Featured Publications
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, Su W, de Marinis F, Shepherd F, Lee K, Le N, Dechaphunkul A, Kowalski D, Poole L, Bolanos A, Rukazenkov Y, Wu Y. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. New England Journal Of Medicine 2023, 389: 137-147. PMID: 37272535, DOI: 10.1056/nejmoa2304594.Peer-Reviewed Original ResearchConceptsDisease-free survivalOverall survivalIIIA diseaseStage IBAdjuvant osimertinibPlacebo groupOsimertinib groupNew serious adverse eventsSignificant overall survival benefitStage IILonger disease-free survivalEnd pointData cutoff datePrevious adjuvant chemotherapyDouble-blind trialOverall survival benefitPrimary end pointSecondary end pointsSerious adverse eventsCell lung cancerCoronavirus disease 2019Epidermal growth factor receptorADAURA trialAdjuvant chemotherapyEligible patientsThe end of the beginning: progress and next steps in KRAS-mutant non-small-cell lung cancer
Goldberg S, Herbst R. The end of the beginning: progress and next steps in KRAS-mutant non-small-cell lung cancer. The Lancet 2023, 401: 706-707. PMID: 36774937, DOI: 10.1016/s0140-6736(23)00288-x.Peer-Reviewed Original ResearchFuture Directions in the Management of Non-Small Cell Lung Cancer Harboring Driver Mutations.
Herbst RS. Future Directions in the Management of Non-Small Cell Lung Cancer Harboring Driver Mutations. Oncology 2022, 36: 562-563. PMID: 36107783, DOI: 10.46883/2022.25920974.Peer-Reviewed Original Research
2025
Effects of oral nicotine pouches on cigarette smoking behaviour and tobacco harm exposure: a randomised pilot trial in adults
Fucito L, Baldassarri S, Wu R, Gueorguieva R, Morean M, Herbst R, Krishnan-Sarin S, O’Malley S. Effects of oral nicotine pouches on cigarette smoking behaviour and tobacco harm exposure: a randomised pilot trial in adults. Tobacco Control 2025, tc-2024-059094. PMID: 40550628, DOI: 10.1136/tc-2024-059094.Peer-Reviewed Original ResearchSmoking abstinenceOral nicotine pouchesSmoking behaviorNicotine pouchesRandomised pilot trialPoint prevalence smoking abstinenceComplete smoking abstinenceOutpatient research clinicCigarette smoking behaviorPreliminary supportTobacco-specific carcinogenNon-significantNicotineResearch clinicOpen-labelSmoking cessationAbstinenceCigarette substituteUrinary levelsWeek 4Nicotine strengthSmoking cigarettesParticipantsCompare groupsAdultsElevated 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 assessmentLurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial.
Paz-Ares L, Borghaei H, Liu S, Peters S, Herbst R, Stencel K, Majem M, CzyĹĽewicz G, Bernabe Caro R, Lee K, Johnson M, Karadurmus N, Grohe C, Cuchelkar V, Graupner V, Kaul M, Lin Y, Chakrabarti D, Bhatt K, Reck M. Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial. Journal Of Clinical Oncology 2025, 43: 8006-8006. DOI: 10.1200/jco.2025.43.16_suppl.8006.Peer-Reviewed Original ResearchExtensive-stage small cell lung cancerReceipt of prophylactic cranial irradiationGlobal phase 3 studySmall cell lung cancerProphylactic cranial irradiationPlatinum-based chemotherapySignificant OS benefitPhase 3 studyCell lung cancerClinically meaningful benefitLong-term survivalMaintenance phaseStratified log-rankPD-(L)1RECIST v1.1ECOG PSOS benefitOS improvementCranial irradiationLiver metastasesOpen-labelEligible ptsAggressive diseaseFirst-linePrimary endpointS1900E: A phase II study examining impact of co-mutations on sotorasib for previously treated stage IV/recurrent KRAS G12C mutated (MUT) non-squamous (Non-sq) non-small cell lung cancer (NSCLC) (ECOG-ACRIN led Lung-MAP Sub-study).
Padda S, Redman M, Gerber D, Minichiello K, Mehta D, Mashru S, Hakim H, Brahmer J, Bradley J, Stinchcombe T, Gray J, Kelly K, Kozono D, Reckamp K, Edelman M, Borghaei H, Patel J, Herbst R, Ramalingam S, Neal J. S1900E: A phase II study examining impact of co-mutations on sotorasib for previously treated stage IV/recurrent KRAS G12C mutated (MUT) non-squamous (Non-sq) non-small cell lung cancer (NSCLC) (ECOG-ACRIN led Lung-MAP Sub-study). Journal Of Clinical Oncology 2025, 43: 8518-8518. DOI: 10.1200/jco.2025.43.16_suppl.8518.Peer-Reviewed Original ResearchDisease control rateProgression-free survivalDuration of responseCo-mutationsOverall survivalECOG PS 0-1Impact of co-mutationsInvestigate progression-free survivalEfficacy of sotorasibNon-sq NSCLCTP53 co-mutationsPD-L1 expressionPhase II studyAdverse event ratesTumor suppressor genePD-(L)1PD-L1Platinum chemotherapySystemic therapyCtDNA analysisII studyPrimary endpointGrade 3Resistance patternsControl rateLenvatinib Plus Pembrolizumab, Pemetrexed, and a Platinum as First-Line Therapy for Metastatic Nonsquamous Non–Small-Cell Lung Cancer: Phase 3 LEAP-006 Study
Herbst R, Cho B, Zhou C, Burotto M, Dols M, Sendur M, Moiseyenko V, Casarini I, Nishio M, Hui R, Pons-Tostivint E, Dudnik J, Ahmed S, Okpara C, Dutcus C, Yin L, Luo Y, Chirovsky D, Bhagwati N, Abreu D. Lenvatinib Plus Pembrolizumab, Pemetrexed, and a Platinum as First-Line Therapy for Metastatic Nonsquamous Non–Small-Cell Lung Cancer: Phase 3 LEAP-006 Study. Journal Of Thoracic Oncology 2025 PMID: 40419140, DOI: 10.1016/j.jtho.2025.05.016.Peer-Reviewed Original ResearchNonsquamous non-small-cell lung cancerProgression-free survivalMetastatic nonsquamous non-small-cell lung cancerNonsquamous NSCLCNon-small-cell lung cancerFirst-line pembrolizumabOverall survivalTargetable genetic alterationsPlacebo armGenetic alterationsLung cancerTreatment-related adverse eventsFirst-line therapyMedian follow-upDouble-blind studyPrimary endpointPembrolizumabLenvatinibAdverse eventsChemotherapyFollow-upDisease progressionSafety signalsPemetrexedMonthsThe evolving immuno-angiogenic paradigm in NSCLC: lessons from ivonescimab
Herbst R, Chen L. The evolving immuno-angiogenic paradigm in NSCLC: lessons from ivonescimab. Nature Reviews Clinical Oncology 2025, 22: 461-462. PMID: 40329050, DOI: 10.1038/s41571-025-01024-y.Peer-Reviewed Original ResearchAdvanced-stage non-small-cell lung cancerNon-small-cell lung cancerProgression-free survivalOverall survival resultsAntitumour immunityReverse immunosuppressionTumor vasculatureVEGF antibodySurvival resultsLung cancerPembrolizumabNSCLCImmunosuppressionTumorPatientsCancerVasculatureDiverse populationsMolecular residual disease analysis of adjuvant osimertinib in resected EGFR-mutated stage IB–IIIA non-small-cell lung cancer
Herbst R, John T, Grohé C, Goldman J, Kato T, Laktionov K, Bonanno L, Tiseo M, Majem M, Dómine M, Ahn M, Kowalski D, Pérol M, Sriuranpong V, Özgüroğlu M, Bhetariya P, Markovets A, Rukazenkov Y, Muldoon C, Robichaux J, Hartmaier R, Tsuboi M, Wu Y. Molecular residual disease analysis of adjuvant osimertinib in resected EGFR-mutated stage IB–IIIA non-small-cell lung cancer. Nature Medicine 2025, 31: 1958-1968. PMID: 40097663, PMCID: PMC12176615, DOI: 10.1038/s41591-025-03577-y.Peer-Reviewed Original ResearchConceptsMolecular residual diseaseDisease-free survivalNon-small-cell lung cancerDisease-free survival eventsEvent-free rateAdjuvant osimertinibOsimertinib treatmentStage IB-IIIA non-small-cell lung cancerLung cancerOverall survival improvementEvent-free statusPosttreatment follow-upExploratory post hoc analysisYear adjuvant treatmentPost hoc analysisDFS eventsOsimertinib groupResidual diseaseTreatment discontinuationPlacebo groupAdjuvant therapyAdjuvant treatmentSurvival improvementOsimertinibFollow-upAuthor Correction: CTLA4 blockade abrogates KEAP1/STK11-related resistance to PD-(L)1 inhibitors
Skoulidis F, Araujo H, Do M, Qian Y, Sun X, Cobo A, Le J, Montesion M, Palmer R, Jahchan N, Juan J, Min C, Yu Y, Pan X, Arbour K, Vokes N, Schmidt S, Molkentine D, Owen D, Memmott R, Patil P, Marmarelis M, Awad M, Murray J, Hellyer J, Gainor J, Dimou A, Bestvina C, Shu C, Riess J, Blakely C, Pecot C, Mezquita L, Tabbó F, Scheffler M, Digumarthy S, Mooradian M, Sacher A, Lau S, Saltos A, Rotow J, Johnson R, Liu C, Stewart T, Goldberg S, Killam J, Walther Z, Schalper K, Davies K, Woodcock M, Anagnostou V, Marrone K, Forde P, Ricciuti B, Venkatraman D, Van Allen E, Cummings A, Goldman J, Shaish H, Kier M, Katz S, Aggarwal C, Ni Y, Azok J, Segal J, Ritterhouse L, Neal J, Lacroix L, Elamin Y, Negrao M, Le X, Lam V, Lewis W, Kemp H, Carter B, Roth J, Swisher S, Lee R, Zhou T, Poteete A, Kong Y, Takehara T, Paula A, Parra Cuentas E, Behrens C, Wistuba I, Zhang J, Blumenschein G, Gay C, Byers L, Gibbons D, Tsao A, Lee J, Bivona T, Camidge D, Gray J, Leighl N, Levy B, Brahmer J, Garassino M, Gandara D, Garon E, Rizvi N, Scagliotti G, Wolf J, Planchard D, Besse B, Herbst R, Wakelee H, Pennell N, Shaw A, Jänne P, Carbone D, Hellmann M, Rudin C, Albacker L, Mann H, Zhu Z, Lai Z, Stewart R, Peters S, Johnson M, Wong K, Huang A, Winslow M, Rosen M, Winters I, Papadimitrakopoulou V, Cascone T, Jewsbury P, Heymach J. Author Correction: CTLA4 blockade abrogates KEAP1/STK11-related resistance to PD-(L)1 inhibitors. Nature 2025, 639: e19-e19. PMID: 40016449, PMCID: PMC11903295, DOI: 10.1038/s41586-025-08767-9.Peer-Reviewed Original Research
2024
Optimizing public-private partnerships to support clinical cancer research
Herbst R, Blumenthal G, Khleif S, Lippman S, Meropol N, Rosati K, Shulman L, Smith H, Wang M, Winn R, Schilsky R. Optimizing public-private partnerships to support clinical cancer research. Journal Of The National Cancer Institute 2024, djae279. PMID: 39666955, DOI: 10.1093/jnci/djae279.Peer-Reviewed Original ResearchClinical cancer researchNational Cancer Policy ForumPublic-private partnershipEquitable care deliveryCancer researchCare deliveryEfficient drug developmentImplementation of public-private partnershipPromote collaborationTherapeutic innovationsClinical applicationPartnershipPolicy forumsDrug developmentNonprofit organizationsCTLA4 blockade abrogates KEAP1/STK11-related resistance to PD-(L)1 inhibitors
Skoulidis F, Araujo H, Do M, Qian Y, Sun X, Cobo A, Le J, Montesion M, Palmer R, Jahchan N, Juan J, Min C, Yu Y, Pan X, Arbour K, Vokes N, Schmidt S, Molkentine D, Owen D, Memmott R, Patil P, Marmarelis M, Awad M, Murray J, Hellyer J, Gainor J, Dimou A, Bestvina C, Shu C, Riess J, Blakely C, Pecot C, Mezquita L, Tabbó F, Scheffler M, Digumarthy S, Mooradian M, Sacher A, Lau S, Saltos A, Rotow J, Johnson R, Liu C, Stewart T, Goldberg S, Killam J, Walther Z, Schalper K, Davies K, Woodcock M, Anagnostou V, Marrone K, Forde P, Ricciuti B, Venkatraman D, Van Allen E, Cummings A, Goldman J, Shaish H, Kier M, Katz S, Aggarwal C, Ni Y, Azok J, Segal J, Ritterhouse L, Neal J, Lacroix L, Elamin Y, Negrao M, Le X, Lam V, Lewis W, Kemp H, Carter B, Roth J, Swisher S, Lee R, Zhou T, Poteete A, Kong Y, Takehara T, Paula A, Parra Cuentas E, Behrens C, Wistuba I, Zhang J, Blumenschein G, Gay C, Byers L, Gibbons D, Tsao A, Lee J, Bivona T, Camidge D, Gray J, Leighl N, Levy B, Brahmer J, Garassino M, Gandara D, Garon E, Rizvi N, Scagliotti G, Wolf J, Planchard D, Besse B, Herbst R, Wakelee H, Pennell N, Shaw A, Jänne P, Carbone D, Hellmann M, Rudin C, Albacker L, Mann H, Zhu Z, Lai Z, Stewart R, Peters S, Johnson M, Wong K, Huang A, Winslow M, Rosen M, Winters I, Papadimitrakopoulou V, Cascone T, Jewsbury P, Heymach J. CTLA4 blockade abrogates KEAP1/STK11-related resistance to PD-(L)1 inhibitors. Nature 2024, 635: 462-471. PMID: 39385035, PMCID: PMC11560846, DOI: 10.1038/s41586-024-07943-7.Peer-Reviewed Original ResearchNon-small-cell lung cancerImmune checkpoint blockadeTumor suppressor genePD-L1Advanced non-small-cell lung cancerCD8+ cytotoxic T cellsSuppressor geneCD4+ effector cellsDual immune checkpoint blockadeMouse modelPD-L1 inhibitor durvalumabSuppressive myeloid cellsPD-L1 inhibitorsImmune-related toxicitiesPD-(L)1 inhibitorsAnti-tumor efficacyCytotoxic T cellsMyeloid cell compartmentAdverse tumor microenvironmentAssociated with higher ratesAnti-tumor activityLoss of Keap1CTLA4 inhibitorsSTK11 alterationsCheckpoint blockadeEP.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 receptorLung-MAP Next-Generation Sequencing Analysis of Advanced Squamous Cell Lung Cancers (SWOG S1400)
Kozono D, Hua X, Wu M, Tolba K, Waqar S, Dragnev K, Cheng H, Hirsch F, Mack P, Gray J, Kelly K, Borghaei H, Herbst R, Gandara D, Redman M. Lung-MAP Next-Generation Sequencing Analysis of Advanced Squamous Cell Lung Cancers (SWOG S1400). Journal Of Thoracic Oncology 2024, 19: 1618-1629. PMID: 39111731, PMCID: PMC11625613, DOI: 10.1016/j.jtho.2024.07.024.Peer-Reviewed Original ResearchNext generation sequencingLung SqCCNext generation sequencing dataAdvanced squamous cell lung cancerGene set analysisSquamous cell lung cancerAssociated with poor survivalFalse discovery rate <Squamous cell cancerCancer-related genesCell lung cancerCox proportional hazards modelsOxidative stress responseNGS datasetsUncharacterized genesLung cancer subtypesNon-overlapping setsCancer Genome AtlasProportional hazards modelGeneration sequencingGenetic variantsUncharacterized roleCell cancerTreatment resistanceGene alterations
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