2023
Safety 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 1200
2016
Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study
Hellmann MD, Rizvi NA, Goldman JW, Gettinger SN, Borghaei H, Brahmer JR, Ready NE, Gerber DE, Chow LQ, Juergens RA, Shepherd FA, Laurie SA, Geese WJ, Agrawal S, Young TC, Li X, Antonia SJ. Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study. The Lancet Oncology 2016, 18: 31-41. PMID: 27932067, PMCID: PMC5476941, DOI: 10.1016/s1470-2045(16)30624-6.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCell lung cancerAdverse eventsObjective responseLung cancerGrade 3Treatment-related serious adverse eventsAnti-PD-1 monotherapyChemotherapy-naive NSCLCTolerable safety profileTreatment-related deathsSerious adverse eventsFirst-line therapyFirst-line treatmentPhase 3 studyUS academic centersFirst-line nivolumabWithdrawal of consentFurther clinical developmentHigh response ratePhase 1Bristol-Myers SquibbCombination nivolumabEligible patientsMedian followNivolumab Monotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer
Gettinger S, Rizvi NA, Chow LQ, Borghaei H, Brahmer J, Ready N, Gerber DE, Shepherd FA, Antonia S, Goldman JW, Juergens RA, Laurie SA, Nathan FE, Shen Y, Harbison CT, Hellmann MD. Nivolumab Monotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2016, 34: 2980-2987. PMID: 27354485, PMCID: PMC5569692, DOI: 10.1200/jco.2016.66.9929.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsObjective response ratePD-ligand 1 (PD-L1) expressionAdverse eventsOverall survivalNivolumab monotherapyAdvanced NSCLCLung cancerGrade 3Death-1 immune checkpoint inhibitor antibodyAdvanced non-small cell lung cancerGrade treatment-related adverse eventsNon-small cell lung cancerImmune checkpoint inhibitor antibodyProgression-free survival ratesCheckpoint inhibitor antibodyExploratory end pointsFirst tumor assessmentFirst-line monotherapyOngoing complete responseTolerable safety profileMedian overall survivalGrade 3 rashOnly grade 3Cell lung cancer
2013
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).
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