2025
ORCHARD: Osimertinib Plus Necitumumab in Patients With Epidermal Growth Factor Receptor–Mutated Advanced Non–Small Cell Lung Cancer With a Secondary Epidermal Growth Factor Receptor Alteration Whose Disease Had Progressed on First-Line Osimertinib
Riess J, de Langen A, Ponce S, Goldberg S, Piotrowska Z, Goldman J, Le X, Cho B, Yoneshima Y, Ambrose H, Cavazzina R, Tang K, Lau J, Yu H. ORCHARD: Osimertinib Plus Necitumumab in Patients With Epidermal Growth Factor Receptor–Mutated Advanced Non–Small Cell Lung Cancer With a Secondary Epidermal Growth Factor Receptor Alteration Whose Disease Had Progressed on First-Line Osimertinib. JCO Precision Oncology 2025, 9: e2400818. PMID: 40466026, DOI: 10.1200/po-24-00818.Peer-Reviewed Original ResearchConceptsAdvanced non-small cell lung cancerNon-small cell lung cancerCell lung cancerLung cancerEpidermal growth factor receptor alterationsFirst-line osimertinibSafety of osimertinibProgression-free survivalDuration of responseNovel drug combinationsData cutoffPartial responseOsimertinib resistanceRisk-benefit analysisOverall survivalReceptor alterationsDiscontinued treatmentInvestigator assessmentClinical benefitNecitumumabSafety profileOsimertinibReport final resultsAdverse eventsDrug combinations
2020
Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer
Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer. New England Journal Of Medicine 2020, 383: 1711-1723. PMID: 32955177, DOI: 10.1056/nejmoa2027071.Peer-Reviewed Original ResearchMeSH KeywordsAcrylamidesAdultAgedAged, 80 and overAniline CompoundsAntineoplastic AgentsCarcinoma, Non-Small-Cell LungChemotherapy, AdjuvantDisease-Free SurvivalDouble-Blind MethodErbB ReceptorsFemaleHumansLung NeoplasmsLymphatic MetastasisMaleMiddle AgedMutationNeoplasm Recurrence, LocalNeoplasm StagingPneumonectomyProtein Kinase InhibitorsConceptsDisease-free survivalMutation-positive NSCLCIIIA diseasePlacebo groupOsimertinib groupStage IBLung cancerUntreated epidermal growth factor receptorNon-small cell lung cancerOverall populationStage IIEnd pointCentral nervous system diseaseSafety of osimertinibPrimary end pointSecondary end pointsPhase 3 trialOverall survival dataCell lung cancerNew safety concernsNervous system diseasesEpidermal growth factor receptorGrowth factor receptorAdjuvant therapyOverall survivalOsimertinib as adjuvant therapy in patients (pts) with stage IB–IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA.
Herbst R, Tsuboi M, John T, Grohé C, Majem M, Goldman J, Kim S, Marmol D, Rukazenkov Y, Wu Y. Osimertinib as adjuvant therapy in patients (pts) with stage IB–IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA. Journal Of Clinical Oncology 2020, 38: lba5-lba5. DOI: 10.1200/jco.2020.38.18_suppl.lba5.Peer-Reviewed Original ResearchDisease-free survivalComplete tumor resectionDFS hazard ratioAdjuvant chemotherapyData cutoffHazard ratioOverall survivalTumor resectionAdjuvant osimertinibDFS ratesEGFRm NSCLCEGFR-TKISafety profileEGFR mutation-positive NSCLCEffective new treatment strategyResected stage IISafety of osimertinibEarly-stage diseaseMutation-positive NSCLCNew treatment strategiesUnplanned interim analysisEligible ptsIIIA NSCLCNSCLC presentPS 0/1
2019
1450P Frequency of epidermal growth factor receptor (EGFR) mutations in stage IB–IIIA EGFR mutation positive non-small cell lung cancer (NSCLC) after complete tumour resection
Tsuboi M, Herbst R, John T, Grohe C, Majem M, Goldman J, Kim S, Yu C, Miziara J, Novello S, Urban D, Akewanlop C, Öztürk A, Quang B, Kowalski D, Marmol D, Marotti M, Laus G, Wu Y. 1450P Frequency of epidermal growth factor receptor (EGFR) mutations in stage IB–IIIA EGFR mutation positive non-small cell lung cancer (NSCLC) after complete tumour resection. Annals Of Oncology 2019, 30: v589. DOI: 10.1093/annonc/mdz258.010.Peer-Reviewed Original ResearchNon-small cell lung cancerBristol-Myers SquibbComplete tumor resectionEGFR mutationsBoehringer IngelheimMerck SharpAdjuvant therapyComplete resectionTumor resectionStage IB-IIIA non-small cell lung cancerEGFRm non-small cell lung cancerMutation-positive non-small cell lung cancerEarly-stage non-small cell lung cancerEGFR mutation-positive non-small cell lung cancerEli LillyOral EGFR tyrosine kinase inhibitorPositive non-small cell lung cancerT790MEpidermal growth factor receptor (EGFR) mutationsEGFR T790M mutationEGFR tyrosine kinase inhibitorsGenentech/RocheNon-squamous histologySafety of osimertinibPlacebo-controlled study
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