2021
Brigatinib Versus Crizotinib in ALK Inhibitor–Naive Advanced ALK-Positive NSCLC: Final Results of Phase 3 ALTA-1L Trial
Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, Garcia Campelo MR, Kim DW, Griesinger F, Felip E, Califano R, Spira AI, Gettinger SN, Tiseo M, Lin HM, Liu Y, Vranceanu F, Niu H, Zhang P, Popat S. Brigatinib Versus Crizotinib in ALK Inhibitor–Naive Advanced ALK-Positive NSCLC: Final Results of Phase 3 ALTA-1L Trial. Journal Of Thoracic Oncology 2021, 16: 2091-2108. PMID: 34537440, DOI: 10.1016/j.jtho.2021.07.035.Peer-Reviewed Original ResearchConceptsBlinded independent review committeeIndependent review committeeBrain metastasesSurvival benefitSuperior efficacyTP53 mutationsAdvanced ALK-positive NSCLCBaseline brain metastasesSecondary ALK mutationsMedian overall survivalOverall survival benefitPrimary end pointNew safety signalsPhase 3 studyALK-positive NSCLCLung cancer trialsPlasma cell-free DNAPoor prognostic biomarkerReview CommitteeEML4-ALK variantsCell-free DNAAdvanced ALKOverall survivalPoor PFSPositive NSCLC
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 follow
2015
Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer
Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhäufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crinò L, Blumenschein GR, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer. New England Journal Of Medicine 2015, 373: 1627-1639. PMID: 26412456, PMCID: PMC5705936, DOI: 10.1056/nejmoa1507643.Peer-Reviewed Original ResearchConceptsProgression-free survivalOverall survival rateOverall survivalNivolumab groupDocetaxel groupLung cancerAdvanced nonsquamous non-small cell lung cancerNonsquamous non-small cell lung cancerSurvival rateNon-small cell lung cancerInternational phase 3 studyPD-1-mediated signalingPlatinum-based doublet chemotherapyTreatment-related adverse eventsEnd pointAdvanced nonsquamous NSCLCMedian overall survivalPrimary end pointPD-1 ligandsPhase 3 studyPlatinum-based chemotherapyCell lung cancerBody surface areaDoublet chemotherapyNonsquamous NSCLC