Axicabtagene ciloleucel (KTE-C19), an anti-CD19 CAR T therapy for the treatment of relapsed/refractory aggressive B-cell non-Hodgkin’s lymphoma

References

• HowladerNNooneAKrapchoMSEER Cancer Statistics Review, 1975–2012, Based On November 2014 SEER Data Submission, Posted to the SEER Web Site, April 2015Bethesda, MD, USANational Cancer Institute2015 Forrás: Available from: http://seercancergov/csr/1975_2010/(2015 június 10 17: 41)Accessed November 1, 2017
   Google Scholar
• SwerdlowSHCampoEPileriSAThe 2016 revision of the World Health Organization classification of lymphoid neoplasmsBlood2016127202375239026980727
   PubMed Web of Science ®Google Scholar
• International Non-Hodgkin’s Lymphoma Prognostic Factors ProjectA predictive model for aggressive non-Hodgkin’s lymphomaN Engl J Med1993329149879948141877
   PubMed Web of Science ®Google Scholar
• SehnLHBerryBChhanabhaiMThe revised International Prognostic Index (R-IPI) is a better predictor of outcome than the standard IPI for patients with diffuse large B-cell lymphoma treated with R-CHOPBlood200710951857186117105812
   PubMed Web of Science ®Google Scholar
• ZhouZSehnLHRademakerAWAn enhanced International Prognostic Index (NCCN-IPI) for patients with diffuse large B-cell lymphoma treated in the rituximab eraBlood2014123683784224264230
   PubMed Web of Science ®Google Scholar
• El-GalalyTCVillaDAlzahraniMOutcome prediction by extranodal involvement, IPI, R-IPI, and NCCN-IPI in the PET/CT and rituximab era: a Danish-Canadian study of 443 patients with diffuse-large B-cell lymphomaAm J Hematol201590111041104626260224
   PubMed Web of Science ®Google Scholar
• PasqualucciLTrifonovVFabbriGAnalysis of the coding genome of diffuse large B-cell lymphomaNat Genet201143983083721804550
   PubMed Web of Science ®Google Scholar
• ZhangJGruborVLoveCLGenetic heterogeneity of diffuse large B-cell lymphomaProc Natl Acad Sci U S A201311041398140323292937
   PubMed Web of Science ®Google Scholar
• RosenwaldAWrightGChanWCLeukemia Molecular Profiling ProjectThe use of molecular profiling to predict survival after chemotherapy for diffuse large-B-cell lymphomaN Engl J Med2002346251937194712075054
   PubMed Web of Science ®Google Scholar
• AlizadehAAEisenMBDavisREDistinct types of diffuse large B-cell lymphoma identified by gene expression profilingNature2000403676950351110676951
   PubMed Web of Science ®Google Scholar
• LenzGWrightGDaveSSLymphoma/Leukemia Molecular Profiling ProjectStromal gene signatures in large-B-cell lymphomasN Engl J Med2008359222313232319038878
   PubMed Web of Science ®Google Scholar
• HansCPWeisenburgerDDGreinerTCConfirmation of the molecular classification of diffuse large B-cell lymphoma by immunohistochemistry using a tissue microarrayBlood2004103127528214504078
   PubMed Web of Science ®Google Scholar
• ViscoCLiYXu-MonetteZYComprehensive gene expression profiling and immunohistochemical studies support application of immunophenotypic algorithm for molecular subtype classification in diffuse large B-cell lymphoma: a report from the International DLBCL Rituximab-CHOP Consortium Program StudyLeukemia20122692103211322437443
   PubMed Web of Science ®Google Scholar
• ScottDWMottokAEnnishiDPrognostic significance of diffuse large B-cell lymphoma cell of origin determined by digital gene expression in formalin-fixed paraffin-embedded tissue biopsiesJ Clin Oncol201533262848285626240231
   PubMed Web of Science ®Google Scholar
• AdhikarySEilersMTranscriptional regulation and transformation by Myc proteinsNat Rev Mol Cell Biol20056863564516064138
   PubMed Web of Science ®Google Scholar
• SavageKJJohnsonNABen-NeriahSMYC gene rearrangements are associated with a poor prognosis in diffuse large B-cell lymphoma patients treated with R-CHOP chemotherapyBlood2009114173533353719704118
   PubMed Web of Science ®Google Scholar
• BarransSCrouchSSmithARearrangement of MYC is associated with poor prognosis in patients with diffuse large B-cell lymphoma treated in the era of rituximabJ Clin Oncol201028203360336520498406
   PubMed Web of Science ®Google Scholar
• HornHZiepertMBecherCGerman High-Grade Non-Hodgkin Lymphoma Study GroupMYC status in concert with BCL2 and BCL6 expression predicts outcome in diffuse large B-cell lymphomaBlood2013121122253226323335369
   PubMed Web of Science ®Google Scholar
• JohnsonNASlackGWSavageKJConcurrent expression of MYC and BCL2 in diffuse large B-cell lymphoma treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisoneJ Clin Oncol201230283452345922851565
   PubMed Web of Science ®Google Scholar
• PetrichAMGandhiMJovanovicBImpact of induction regimen and stem cell transplantation on outcomes in double-hit lymphoma: a multicenter retrospective analysisBlood2014124152354236125161267
   PubMed Web of Science ®Google Scholar
• OkiYNooraniMLinPDouble hit lymphoma: the MD Anderson Cancer Center clinical experienceBr J Haematol2014166689190124943107
   PubMed Web of Science ®Google Scholar
• HowlettCSnedecorSJLandsburgDJFront-line, dose-escalated immunochemotherapy is associated with a significant progression-free survival advantage in patients with double-hit lymphomas: a systematic review and meta-analysisBr J Haematol2015170450451425907897
   PubMed Web of Science ®Google Scholar
• CoiffierBThieblemontCVan Den NesteELong-term outcome of patients in the LNH-98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a study by the Groupe d’Etudes des Lymphomes de l’AdulteBlood20101161220402045 French20548096
   PubMed Web of Science ®Google Scholar
• GisselbrechtCGlassBMounierNSalvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab eraJ Clin Oncol201028274184419020660832
   PubMed Web of Science ®Google Scholar
• MaurerMJGhesquieresHJaisJPEvent-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapyJ Clin Oncol201432101066107324550425
   PubMed Web of Science ®Google Scholar
• CrumpMKuruvillaJCoubanSRandomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12J Clin Oncol201432313490349625267740
   PubMed Web of Science ®Google Scholar
• Van Den NesteESchmitzNMounierNOutcomes of diffuse large B-cell lymphoma patients relapsing after autologous stem cell transplantation: an analysis of patients included in the CORAL studyBone Marrow Transplant201752221622127643872
   PubMed Web of Science ®Google Scholar
• Van Den NesteESchmitzNMounierNOutcome of patients with relapsed diffuse large B-cell lymphoma who fail second-line salvage regimens in the International CORAL studyBone Marrow Transplant2016511515726367239
   PubMed Web of Science ®Google Scholar
• NagleSJWooKSchusterSJOutcomes of patients with relapsed/refractory diffuse large B-cell lymphoma with progression of lymphoma after autologous stem cell transplantation in the rituximab eraAm J Hematol2013881089089423813874
   PubMed Web of Science ®Google Scholar
• CrumpMNeelapuSSFarooqUOutcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 studyBlood2017130161800180828774879
   PubMed Web of Science ®Google Scholar
• CostaLJMaddocksKEpperlaNDiffuse large B-cell lymphoma with primary treatment failure: ultra-high risk features and benchmarking for experimental therapiesAm J Hematol201792216117027880984
   PubMed Web of Science ®Google Scholar
• YangYCancer immunotherapy: harnessing the immune system to battle cancerJ Clin Invest201512593335333726325031
   PubMed Web of Science ®Google Scholar
• KochenderferJNWilsonWHJanikJEEradication of B-lineage cells and regression of lymphoma in a patient treated with autologous T cells genetically engineered to recognize CD19Blood2010116204099410220668228
   PubMed Web of Science ®Google Scholar
• KochenderferJNFeldmanSAZhaoYConstruction and preclinical evaluation of an anti-CD19 chimeric antigen receptorJ Immunother200932768970219561539
   PubMed Web of Science ®Google Scholar
• SavoldoBRamosCALiuECD28 costimulation improves expansion and persistence of chimeric antigen receptor-modified T cells in lymphoma patientsJ Clin Invest201112151822182621540550
   PubMed Web of Science ®Google Scholar
• van der StegenSJHamiehMSadelainMThe pharmacology of second-generation chimeric antigen receptorsNat Rev Drug Discov201514749950926129802
   PubMed Web of Science ®Google Scholar
• ScheuermannRHRacilaECD19 antigen in leukemia and lymphoma diagnosis and immunotherapyLeuk Lymphoma1995185–63853978528044
   PubMed Web of Science ®Google Scholar
• BrentjensRJLatoucheJBSantosEEradication of systemic B-cell tumors by genetically targeted human T lymphocytes co-stimulated by CD80 and interleukin-15Nat Med20039327928612579196
   PubMed Web of Science ®Google Scholar
• KochenderferJNYuZFrasheriDRestifoNPRosenbergSAAdoptive transfer of syngeneic T cells transduced with a chimeric antigen receptor that recognizes murine CD19 can eradicate lymphoma and normal B cellsBlood2010116193875388620631379
   PubMed Web of Science ®Google Scholar
• MadanRAGulleyJLFojoTDahutWLTherapeutic cancer vaccines in prostate cancer: the paradox of improved survival without changes in time to progressionOncologist201015996997520798195
   PubMed Web of Science ®Google Scholar
• BrudnoJNKochenderferJNToxicities of chimeric antigen receptor T cells: recognition and managementBlood2016127263321333027207799
   PubMed Web of Science ®Google Scholar
• Yescarta (axicabtagene ciloleucel) [package insert]Santa Monica, CA, USAKite Pharma, Inc;2017
   Google Scholar
• NeelapuSSLockeFLBartlettNLAxicabtagene Ciloleucel CAR T-cell therapy in refractory large B-cell lymphomaN Engl J Med2017377262531254429226797
   PubMed Web of Science ®Google Scholar
• NeelapuSSLockeFLBartlettNLLong-term follow-up ZUMA-1: a pivotal trial of Axicabtagene Ciloleucel (Axi-Cel; KTE-C19) in patients with refractory aggressive Non-Hodgkin Lymphoma (NHL)Blood2017130Suppl 1578
   Google Scholar
• TurtleCJHanafiLABergerCImmunotherapy of non-Hodgkin’s lymphoma with a defined ratio of CD8+ and CD4+ CD19-specific chimeric antigen receptor-modified T cellsSci Transl Med20168355355ra116
   PubMed Web of Science ®Google Scholar
• KochenderferJNSomervilleRPTLuTLymphoma remissions caused by Anti-CD19 chimeric antigen receptor T cells are associated with high serum interleukin-15 levelsJ Clin Oncol201735161803181328291388
   PubMed Web of Science ®Google Scholar
• LockeFLNeelapuSSBartlettNLPhase 1 results of ZUMA-1: a Multicenter Study of KTE-C19 Anti-CD19 CAR T cell therapy in refractory aggressive lymphomaMol Ther201725128529528129122
   PubMed Web of Science ®Google Scholar
• KochenderferJNSomervilleRPTLuTLong-duration complete remissions of diffuse large B cell lymphoma after Anti-CD19 chimeric antigen receptor T cell therapyMol Ther201725102245225328803861
   PubMed Web of Science ®Google Scholar
• LeeDWKochenderferJNStetler-StevensonMT cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trialLancet2015385996751752825319501
   PubMed Web of Science ®Google Scholar
• MaudeSLFreyNShawPAChimeric antigen receptor T cells for sustained remissions in leukemiaN Engl J Med2014371161507151725317870
   PubMed Web of Science ®Google Scholar
• MausMVJuneCHMaking better chimeric antigen receptors for adoptive T-cell therapyClin Cancer Res20162281875188427084741
   PubMed Web of Science ®Google Scholar
• RobertsZJBetterMBotARobertsMRRibasAAxicabtagene ciloleucel, a first-in-class CAR T cell therapy for aggressive NHLLeuk Lymphoma Epub20171023
   Web of Science ®Google Scholar
• WangXRiviereIClinical manufacturing of CAR T cells: foundation of a promising therapyMol Ther Oncolytics201631601527347557
   PubMed Web of Science ®Google Scholar
• BetterMChiruvoluVOliverJ287. Production of KTE-C19 (Anti-CD19 CAR T Cells) for ZUMA-1: a Phase 1/2 Multi-Center Study evaluating safety and efficacy in subjects with refractory aggressive Non-Hodgkin Lymphoma (NHL)Mol Ther201624Suppl 1S115
   Web of Science ®Google Scholar
• ChesonBDThe International Harmonization Project for response criteria in lymphoma clinical trialsHematol Oncol Clin North Am200721584185417908623
   PubMed Web of Science ®Google Scholar
• ChesonBDFisherRIBarringtonSFRecommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classificationJ Clin Oncol201432273059306825113753
   PubMed Web of Science ®Google Scholar
• KochenderferJNDudleyMEKassimSHChemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptorJ Clin Oncol201533654054925154820
   PubMed Web of Science ®Google Scholar
• LossosISPaltielOPolliackASalvage chemotherapy using a combination of fludarabine and cyclophosphamide for refractory or relapsing indolent and aggressive non-Hodgkin’s lymphomasLeuk Lymphoma1999331–215516010194133
   PubMed Web of Science ®Google Scholar
• ZajaFRogatoARussoDMarinLSilvestriFBaccaraniMCombined therapy with Fludarabine and cyclophosphamide in relapsed/resistant patients with B-cell chronic lymphocytic leukaemia and non-Hodgkin’s lymphomasEur J Haematol19975953273289414645
   PubMed Web of Science ®Google Scholar
• RedmanJRCabanillasFVelasquezWSPhase II trial of fludarabine phosphate in lymphoma: an effective new agent in low-grade lymphomaJ Clin Oncol19921057907941373760
   PubMed Web of Science ®Google Scholar
• SchusterSJSvobodaJChongEAChimeric antigen receptor T cells in refractory B-cell lymphomasN Engl J Med2017377262545255429226764
   PubMed Web of Science ®Google Scholar
• AbramsonJSPalombaMLGordonLIHigh durable CR rates in Relapsed/Refractory (R/R) aggressive B-NHL treated with the CD19-directed CAR T cell product JCAR017 (TRANSCEND NHL 001): defined composition allows for dose-finding and definition of pivotal cohortBlood201713058128584136
   PubMed Web of Science ®Google Scholar
• JainMDDavilaMLConcise review: emerging principles from the clinical application of chimeric antigen receptor T cell therapies for B cell malignanciesStem Cells2018361364429024301
   PubMed Web of Science ®Google Scholar
• NeelapuSSLockeFLBartlettNLAxicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphomaN Engl J Med2017377262531254429226797
   PubMed Web of Science ®Google Scholar
• LockeFLRossiJNeelapuSSProduct characteristics associated with in vivo expansion of anti-CD19 CAR T cells in patients treated with axicabtagene ciloleucel (axi-cel)J Clin Oncol20173515 Suppl3023
   Web of Science ®Google Scholar
• NeelapuSSTummalaSKebriaeiPChimeric antigen receptor T-cell therapy – assessment and management of toxicitiesNat Rev Clin Oncol2018151476228925994
   PubMed Web of Science ®Google Scholar
• LeeDWGardnerRPorterDLCurrent concepts in the diagnosis and management of cytokine release syndromeBlood2014124218819524876563
   PubMed Web of Science ®Google Scholar
• DavilaMLRiviereIWangXEfficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemiaSci Transl Med20146224224ra225
   Web of Science ®Google Scholar
• GustJHayKAHanafiLAEndothelial activation and blood-brain barrier disruption in neurotoxicity after adoptive immunotherapy with CD19 CAR-T cellsCancer Discov20177121404141929025771
   PubMed Web of Science ®Google Scholar
• HayKAHanafiLALiDKinetics and biomarkers of severe cytokine release syndrome after CD19 chimeric antigen receptor-modified T-cell therapyBlood2017130212295230628924019
   PubMed Web of Science ®Google Scholar
• LockeFLAnasettiCMoffitt Immunotherapy Working Group and the Immune Cell Therapy (ICE-T) ProgramTransplanters drive CARs to the clinic by brewing ICE-T: the Moffitt roadmapJ Immunother Cancer2017515928716155
   PubMed Web of Science ®Google Scholar
• LevineBLMiskinJWonnacottKKeirCGlobal manufacturing of CAR T cell therapyMol Ther Methods Clin Dev201749210128344995
   PubMed Web of Science ®Google Scholar
• RosenbaumLTragedy, perseverance, and chance – The story of CAR-T therapyN Engl J Med2017377141313131528902570
   PubMed Web of Science ®Google Scholar