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 signalsNSCLCPatientsAssociation of depth of target lesion response to brigatinib with outcomes in patients with ALK inhibitor-naive ALK+ NSCLC in ALTA-1L.
Camidge D, Kim H, Ahn M, Yang J, Han J, Hochmair M, Lee K, Delmonte A, Campelo R, Kim D, Griesinger F, Felip E, Califano R, Spira A, Thomas M, Gettinger S, Tiseo M, Liu Y, Zhang P, Popat S. Association of depth of target lesion response to brigatinib with outcomes in patients with ALK inhibitor-naive ALK+ NSCLC in ALTA-1L. Journal Of Clinical Oncology 2022, 40: 9072-9072. DOI: 10.1200/jco.2022.40.16_suppl.9072.Peer-Reviewed Original ResearchBlinded independent review committeeTarget lesion assessmentTarget lesion responseLesion shrinkageLesion responseLesion assessmentCochran-Armitage trend analysisRandomized phase 3 trialShrinkage groupPhase 3 trialDepth of responseIndependent review committeeLonger median timeMajority of ptsAssociation of depthRECIST v1.1PFS eventsMedian ageOS ratesMedian timeStudy endTarget lesionsLower riskDeep responsesBrigatinib