2018
Brigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer
Camidge DR, Kim HR, Ahn MJ, Yang JC, Han JY, Lee JS, Hochmair MJ, Li JY, Chang GC, Lee KH, Gridelli C, Delmonte A, Garcia Campelo R, Kim DW, Bearz A, Griesinger F, Morabito A, Felip E, Califano R, Ghosh S, Spira A, Gettinger SN, Tiseo M, Gupta N, Haney J, Kerstein D, Popat S. Brigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer. New England Journal Of Medicine 2018, 379: 2027-2039. PMID: 30280657, DOI: 10.1056/nejmoa1810171.Peer-Reviewed Original ResearchConceptsProgression-free survivalALK-positive NSCLCAdvanced ALK-positive NSCLCObjective response rateFirst interim analysisALK inhibitorsLung cancerIntracranial responseInterim analysisNext-generation anaplastic lymphoma kinase (ALK) inhibitorResponse rateConfirmed objective response rateEnd pointSmall cell lung cancerBlinded independent central reviewAnaplastic lymphoma kinase inhibitorsEfficacy of brigatinibPrimary end pointSecondary end pointsPhase 3 trialALK-Positive NonCell lung cancerIndependent central reviewNew safety concernsCrizotinib group
2017
Activity of brigatinib (BRG) in crizotinib (CRZ)-resistant ALK+ NSCLC patients (pts) according to ALK plasma mutation status.
Bazhenova L, Hodgson J, Langer C, Simon G, Gettinger S, Ou S, Reckamp K, West H, Chiappori A, Koh H, Molina J, Shaw A, Patel J, Favaro J, Haney J, Reichmann W, Kerstein D, Rivera V, Camidge D. Activity of brigatinib (BRG) in crizotinib (CRZ)-resistant ALK+ NSCLC patients (pts) according to ALK plasma mutation status. Journal Of Clinical Oncology 2017, 35: 9065-9065. DOI: 10.1200/jco.2017.35.15_suppl.9065.Peer-Reviewed Original ResearchSecondary ALK mutationsNSCLC ptsALK mutationsALK fusionMutation statusObjective response ratePlasma samplesALK mutation statusSelective ALK inhibitorNSCLC patientsClinical activityEvaluable samplesALK inhibitorsResistance patternsSecondary resistanceTherapeutic implicationsComplex mutation patternsResponse rateBrigatinibPlasma specimensWild-type ALKALKTrialsGood responseMutation patternsBrigatinib (BRG) in patients (pts) with crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC) and brain metastases in the pivotal randomized phase 2 ALTA trial.
Ou S, Tiseo M, Camidge D, Ahn M, Huber R, Hochmair M, Kim S, West H, Reckamp K, Molina J, Liu G, Delmonte A, Viteri Ramirez S, Bearz A, Summers Y, Reichmann W, Kerstein D, Gettinger S, Kim D. Brigatinib (BRG) in patients (pts) with crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC) and brain metastases in the pivotal randomized phase 2 ALTA trial. Journal Of Clinical Oncology 2017, 35: e20502-e20502. DOI: 10.1200/jco.2017.35.15_suppl.e20502.Peer-Reviewed Original ResearchNon-small cell lung cancerBaseline brain metastasesBrain metastasesIndependent review committeeIntracranial efficacyCommon treatment-emergent adverse eventsNext-generation ALK inhibitorsTreatment-emergent adverse eventsFirst disease progressionCell lung cancerBlood CPKNSCLC ptsAdverse eventsAcceptable safetyLung cancerDisease progressionIntracranial responseALK inhibitorsBrigatinibMetastasisReview CommitteeGood responseEfficacyTrialsHypertension
2016
Activity and safety of brigatinib in ALK-rearranged non-small-cell lung cancer and other malignancies: a single-arm, open-label, phase 1/2 trial
Gettinger SN, Bazhenova LA, Langer CJ, Salgia R, Gold KA, Rosell R, Shaw AT, Weiss GJ, Tugnait M, Narasimhan NI, Dorer DJ, Kerstein D, Rivera VM, Clackson T, Haluska FG, Camidge DR. Activity and safety of brigatinib in ALK-rearranged non-small-cell lung cancer and other malignancies: a single-arm, open-label, phase 1/2 trial. The Lancet Oncology 2016, 17: 1683-1696. PMID: 27836716, DOI: 10.1016/s1470-2045(16)30392-8.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsPhase 2 doseCell lung cancerObjective responsePrimary endpointAdvanced malignanciesAdverse eventsLung cancerGrade 3ALK inhibitorsPrevious EGFR-tyrosine kinase inhibitorsSerious treatment-emergent adverse eventsCohort 5Phase 2 primary endpointRandomised phase 2 trialPotential new treatment optionAnaplastic lymphoma kinase (ALK) gene rearrangementEGFR tyrosine kinase inhibitorsCommon grade 3Acceptable safety profilePhase 2 trialProportion of patientsTotal daily dosesPotent preclinical activityNew treatment optionsCeritinib enables stereotactic radiosurgery to a previously untreatable symptomatic brain metastasis in a patient with ALK rearranged non-small cell lung cancer
Qian J, Yu J, Gettinger S, Chiang V. Ceritinib enables stereotactic radiosurgery to a previously untreatable symptomatic brain metastasis in a patient with ALK rearranged non-small cell lung cancer. Cancer Treatment And Research Communications 2016, 6: 17-19. DOI: 10.1016/j.ctrc.2016.02.002.Peer-Reviewed Original ResearchNon-small cell lung cancerAnaplastic lymphoma kinaseWhole-brain radiation therapySymptomatic brain metastasesBrain radiation therapyCell lung cancerBrain metastasesStereotactic radiosurgerySystemic therapyLung cancerRadiation therapyActive small-molecule tyrosine kinase inhibitorLarge symptomatic brain metastasisNext-generation ALK inhibitorsSmall molecule tyrosine kinase inhibitorsYear old Caucasian femaleMolecule tyrosine kinase inhibitorsGeneration ALK inhibitorsALK inhibitor crizotinibOld Caucasian femaleKey driver mutationsTyrosine kinase inhibitorsLocal therapyInhibitor crizotinibALK inhibitors
2014
Perfect ALKemy: Optimizing the Use of ALK-Directed Therapies in Lung Cancer
Politi K, Gettinger S. Perfect ALKemy: Optimizing the Use of ALK-Directed Therapies in Lung Cancer. Clinical Cancer Research 2014, 20: 5576-5578. PMID: 25228532, PMCID: PMC4401422, DOI: 10.1158/1078-0432.ccr-14-2306.Commentaries, Editorials and Letters