2022
Long-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials
Gettinger SN, Huber RM, Kim DW, Bazhenova L, Hansen KH, Tiseo M, Langer CJ, Rodríguez L, West HL, Reckamp KL, Weiss GJ, Smit EF, Hochmair MJ, Kim SW, Ahn MJ, Kim ES, Groen HJM, Pye J, Liu Y, Zhang P, Vranceanu F, Camidge DR. Long-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials. JTO Clinical And Research Reports 2022, 3: 100385. PMID: 36065449, PMCID: PMC9440305, DOI: 10.1016/j.jtocrr.2022.100385.Peer-Reviewed Original ResearchProgression-free survivalPhase 1/2 studyMedian investigator-assessed progression-free survivalInvestigator-assessed progression-free survivalMedian overall survivalPhase 2 trialLong-term efficacyOverall survivalPhase 1/2Arm AStudy endMedian intracranial progression-free survivalIntracranial progression-free survivalRandomized phase 2 trialNew safety signalsIndependent review committeeArm B.Advanced malignanciesBrain metastasesManageable safetyArm BPositive NSCLCSafety signalsNSCLCPatients
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 NSCLCBrigatinib (BRG) in ALK+ crizotinib (CRZ)-refractory non-small cell lung cancer (NSCLC): Final results of the phase 1/2 and phase 2 (ALTA) trials.
Gettinger S, Huber R, Kim D, Bazhenova L, Hansen K, Tiseo M, Langer C, Paz-Ares L, West H, Reckamp K, Weiss G, Smit E, Hochmair M, Kim S, Ahn M, Kim E, Groen H, Pye J, Vranceanu F, Camidge D. Brigatinib (BRG) in ALK+ crizotinib (CRZ)-refractory non-small cell lung cancer (NSCLC): Final results of the phase 1/2 and phase 2 (ALTA) trials. Journal Of Clinical Oncology 2021, 39: 9071-9071. DOI: 10.1200/jco.2021.39.15_suppl.9071.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalPhase 1/2 studyIndependent review committeeArm A/BPhase 2 trialOverall survivalPhase 1/2Arm AKaplan-MeierRefractory non-small cell lung cancerMetastatic non-small cell lung cancerHigher median progression-free survivalMedian progression-free survivalTreatment-emergent adverse eventsALK tyrosine kinase inhibitorsKinase inhibitorsBaseline brain metastasesObjective response rateOpen-label trialNew safety signalsCell lung cancerDuration of responseTreatment of patientsLong-term efficacySecond-line nivolumab in relapsed small-cell lung cancer: CheckMate 331☆
Spigel D, Vicente D, Ciuleanu T, Gettinger S, Peters S, Horn L, Audigier-Valette C, Aranda N, Juan-Vidal O, Cheng Y, Zhang H, Shi M, Luft A, Wolf J, Antonia S, Nakagawa K, Fairchild J, Baudelet C, Pandya D, Doshi P, Chang H, Reck M. Second-line nivolumab in relapsed small-cell lung cancer: CheckMate 331☆. Annals Of Oncology 2021, 32: 631-641. PMID: 33539946, DOI: 10.1016/j.annonc.2021.01.071.Peer-Reviewed Original ResearchConceptsSmall cell lung cancerRelapsed Small-Cell Lung CancerOverall survivalLung cancerMedian progression-free survivalTreatment-related adverse eventsBaseline lactate dehydrogenaseBaseline liver metastasesSecond-line nivolumabSelect baseline characteristicsTrials of nivolumabImproved overall survivalObjective response rateCombined positive scoreNew safety signalsProgression-free survivalPlatinum-based chemotherapyPrimary endpointAdverse eventsBaseline characteristicsLiver metastasesMedian durationStandard chemotherapySurvival benefitUnacceptable toxicityFive-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer
Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2021, 39: 723-733. PMID: 33449799, PMCID: PMC8078445, DOI: 10.1200/jco.20.01605.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungClinical Trials, Phase III as TopicDisease ProgressionDocetaxelFemaleHumansImmune Checkpoint InhibitorsImmunotherapyLung NeoplasmsMaleMiddle AgedNivolumabProgression-Free SurvivalRandomized Controlled Trials as TopicTime FactorsTubulin ModulatorsYoung AdultConceptsTreatment-related adverse eventsNivolumab-treated patientsProgression-free survivalPhase III trialsOverall survivalCheckMate 017Advanced NSCLCIII trialsOS ratesLung cancerGrade 4 treatment-related adverse eventsFirst-line platinum-based chemotherapyNon-small cell lung cancerRandomized phase III trialEnd pointDeath-1 inhibitorsDocetaxel-treated patientsExploratory landmark analysisPrimary end pointSecondary end pointsFive-year outcomesNew safety signalsPlatinum-based chemotherapyCell lung cancerECOG PS
2019
Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis
Antonia SJ, Borghaei H, Ramalingam SS, Horn L, De Castro Carpeño J, Pluzanski A, Burgio MA, Garassino M, Chow LQM, Gettinger S, Crinò L, Planchard D, Butts C, Drilon A, Wojcik-Tomaszewska J, Otterson GA, Agrawal S, Li A, Penrod JR, Brahmer J. Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis. The Lancet Oncology 2019, 20: 1395-1408. PMID: 31422028, PMCID: PMC7193685, DOI: 10.1016/s1470-2045(19)30407-3.Peer-Reviewed Original ResearchConceptsPD-L1 expressionCell lung cancerOverall survivalCheckMate 017Progressive diseaseHazard ratioSurvival outcomesLung cancerLong-term survival advantageDose of nivolumabTrials of nivolumabNew safety signalsFour-year survivalLonger overall survivalLonger response durationBristol-Myers SquibbStable diseaseAdvanced NSCLCObjective responsePooled analysisLong-term benefitsNivolumabSafety signalsClinical dataClinical studies