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
2017
Brigatinib (BRG) in patients (pts) with ALK+ non-small cell lung cancer (NSCLC): Updates 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 D. Brigatinib (BRG) in patients (pts) with ALK+ non-small cell lung cancer (NSCLC): Updates from a phase 1/2 trial. Journal Of Clinical Oncology 2017, 35: e20682-e20682. DOI: 10.1200/jco.2017.35.15_suppl.e20682.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalTreatment-emergent adverse eventsBaseline brain metastasesNSCLC ptsPhase 1/2 trialAdverse eventsBrain metastasesObjective responseSerious treatment-emergent adverse eventsMedian intracranial progression-free survivalIntracranial progression-free survivalRandomized phase 2 trialIntracranial objective responseMedian overall survivalMedian treatment durationPhase 2 trialCell lung cancerOral brigatinibRECIST v1.1Advanced malignanciesGrade 1/2Median durationOverall survivalMulticenter trial
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 options
2015
Safety and efficacy of brigatinib (AP26113) in advanced malignancies, including ALK+ non–small cell lung cancer (NSCLC).
Camidge D, Bazhenova L, Salgia R, Langer C, Gold K, Rosell R, Shaw A, Weiss G, Narasimhan N, Dorer D, Rivera V, Clackson T, Conlan M, Kerstein D, Haluska F, Gettinger S. Safety and efficacy of brigatinib (AP26113) in advanced malignancies, including ALK+ non–small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2015, 33: 8062-8062. DOI: 10.1200/jco.2015.33.15_suppl.8062.Peer-Reviewed Original Research99O 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
2014
1292P Alk Inhibitor Ap26113 in Patients with Advanced Malignancies, Including Alk+ Non-Small Cell Lung Cancer (Nsclc): Updated Efficacy and Safety Data
Gettinger S, Bazhenova L, Salgia R, Langer C, Gold K, Rosell R, Shaw A, Weiss G, Narasimhan N, Dorer D, Rivera V, Clackson T, Haluska F, Camidge R. 1292P Alk Inhibitor Ap26113 in Patients with Advanced Malignancies, Including Alk+ Non-Small Cell Lung Cancer (Nsclc): Updated Efficacy and Safety Data. Annals Of Oncology 2014, 25: iv455. DOI: 10.1093/annonc/mdu349.71.Peer-Reviewed Original ResearchBrain metastasesNSCLC ptsAdvanced malignanciesCommon treatment-emergent adverse eventsNon-small cell lung cancerMedian progression-free survivalTreatment-emergent adverse eventsIndependent radiological reviewProgression-free survivalCell lung cancerDuration of responseTyrosine kinase inhibitorsActive tyrosine kinase inhibitorPhase 2 portionAnti-tumor activityEvaluable ptsPrior crizotinibStable diseasePulmonary symptomsFree survivalGrade 1/2Radiological reviewAdverse eventsMulticenter studyLung cancerUpdated efficacy and safety of the ALK inhibitor AP26113 in patients (pts) with advanced malignancies, including ALK+ non-small cell lung cancer (NSCLC).
Gettinger S, Bazhenova L, Salgia R, Langer C, Gold K, Rosell R, Shaw A, Weiss G, Narasimhan N, Dorer D, Rivera V, Clackson T, Haluska F, Camidge D. Updated efficacy and safety of the ALK inhibitor AP26113 in patients (pts) with advanced malignancies, including ALK+ non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2014, 32: 8047-8047. DOI: 10.1200/jco.2014.32.15_suppl.8047.Peer-Reviewed Original ResearchNon-small cell lung cancerCell lung cancerAdvanced malignanciesLung cancerAP26113PatientsMalignancyCancer
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
2009
A phase I study investigating the combination of orally bioavailable platinum and nanoparticle albumin-bound paclitaxel in advanced solid tumors
Deshpande H, Gettinger S, Rowen E, Abu-Khalaf M, Clarke J, Burns A, Kelly W. A phase I study investigating the combination of orally bioavailable platinum and nanoparticle albumin-bound paclitaxel in advanced solid tumors. Journal Of Clinical Oncology 2009, 27: e13501-e13501. DOI: 10.1200/jco.2009.27.15_suppl.e13501.Peer-Reviewed Original ResearchNanoparticle albumin-bound paclitaxelAlbumin-bound paclitaxelCohort 2Cohort 3Cohort 1Platinum agentsSolid tumorsDay 14Common severe adverse eventsGrade 3 anemiaMedian age 51Grade 4 neutropeniaStandard chemotherapy regimenAdvanced solid tumorsPhase 2 studySevere adverse eventsNeurological side effectsCycle 1Stable diseaseChemotherapy regimenDay 1 treatmentAdvanced malignanciesAdverse eventsPartial responseProgressive disease