dc.contributor.author | Locke, FL | |
dc.contributor.author | Miklos, DB | |
dc.contributor.author | Jacobson, CA | |
dc.contributor.author | Perales, M-A | |
dc.contributor.author | Kersten, M-J | |
dc.contributor.author | Oluwole, OO | |
dc.contributor.author | Ghobadi, A | |
dc.contributor.author | Rapoport, AP | |
dc.contributor.author | McGuirk, J | |
dc.contributor.author | Pagel, JM | |
dc.contributor.author | Muñoz, J | |
dc.contributor.author | Farooq, U | |
dc.contributor.author | van Meerten, T | |
dc.contributor.author | Reagan, PM | |
dc.contributor.author | Sureda, A | |
dc.contributor.author | Flinn, IW | |
dc.contributor.author | Vandenberghe, P | |
dc.contributor.author | Song, KW | |
dc.contributor.author | Dickinson, M | |
dc.contributor.author | Minnema, MC | |
dc.contributor.author | Riedell, PA | |
dc.contributor.author | Leslie, LA | |
dc.contributor.author | Chaganti, S | |
dc.contributor.author | Yang, Y | |
dc.contributor.author | Filosto, S | |
dc.contributor.author | Shah, J | |
dc.contributor.author | Schupp, M | |
dc.contributor.author | To, C | |
dc.contributor.author | Cheng, P | |
dc.contributor.author | Gordon, LI | |
dc.contributor.author | Westin, JR | |
dc.contributor.author | All ZUMA-7 Investigators and Contributing Kite Members | |
dc.date.accessioned | 2022-02-23T09:39:57Z | |
dc.date.available | 2022-02-23T09:39:57Z | |
dc.identifier.citation | The New England journal of medicine, 2022, 386 (7), pp. 640 - 654 | en_US |
dc.identifier.issn | 0028-4793 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5029 | |
dc.identifier.eissn | 1533-4406 | en_US |
dc.identifier.eissn | 1533-4406 | |
dc.identifier.doi | 10.1056/nejmoa2116133 | en_US |
dc.identifier.doi | 10.1056/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.format | Print-Electronic | en_US |
dc.format.extent | 640 - 654 | en_US |
dc.language | eng | en_US |
dc.language.iso | eng | en_US |
dc.rights.uri | http://www.rioxx.net/licenses/all-rights-reserved | en_US |
dc.subject | All ZUMA-7 Investigators and Contributing Kite Members | en_US |
dc.title | Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-02-17 | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1056/nejmoa2116133 | en_US |
dc.relation.isPartOf | The New England journal of medicine | en_US |
pubs.issue | 7 | en_US |
pubs.notes | Not known | en_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-status | Published | en_US |
pubs.volume | 386 | en_US |
pubs.embargo.terms | Not known | en_US |
icr.researchteam | Medicine (RMH Smith Cunningham) | |
dc.contributor.icrauthor | Cunningham, David | |