2017
1344P Brigatinib (BRG) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC): Long-term efficacy and safety results from a phase 1/2 trial
Bazhenova L, Gettinger S, Langer C, Salgia R, Gold K, Rosell R, Shaw A, Weiss G, Haney J, Rivera V, Kerstein D, Camidge R. 1344P Brigatinib (BRG) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC): Long-term efficacy and safety results from a phase 1/2 trial. Annals Of Oncology 2017, 28: v479-v480. DOI: 10.1093/annonc/mdx380.046.Peer-Reviewed Original Research1345P Intracranial efficacy of brigatinib (BRG) in patients (Pts) With crizotinib (CRZ)-refractory anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) and baseline CNS metastases
Ou S, Tiseo M, Camidge R, Ahn M, Huber R, Hochmair M, Kim S, West H, Reckamp K, Molina J, Liu G, Delmonte A, Viteri S, Bearz A, Summers Y, Reichmann W, Kerstein D, Gettinger S, Kim D. 1345P Intracranial efficacy of brigatinib (BRG) in patients (Pts) With crizotinib (CRZ)-refractory anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) and baseline CNS metastases. Annals Of Oncology 2017, 28: v480-v481. DOI: 10.1093/annonc/mdx380.047.Peer-Reviewed Original ResearchDesign of ALTA-1L (ALK in lung cancer trial of brigatinib in first-line), a randomized phase 3 trial of brigatinib (BRG) versus crizotinib (CRZ) in tyrosine kinase inhibitor (TKI)-naive patients (pts) with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Tiseo M, Popat S, Gettinger S, Peters S, Haney J, Kerstein D, Camidge D. Design of ALTA-1L (ALK in lung cancer trial of brigatinib in first-line), a randomized phase 3 trial of brigatinib (BRG) versus crizotinib (CRZ) in tyrosine kinase inhibitor (TKI)-naive patients (pts) with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2017, 35: tps9098-tps9098. DOI: 10.1200/jco.2017.35.15_suppl.tps9098.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalObjective response rateRandomized phase 3 trialPhase 3 trialPrimary endpointTKI therapyPositive non-small cell lung cancerAdvanced anaplastic lymphoma kinaseNext-generation ALK inhibitorsRandomized phase 2 trialPrior TKI therapySafety/tolerabilityPhase 1/2 trialPhase 2 trialKaplan-Meier methodCell lung cancerDuration of responseIndependent review committeeLog-rank testPotent preclinical activityTyrosine kinase inhibitorsAnaplastic lymphoma kinaseNaive patientsNSCLC ptsBrigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase–Positive Non–Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial
Kim DW, Tiseo M, Ahn MJ, Reckamp KL, Hansen KH, Kim SW, Huber RM, West HL, Groen HJM, Hochmair MJ, Leighl NB, Gettinger SN, Langer CJ, Paz-Ares Rodríguez LG, Smit EF, Kim ES, Reichmann W, Haluska FG, Kerstein D, Camidge DR. Brigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase–Positive Non–Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial. Journal Of Clinical Oncology 2017, 35: jco.2016.71.590. PMID: 28475456, DOI: 10.1200/jco.2016.71.5904.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAnaplastic Lymphoma KinaseAntineoplastic AgentsBrain NeoplasmsCarcinoma, Non-Small-Cell LungCoughCrizotinibDiarrheaDisease ProgressionDisease-Free SurvivalFemaleHeadacheHumansLung NeoplasmsMaleMiddle AgedNauseaOrganophosphorus CompoundsProspective StudiesPyrazolesPyridinesPyrimidinesReceptor Protein-Tyrosine KinasesRetreatmentTreatment OutcomeYoung AdultConceptsObjective response rateProgression-free survivalBrain metastasesArm AAdverse eventsLung cancerInvestigator-assessed median progression-free survivalCommon treatment-emergent adverse eventsPositive non-small cell lung cancerNon-small cell lung cancerMedian progression-free survivalMulticenter phase II trialNext-generation ALK inhibitorsTreatment-emergent adverse eventsIntracranial objective response rateBaseline brain metastasesCrizotinib-treated patientsMeasurable brain metastasesPulmonary adverse eventsPrimary end pointPhase II trialCell lung cancerALK-positive NSCLCAnaplastic lymphoma kinase (ALK) geneAnaplastic lymphoma kinase
2016
1207PD Brigatinib (BRG) in patients (Pts) with anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) in a phase 1/2 trial
Bazhenova L, Gettinger S, Langer C, Salgia R, Gold K, Rosell R, Shaw A, Weiss G, Haney J, Rivera V, Haluska F, Kerstein D, Camidge D. 1207PD Brigatinib (BRG) in patients (Pts) with anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) in a phase 1/2 trial. Annals Of Oncology 2016, 27: vi418. DOI: 10.1093/annonc/mdw383.08.Peer-Reviewed Original Research1289TiP ALTA-1L (ALK in lung cancer trial of BrigAtinib in 1st Line): A randomized, phase 3 trial of brigatinib (BRG) versus crizotinib (CRZ) in tyrosine kinase inhibitor (TKI)–naive, advanced anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC)
Popat S, Tiseo M, Gettinger S, Peters S, Haney J, Kerstein D, Camidge D. 1289TiP ALTA-1L (ALK in lung cancer trial of BrigAtinib in 1st Line): A randomized, phase 3 trial of brigatinib (BRG) versus crizotinib (CRZ) in tyrosine kinase inhibitor (TKI)–naive, advanced anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC). Annals Of Oncology 2016, 27: vi448. DOI: 10.1093/annonc/mdw383.89.Peer-Reviewed Original Research1330 Brigatinib efficacy and safety in patients (Pts) with anaplastic lymphoma kinase (ALK)-positive (ALK+) non-small cell lung cancer (NSCLC) in a phase 1/2 trial
Rosell R, Gettinger S, Bazhenova L, Langer C, Salgia R, Shaw A, Narasimhan N, Dorer D, Kerstein D, Camidge D. 1330 Brigatinib efficacy and safety in patients (Pts) with anaplastic lymphoma kinase (ALK)-positive (ALK+) non-small cell lung cancer (NSCLC) in a phase 1/2 trial. Journal Of Thoracic Oncology 2016, 11: s114. DOI: 10.1016/s1556-0864(16)30245-3.Peer-Reviewed Original ResearchCeritinib 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
2015
99O Phase 1/2 Study of Ap26113 in Patients (PTS) with Advanced Malignancies, Including Anaplastic Lymphoma Kinase (ALK)–Positive Non-Small Cell Lung Cancer (NSCLC): Analysis of Safety and Efficacy at Selected Phase 2 Doses
Rosell R, Gettinger S, Bazhenova L, Langer C, Salgia R, Gold K, Shaw A, Dorer D, Kerstein D, Camidge D. 99O Phase 1/2 Study of Ap26113 in Patients (PTS) with Advanced Malignancies, Including Anaplastic Lymphoma Kinase (ALK)–Positive Non-Small Cell Lung Cancer (NSCLC): Analysis of Safety and Efficacy at Selected Phase 2 Doses. Annals Of Oncology 2015, 26: i29. DOI: 10.1093/annonc/mdv050.03.Peer-Reviewed Original Research
2013
First-in-human dose-finding study of the ALK/EGFR inhibitor AP26113 in patients with advanced malignancies: Updated results.
Camidge D, Bazhenova L, Salgia R, Weiss G, Langer C, Shaw A, Narasimhan N, Dorer D, Rivera V, Zhang J, Clackson T, Haluska F, Gettinger S. First-in-human dose-finding study of the ALK/EGFR inhibitor AP26113 in patients with advanced malignancies: Updated results. Journal Of Clinical Oncology 2013, 31: 8031-8031. DOI: 10.1200/jco.2013.31.15_suppl.8031.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsAdverse eventsAdvanced malignanciesCommon grade 3/4 treatment-related adverse eventsGrade 3/4 treatment-related adverse eventsEGFR-TKI resistant NSCLCNon-small cell lung cancerTreatment-related adverse eventsALK tyrosine kinase inhibitorsPhase I/IINovel tyrosine kinase inhibitorEGFR tyrosine kinase inhibitorsDose finding phaseGrade 4 dyspneaTKI-resistant NSCLCPhase II doseFollow-up scanCell lung cancerDose-finding studyAge 60 yrAnaplastic lymphoma kinaseAnti-tumor activityEpidermal growth factor receptorGrowth factor receptorStable disease