Long-Term (5 Year) Overall Survival in Zuma-1, the Pivotal Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Refractory Large B-Cell Lymphoma (LBCL)

Jacobson, Caron A.; Locke, Frederick L.; Ghobadi, Armin; Miklos, David B.; Lekakis, Lazaros J.; Oluwole, Olalekan O.; Lin, Yi; Hill, Brian T.; Timmerman, John M.; Deol, Abhinav; Reagan, Patrick M.; Stiff, Patrick J.; Flinn, Ian W.; Farooq, Umar; Goy, André; Muñoz, Javier; Siddiqi, Tanya; Shen, Rhine R.; Bot, Adrian; Dong, Jinghui; Singh, Kirandeep; Spooner, Clare; Karalliyadda, Roshan; Kim, Jaeyeon; Zheng, Yufeng; Neelapu, Sattva S.

doi:10.1016/s2666-6367(22)00171-3

Cited by 10 publications

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“…7 First autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, axicabtagene ciloleucel (Axi-cel), was approved in 2017 for third-line R/R LBCL, followed by approval of tisagenlecleucel (Tisa-cel) in 2018 and lisocabtagene maraleucel (Liso-cel) last year. [8][9][10] With an unprecedented overall response rate (ORR) of 50%-80% and durable responses of 30%-40% at 4-5 years, 11,12 CAR-T therapy is now considered standard of care (SOC) for patients with R/R LBCL after two or more lines of therapy.…”

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Chimeric antigen receptor T‐cell therapy is superior to standard of care as second‐line therapy for large B‐cell lymphoma: A systematic review and meta‐analysis

et al. 2022

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I N TRODUC TIONDespite progress in the up-front treatment of large B-cell lymphoma (LBCL), up to a third of patients with LBCL will be refractory to first-line immuno-chemotherapy or will relapse after achieving complete response (CR). Of them, at least half are unlikely to be eligible for aggressive approaches due to advanced age and comorbidities. Therefore, only 50% of these patients can be approached with curative intent. [1][2][3] Based on the results of the Collaborative Trial in Relapsed Aggressive Lymphoma (CORAL) study, patients with previous rituximab exposure have a response rate to salvage therapy of 50%; therefore, at most, only 25% of all relapsing patients today will undergo autologous stem cell transplantation (ASCT). The 3-year event-free survival (EFS) of those treated with ASCT in the CORAL study was 50%, so only 10% patients of the relapsed/refractory (R/R) patients are

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Chimeric antigen receptor T‐cell therapy is superior to standard of care as second‐line therapy for large B‐cell lymphoma: A systematic review and meta‐analysis

et al. 2022

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“…8,9 In the ZUMA-1 trial, which involved patients with refractory large B-cell lymphoma treated with axi-cel, 83% of the patients had a response and 58% had a complete response 10 ; the median overall survival was 25.8 months, and the 5-year overall survival was 43%. 11 Thus, we conducted ZUMA-7, an international, randomized, phase 3 trial comparing axicel with standard care as second-line treatment in patients with early relapsed or refractory large B-cell lymphoma. We report here the results of the primary and key secondary analyses.…”

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Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma

et al. 2022

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BACKGROUNDThe prognosis of patients with early relapsed or refractory large B-cell lymphoma after the receipt of first-line chemoimmunotherapy is poor. METHODSIn 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. RESULTSA 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 standardcare 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. CONCLUSIONSAxi-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.

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“…Relapsed or refractory DLBCL patients after two lines of systemic therapy have previously been characterized by very poor clinical outcomes with only limited therapeutic options [17]. Recently, however, long-term CAR T cell therapy studies have demonstrated improved outcome, with 44% of DLBCL patients in third line surviving beyond 4 years after having received CAR T cell therapy [18]. More recent studies also demonstrate promising results of CAR T cell therapies in DLBCL patients after first relapse in direct comparison with the current standard of care high-dose chemotherapy and autologous stem cell transplant [19,20], with one of these CAR T cell therapies having been approved by the FDA [7].…”

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Barriers to patient access of CAR T cell therapies in Austria

Hopfinger

Rupp

Greil

2023

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SummaryChimeric antigen receptor (CAR) T cell therapies offer a promising new therapeutic option for treating B cell malignancies, for instance relapsed or refractory diffuse large B cell lymphoma (DLBCL). However, patient access to this type of cellular immunotherapy may be limited due to systemic barriers even in wealthy Western countries. In Austria, the CAR T eligible DLBCL population is estimated to encompass approximately 56 patients based on the criteria applied for CAR T registrational trials. However, less than 40% of these DLBCL patients eligible for commercial standard-of-care CAR T cell therapy were finally treated with CAR T cell therapy in 2021 based on our analysis. This report discusses potential barriers that may impede current patient access to CAR T cell therapy and provides recommendations for systemic solutions to address these barriers and improve the CAR T access situation in Austria.

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Long-Term (5 Year) Overall Survival in Zuma-1, the Pivotal Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Refractory Large B-Cell Lymphoma (LBCL)

Cited by 10 publications

References 0 publications

Chimeric antigen receptor T‐cell therapy is superior to standard of care as second‐line therapy for large B‐cell lymphoma: A systematic review and meta‐analysis

Chimeric antigen receptor T‐cell therapy is superior to standard of care as second‐line therapy for large B‐cell lymphoma: A systematic review and meta‐analysis

Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma

Barriers to patient access of CAR T cell therapies in Austria

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