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dc.contributor.authorLocke, FL
dc.contributor.authorMiklos, DB
dc.contributor.authorJacobson, CA
dc.contributor.authorPerales, M-A
dc.contributor.authorKersten, M-J
dc.contributor.authorOluwole, OO
dc.contributor.authorGhobadi, A
dc.contributor.authorRapoport, AP
dc.contributor.authorMcGuirk, J
dc.contributor.authorPagel, JM
dc.contributor.authorMuñoz, J
dc.contributor.authorFarooq, U
dc.contributor.authorvan Meerten, T
dc.contributor.authorReagan, PM
dc.contributor.authorSureda, A
dc.contributor.authorFlinn, IW
dc.contributor.authorVandenberghe, P
dc.contributor.authorSong, KW
dc.contributor.authorDickinson, M
dc.contributor.authorMinnema, MC
dc.contributor.authorRiedell, PA
dc.contributor.authorLeslie, LA
dc.contributor.authorChaganti, S
dc.contributor.authorYang, Y
dc.contributor.authorFilosto, S
dc.contributor.authorShah, J
dc.contributor.authorSchupp, M
dc.contributor.authorTo, C
dc.contributor.authorCheng, P
dc.contributor.authorGordon, LI
dc.contributor.authorWestin, JR
dc.contributor.authorAll ZUMA-7 Investigators and Contributing Kite Members
dc.date.accessioned2022-02-23T09:39:57Z
dc.date.available2022-02-23T09:39:57Z
dc.identifier.citationThe New England journal of medicine, 2022, 386 (7), pp. 640 - 654en_US
dc.identifier.issn0028-4793
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/5029
dc.identifier.eissn1533-4406en_US
dc.identifier.eissn1533-4406
dc.identifier.doi10.1056/nejmoa2116133en_US
dc.identifier.doi10.1056/nejmoa2116133
dc.description.abstract<h4>Background</h4>The prognosis of patients with early relapsed or refractory large B-cell lymphoma after the receipt of first-line chemoimmunotherapy is poor.<h4>Methods</h4>In this international, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with large B-cell lymphoma that was refractory to or had relapsed no more than 12 months after first-line chemoimmunotherapy to receive axicabtagene ciloleucel (axi-cel, an autologous anti-CD19 chimeric antigen receptor T-cell therapy) or standard care (two or three cycles of investigator-selected, protocol-defined chemoimmunotherapy, followed by high-dose chemotherapy with autologous stem-cell transplantation in patients with a response to the chemoimmunotherapy). The primary end point was event-free survival according to blinded central review. Key secondary end points were response and overall survival. Safety was also assessed.<h4>Results</h4>A total of 180 patients were randomly assigned to receive axi-cel and 179 to receive standard care. The primary end-point analysis of event-free survival showed that axi-cel therapy was superior to standard care. At a median follow-up of 24.9 months, the median event-free survival was 8.3 months in the axi-cel group and 2.0 months in the standard-care group, and the 24-month event-free survival was 41% and 16%, respectively (hazard ratio for event or death, 0.40; 95% confidence interval, 0.31 to 0.51; P<0.001). A response occurred in 83% of the patients in the axi-cel group and in 50% of those in the standard-care group (with a complete response in 65% and 32%, respectively). In an interim analysis, the estimated overall survival at 2 years was 61% in the axi-cel group and 52% in the standard-care group. Adverse events of grade 3 or higher occurred in 91% of the patients who received axi-cel and in 83% of those who received standard care. Among patients who received axi-cel, grade 3 or higher cytokine release syndrome occurred in 6% and grade 3 or higher neurologic events in 21%. No deaths related to cytokine release syndrome or neurologic events occurred.<h4>Conclusions</h4>Axi-cel therapy led to significant improvements, as compared with standard care, in event-free survival and response, with the expected level of high-grade toxic effects. (Funded by Kite; ZUMA-7 ClinicalTrials.gov number, NCT03391466.).en_US
dc.formatPrint-Electronicen_US
dc.format.extent640 - 654en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://www.rioxx.net/licenses/all-rights-reserveden_US
dc.subjectAll ZUMA-7 Investigators and Contributing Kite Membersen_US
dc.titleAxicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma.en_US
dc.typeJournal Article
dcterms.dateAccepted2022-02-17
rioxxterms.versionVoRen_US
rioxxterms.versionofrecord10.1056/nejmoa2116133en_US
dc.relation.isPartOfThe New England journal of medicineen_US
pubs.issue7en_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublisheden_US
pubs.volume386en_US
pubs.embargo.termsNot knownen_US
icr.researchteamMedicine (RMH Smith Cunningham)
dc.contributor.icrauthorCunningham, Daviden_US


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