChemotherapy-freeHistological subgroupsNon-SCCIII trialsCell carcinomaMedian ageToxicity profileRandomized studyAdverse eventsClinical features associated with an exceptional response to immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC).
Nie Y, Wurtz A, Li F, Schalper K, Duffield E, Rowen E, Gerrish H, Chiang A, Goldberg S, Wilson F, Kim S, Grant M, Sabbath K, Talsania A, Lasala J, Russo A, Politi K, Herbst R, Gettinger S. Clinical features associated with an exceptional response to immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2025, 43: 8544-8544. DOI: 10.1200/jco.2025.43.16_suppl.8544.Peer-Reviewed Original ResearchMetastatic non-small cell lung cancerNon-small cell lung cancerMonocyte-to-lymphocyte ratioAbsolute lymphocyte countPre-treatment absolute lymphocyte countResponse to immunotherapyCell lung cancerExceptional respondersLiver metastasesImmunotherapy responseAdvanced non-small cell lung cancerLung cancerTumor PD-L1 expressionPresence of brain metastasesInfluence immunotherapy responsivenessPD-L1 expressionSubsets of patientsTumor microenvironment analysisYale Cancer CenterTumor tissue analysisIRB-approved protocolLong-term survivalConcurrent chemotherapyBrain metastasesClinicopathological predictorsSWOG S2302, PRAGMATICA-LUNG: A pragmatic trial designed to increase participant representation.
Reckamp K, Redman M, Dragnev K, Khalil M, Henick B, Moon J, Ahmadzai P, LeBlanc M, Carrizosa D, Herbst R, Blanke C, Gray J. SWOG S2302, PRAGMATICA-LUNG: A pragmatic trial designed to increase participant representation. Journal Of Clinical Oncology 2025, 43: 11016-11016. DOI: 10.1200/jco.2025.43.16_suppl.11016.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerStandard of careOverall survivalPD-(L)1Randomized phase III trialPhase II randomized studyPlatinum-based therapyTreated with immunotherapyPhase III trialsCell lung cancerYears of ageInhibitor therapyIII trialsStudy drugConcomitant medicationsOS endpointSafety profileToxicity profileAdverse eventsEffective therapyLung cancerBlack patientsReal-world practiceLaboratory assessment
2024
EP.07C.10 Real-World Outcomes of Patients Treated with Neoadjuvant Immunotherapy for Resectable Non-Small Cell Lung Cancer
Ermer T, Kim S, Goldberg S, Zolfaghari E, Blasberg J, Boffa D, Herbst R, Politi K, Schalper K, Dacic S, Woodard G. EP.07C.10 Real-World Outcomes of Patients Treated with Neoadjuvant Immunotherapy for Resectable Non-Small Cell Lung Cancer. Journal Of Thoracic Oncology 2024, 19: s543-s544. DOI: 10.1016/j.jtho.2024.09.1007.Peer-Reviewed Original Research1309P A genomic scar based signature (HRDsig) and biallelic BRCA alterations identify a homologous recombination deficiency (HRD) phenotype of non-small cell lung cancer (NSCLC) potentially actionable to the PARP inhibitor rucaparib: Post-hoc analysis of lung-MAP substudy S1900A
Riess J, Miao J, Wheatley-Price P, Reckamp K, Kozono D, Redman M, Edelman M, Faller B, Villaruz L, Corum L, Gowda A, Srkalovic G, Osarogiagbon R, Baumgart M, Gandara D, Sokol E, Borghaei H, Gray J, Herbst R, Kelly K. 1309P A genomic scar based signature (HRDsig) and biallelic BRCA alterations identify a homologous recombination deficiency (HRD) phenotype of non-small cell lung cancer (NSCLC) potentially actionable to the PARP inhibitor rucaparib: Post-hoc analysis of lung-MAP substudy S1900A. Annals Of Oncology 2024, 35: s832-s833. DOI: 10.1016/j.annonc.2024.08.1366.Peer-Reviewed Original ResearchChitinase 3-like-1 (CHI3L1) in the pathogenesis of epidermal growth factor receptor mutant non-small cell lung cancer
Kamle S, Ma B, Schor G, Bailey M, Pham B, Cho I, Khan H, Azzoli C, Hofstetter M, Sadanaga T, Herbst R, Politi K, Lee C, Elias J. Chitinase 3-like-1 (CHI3L1) in the pathogenesis of epidermal growth factor receptor mutant non-small cell lung cancer. Translational Oncology 2024, 49: 102108. PMID: 39178575, PMCID: PMC11388375, DOI: 10.1016/j.tranon.2024.102108.Peer-Reviewed Original ResearchNon-small cell lung cancerEpidermal growth factor receptorTyrosine kinase inhibitorsEpidermal growth factor receptor mutant non-small cell lung cancerMutant non-small cell lung cancerEpidermal growth factor receptor axisCell lung cancerLung cancerTherapeutic resistanceDownstream targets of EGFRResistance to TKI therapyEpithelial cellsStimulated epidermal growth factor receptorWild type epidermal growth factor receptorTargeting of epidermal growth factor receptorActivating EGFR mutationsChitinase 3-like 1Progression free survivalInduce tumor cell deathEpidermal growth factor receptor activationEffects of EGFR activationInhibited pulmonary metastasisTumor cell deathResponse to treatmentGrowth factor receptorQuantitative Measurement of HER2 Expression in Non–Small Cell Lung Cancer With a High-Sensitivity Assay
Liu M, Vathiotis I, Robbins C, Chan N, Moutafi M, Burela S, Xirou V, Schalper K, Herbst R, Syrigos K, Rimm D. Quantitative Measurement of HER2 Expression in Non–Small Cell Lung Cancer With a High-Sensitivity Assay. Modern Pathology 2024, 37: 100556. PMID: 38964502, PMCID: PMC11416319, DOI: 10.1016/j.modpat.2024.100556.Peer-Reviewed Original ResearchNon-small cell lung cancerCases of non-small cell lung cancerNon-small cell lung cancer casesT-DXdCell lung cancerHER2 expressionBreast cancerRare case of non-small cell lung cancerQuantitative immunofluorescenceAntibody-drug conjugate trastuzumab deruxtecanLung cancerHER2 antibody-drug conjugatesNon-small cell lung cancer patientsDetecting HER2 expressionHER2-targeted therapyMetastatic breast cancerHER2 protein expressionBreast cancer casesHER2 protein levelsAntibody-drug conjugatesProportion of casesTrastuzumab deruxtecanNSCLC casesFrequency of casesImmunohistochemistry scoreUpdated results from COAST, a phase 2 study of durvalumab (D) ± oleclumab (O) or monalizumab (M) in patients (pts) with stage III unresectable non-small cell lung cancer (uNSCLC).
Aggarwal C, Martinez-Marti A, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez A, Dakhil S, Camidge D, Pillet M, Brown M, Dowson A, Cooper Z, Kumar R, Herbst R. Updated results from COAST, a phase 2 study of durvalumab (D) ± oleclumab (O) or monalizumab (M) in patients (pts) with stage III unresectable non-small cell lung cancer (uNSCLC). Journal Of Clinical Oncology 2024, 42: 8046-8046. DOI: 10.1200/jco.2024.42.16_suppl.8046.Peer-Reviewed Original ResearchUnresectable non-small cell lung cancerStage III unresectable non-small cell lung cancerProgression free survivalImmune-mediated AEConcurrent chemoradiotherapyPhase 2 studyNon-small cell lung cancerProlonged progression free survivalECOG PS 0Suppress antitumor immunityMedian follow-upCell lung cancerExpression of CD73Anti-CD73Anti-NKG2AImmunotherapy combinationsAntitumor immunityConsolidation therapyPD-L1Free survivalImmune checkpointsPS 0Open-labelProgressive diseaseDiscontinued treatmentSWOG S2302, PRAGMATICA-LUNG: A prospective randomized study of ramucirumab plus pembrolizumab (PR) versus standard of care (SOC) for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer.
Reckamp K, Redman M, Dragnev K, Iams W, Henick B, Miao J, LeBlanc M, Carrizosa D, Herbst R, Blanke C, Gray J. SWOG S2302, PRAGMATICA-LUNG: A prospective randomized study of ramucirumab plus pembrolizumab (PR) versus standard of care (SOC) for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer. Journal Of Clinical Oncology 2024, 42: tps8657-tps8657. DOI: 10.1200/jco.2024.42.16_suppl.tps8657.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerStandard of careCell lung cancerPD-(L)1Overall survivalAdverse eventsRecurrent non-small cell lung cancerLung cancerTreatment-related adverse eventsRandomized phase II trialStandard of care treatmentPlatinum-based therapyTreated with immunotherapyPhase II trialLog-rank testCompare OSInhibitor therapyII trialCombination therapyStatistically significant improvementTumor resistanceSafety profileTherapeutic optionsRandomized studyLung-MAP S1800D: A phase II/III study of N-803 (ALT-803) plus pembrolizumab versus standard of care in participants with stage IV or recurrent non-small cell lung cancer (NSCLC) previously treated with anti-PD-1 or anti-PD-L1 therapy.
Wrangle J, Redman M, Husain H, Reckamp K, Stinchcombe T, Edelman M, Leal T, Faller B, Minichiello K, Borghaei H, Kelly K, Herbst R, Gray J. Lung-MAP S1800D: A phase II/III study of N-803 (ALT-803) plus pembrolizumab versus standard of care in participants with stage IV or recurrent non-small cell lung cancer (NSCLC) previously treated with anti-PD-1 or anti-PD-L1 therapy. Journal Of Clinical Oncology 2024, 42: 2619-2619. DOI: 10.1200/jco.2024.42.16_suppl.2619.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerProgression-free survivalPhase II/III studiesN-803Overall survivalIL-15Resistance cohortRecurrent non-small cell lung cancerTreated advanced non-small cell lung cancerLung cancerTreated with anti-PD-1Anti-PD-L1 therapyIL-15 receptor alphaAnti-PD-1Anti-PD-L1Performance of immunotherapiesAnti-PD-(L)1Cell lung cancerCancer related deathGamma-chain familyClinical unmet needStandard of careALT-803Secondary endpointsMolecular residual disease (MRD) analysis from the ADAURA trial of adjuvant (adj) osimertinib in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC).
John T, Grohe C, Goldman J, Kato T, Laktionov K, Bonanno L, Tiseo M, Majem M, Domine M, Ahn M, Perol M, Hartmaier R, Robichaux J, Bhetariya P, Markovets A, Rukazenkov Y, Muldoon C, Herbst R, Tsuboi M, Wu Y. Molecular residual disease (MRD) analysis from the ADAURA trial of adjuvant (adj) osimertinib in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2024, 42: 8005-8005. DOI: 10.1200/jco.2024.42.16_suppl.8005.Peer-Reviewed Original ResearchDisease-free survivalMolecular residual diseaseNon-small cell lung cancerDisease-free survival eventsDisease recurrenceEGFR-mutantOverall survivalStage IB-IIIA non-small cell lung cancerEGFR T790M resistance mutationT790M resistance mutationMedian follow-up timeEGFR-TKI sensitivityResected tumor tissueCell lung cancerTumor-specific variantsMedian lead timeWhole-exome sequencingDetection of ctDNAADAURA studyADAURA trialInvestigator-assessedMolecular recurrenceEGFR-TKIsResidual diseaseEligible ptsSummary of Research: Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC
Tsuboi M, Herbst R, John T, Kato T, Majem M, Grohé C, Wang J, Goldman J, Lu S, de Marinis F, Shepherd F, Lee K, Le N, Dechaphunkul A, Kowalski D, Bonanno L, Dómine M, Poole L, Bolanos A, Rukazenkov Y, Wu Y. Summary of Research: Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. Targeted Oncology 2024, 19: 131-134. PMID: 38466534, PMCID: PMC10963460, DOI: 10.1007/s11523-024-01034-3.Peer-Reviewed Original ResearchNon-small cell lung cancerEGFR-mutant non-small cell lung cancerResected EGFR-mutant non-small cell lung cancerEpidermal growth factor receptorOverall survivalEGFR-mutantStage IB-IIIA non-small cell lung cancerPatients treated with osimertinibDisease-free survivalStage II-IIIAEffects of osimertinibCell lung cancerGrowth factor receptorCancer cell deathRisk of deathADAURA studyLength of time patientsOsimertinib groupTumor shrinkagePlacebo groupCancer-freeOsimertinibLung cancerFactor receptorCancer cells
2023
64O Lenvatinib plus pembrolizumab, pemetrexed, and a platinum (len + pembro + chemo) as first-line therapy for metastatic non squamous non-small cell lung cancer (NSCLC): Phase III LEAP-006 study
Herbst R, Cho B, Zhou C, Burotto M, Dols M, Sendur M, Moiseyenko V, Zurawski B, Casarini I, Nishio M, Hui R, Pons-Tostivint E, Dudnik J, Ahmed S, Okpara C, Yin L, Luo Y, Bhagwati N, Abreu D. 64O Lenvatinib plus pembrolizumab, pemetrexed, and a platinum (len + pembro + chemo) as first-line therapy for metastatic non squamous non-small cell lung cancer (NSCLC): Phase III LEAP-006 study. Immuno-Oncology Technology 2023, 20: 100536. DOI: 10.1016/j.iotech.2023.100536.Peer-Reviewed Original ResearchSquamous non-small cell lung cancerNon-small cell lung cancerFirst-line therapyCell lung cancerLung cancerPembrolizumabUnderstanding health-related quality of life measures used in early-stage non-small cell lung cancer clinical trials: A review
Majem M, Basch E, Cella D, Garon E, Herbst R, Leighl N. Understanding health-related quality of life measures used in early-stage non-small cell lung cancer clinical trials: A review. Lung Cancer 2023, 187: 107419. PMID: 38070301, DOI: 10.1016/j.lungcan.2023.107419.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerEarly-stage diseaseHealth-related qualityClinical trialsEarly-stage non-small cell lung cancerTreatment-related adverse effectsAppropriate HRQoL instrumentNSCLC clinical trialsCell lung cancerLong-term treatmentLung cancer clinical trialsCancer clinical researchCancer clinical trialsAdjuvant treatmentAdvanced diseaseHRQOL assessmentTreatment landscapeDisease recurrenceHRQoL instrumentsLung cancerDisease progressionLife measuresHRQoLNarrative reviewHealthcare professionals606 IMpower110: Tertiary lymphoid structures (TLS) and clinical outcomes in advanced non-small cell lung cancer (NSCLC) treated with first-line atezolizumab or chemotherapy
Srivastava M, Gayevskiy V, Ma V, Estay I, Rodas M, Rajendran B, Hoang T, Ballinger M, Amin R, Herbst R, Marinis F, Giaccone G, Jassem J, Spigel D, Schalper K, Koeppen H, Shames D, Johnston R, Giltnane J, Nabet B. 606 IMpower110: Tertiary lymphoid structures (TLS) and clinical outcomes in advanced non-small cell lung cancer (NSCLC) treated with first-line atezolizumab or chemotherapy. 2023, a690-a690. DOI: 10.1136/jitc-2023-sitc2023.0606.Peer-Reviewed Original Research1103 Spatial mapping and clinical significance of the CD39/CD73 adenosinergic pathway as a candidate immunotherapy target in non-small cell lung cancer
Ashley K, Iyer K, Kumar R, Cooper Z, Herbst R, Goldberg S, Schalper K. 1103 Spatial mapping and clinical significance of the CD39/CD73 adenosinergic pathway as a candidate immunotherapy target in non-small cell lung cancer. 2023, a1214-a1214. DOI: 10.1136/jitc-2023-sitc2023.1103.Peer-Reviewed Original ResearchNon-small cell lung cancerCell lung cancerAdenosinergic pathwayLung cancerImmunotherapy targetClinical significanceCancerLBA63 SAPPHIRE: Phase III study of sitravatinib plus nivolumab versus docetaxel in patients with previously treated advanced non-squamous non-small cell lung cancer (NSCLC)
Borghaei H, Johnson M, Garon E, He K, Planchard D, Reck M, Popat S, Herbst R, Leal T, Dumoulin D, de Marinis F, Reynolds C, Theelen W, Percent I, Calderon V, Flandin A, Shazer R, Yan X, Harrigan R, Peters S. LBA63 SAPPHIRE: Phase III study of sitravatinib plus nivolumab versus docetaxel in patients with previously treated advanced non-squamous non-small cell lung cancer (NSCLC). Annals Of Oncology 2023, 34: s1308. DOI: 10.1016/j.annonc.2023.10.064.Peer-Reviewed Original ResearchBiomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results
Gutierrez M, Lam W, Hellmann M, Gubens M, Aggarwal C, Tan D, Felip E, Chiu J, Lee J, Yang J, Garon E, Finocchiaro G, Ahn M, Luft A, Landers G, Basso A, Ma H, Kobie J, Palcza J, Cristescu R, Fong L, Snyder A, Yuan J, Herbst R. Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results. Nature Medicine 2023, 29: 1718-1727. PMID: 37429923, DOI: 10.1038/s41591-023-02385-6.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerObjective response rateAdvanced non-small cell lung cancerCell lung cancerSafety profileCombination therapyLung cancerInvestigator-assessed objective response rateRandomized phase 2 studySolid Tumors version 1.1T-cell-inflamed gene expression profileGroup IIIBiomarker-defined subgroupsFirst-line pembrolizumabPhase 2 studyProgression-free survivalResponse Evaluation CriteriaSubset of patientsHeterogenous tumor microenvironmentData cutoffOverall survivalSecondary outcomesPrimary outcomeTreatment armsTMB assessmentOverall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC).
Herbst R, Tsuboi M, John T, Kato T, Majem M, Grohé C, Wang J, Goldman J, Lu S, Su W, de Marinis F, Shepherd F, Lee K, Le N, Dechaphunkul A, Kowalski D, Poole L, Stachowiak M, Rukazenkov Y, Wu Y. Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2023, 41: lba3-lba3. DOI: 10.1200/jco.2023.41.17_suppl.lba3.Peer-Reviewed Original ResearchNon-small cell lung cancerStage IB-IIIA non-small cell lung cancerAdjuvant osimertinibOverall survival analysisOS HRAdjuvant chemotherapyOS benefitOS ratesII-IIIASurvival analysisDisease-free survival benefitFinal overall survival analysisGlobal phase III studyEGFR T790M resistance mutationII-IIIA diseaseStage IB-IIIAT790M resistance mutationTolerable safety profilePhase III studyCell lung cancerComplete tumor resectionEGFR-TKI sensitizingM resistance mutationExtended treatment durationADAURA study
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