{"entity":{"id":"zuma-7","kind":"trial","name":"ZUMA-7","aka":[],"tldr":"The trial that moved CAR-T ahead of transplant as second-line treatment for early-relapsing large B-cell lymphoma, with a survival benefit.","summary":"ZUMA-7, trial NCT03391466 sponsored by Kite and Gilead and published in the New England Journal of Medicine in 2022 with survival results in 2023, moved CAR-T ahead of transplant as second-line treatment for large B-cell lymphoma that is refractory or relapses within twelve months of first-line therapy. It randomised 359 patients to axicabtagene ciloleucel or salvage chemotherapy followed by autologous transplant, met its primary event-free survival endpoint with a large effect and later showed an overall survival benefit, while only about a third of the standard arm ever reached transplant, leading to approval in the second line in April 2022. OnCo links it to lymphoma, CAR-T, autologous transplant, axi-cel, Sattva S. Neelapu, Jason R. Westin, Frederick L. Locke and the manufacturing bottleneck. Whether CAR-T should move into the first line for high-risk patients is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03391466","url":"https://clinicaltrials.gov/study/NCT03391466"},{"label":"OS analysis NEJM 2023","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2301665"}],"tags":[],"related":["lymphoma-roadmap","belinda","transcend-nhl-001","lymphoma-ev-manufacturing-time-as-a-trial-endpoint"],"cancers":["dlbcl"],"sections":[],"technologies":["car-t","autologous-stem-cell-transplant"],"targets":[],"drugs":["axicabtagene-ciloleucel"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":["efs","os"],"trials":[],"people":["sattva-neelapu","jason-westin","frederick-locke"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03391466","phase":"3","setting":"Large B-cell lymphoma refractory or relapsed within 12 months of frontline therapy: axi-cel vs salvage chemotherapy + autologous transplant","sponsor":"Kite / Gilead","result":"EFS HR 0.40; OS HR 0.73; 4-year OS 54.6% vs 46.0%.","started":"2018-01-25","startedType":"actual","yearReported":2021,"enrolled":359,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Axi-cel","n":180,"value":8.3},{"name":"Standard care","n":179,"value":2}],"hr":0.4,"ci":[0.31,0.51],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2116133"},{"endpoint":"Overall survival at 4 years","unit":"%","arms":[{"name":"Axi-cel","value":54.6},{"name":"Standard care","value":46}],"hr":0.73,"ci":[0.54,0.98],"p":"0.03","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2301665"}],"replication":"TRANSFORM (liso-cel) confirmed the second-line CAR-T EFS benefit; BELINDA (tisagenlecleucel) was negative, attributed to design and bridging differences."},"route":"/trials/zuma-7/","neighbours":{"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"trial":[{"id":"belinda","kind":"trial","name":"BELINDA","route":"/trials/belinda/"},{"id":"juliet","kind":"trial","name":"JULIET","route":"/trials/juliet/"},{"id":"transcend-nhl-001","kind":"trial","name":"TRANSCEND NHL 001","route":"/trials/transcend-nhl-001/"}],"idea":[{"id":"idea-fund-public-car-t-manufacturing","kind":"idea","name":"Hospital-based CAR-T manufacturing at cost through a public network","route":"/ideas/idea-fund-public-car-t-manufacturing/"},{"id":"idea-reg-point-of-care-cart-network","kind":"idea","name":"Hospital-made CAR-T under one shared regulatory master file","route":"/ideas/idea-reg-point-of-care-cart-network/"},{"id":"idea-reg-in-vivo-cart-off-the-shelf-vial","kind":"idea","name":"In vivo CAR-T as a vial on the shelf: a cost and access trial in lymphoma","route":"/ideas/idea-reg-in-vivo-cart-off-the-shelf-vial/"},{"id":"idea-reg-non-viral-cart-manufacturing","kind":"idea","name":"Non-viral CAR-T (transposon or CRISPR knock-in) as the default manufacturing route","route":"/ideas/idea-reg-non-viral-cart-manufacturing/"},{"id":"lymphoma-ev-manufacturing-time-as-a-trial-endpoint","kind":"idea","name":"Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote","route":"/ideas/lymphoma-ev-manufacturing-time-as-a-trial-endpoint/"}],"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"primary-mediastinal-b-cell-lymphoma","kind":"cancer","name":"Primary mediastinal (thymic) large B-cell lymphoma","route":"/cancers/primary-mediastinal-b-cell-lymphoma/"}],"technology":[{"id":"autologous-stem-cell-transplant","kind":"technology","name":"Autologous stem cell transplant (high-dose therapy)","route":"/technologies/autologous-stem-cell-transplant/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"drug":[{"id":"axicabtagene-ciloleucel","kind":"drug","name":"Axicabtagene ciloleucel","route":"/drugs/axicabtagene-ciloleucel/"}],"company":[{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"}],"term":[{"id":"autologous-transplant","kind":"term","name":"Autologous stem cell transplant (ASCT)","route":"/terms/autologous-transplant/"},{"id":"bridging-therapy","kind":"term","name":"Bridging therapy","route":"/terms/bridging-therapy/"},{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"id":"lymphoma-tx-failed-and-negative","kind":"term","name":"Lymphoma treatments that did not work: the negative trials worth knowing","route":"/terms/lymphoma-tx-failed-and-negative/"},{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"},{"id":"salvage-therapy","kind":"term","name":"Salvage therapy","route":"/terms/salvage-therapy/"},{"id":"lymphoma-tx-transplant-role","kind":"term","name":"Stem cell transplant in lymphoma: what it is still for","route":"/terms/lymphoma-tx-transplant-role/"},{"id":"lymphoma-tx-car-t-pathway","kind":"term","name":"The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting","route":"/terms/lymphoma-tx-car-t-pathway/"},{"id":"lymphoma-decision-transplant-or-car-t","kind":"term","name":"Transplant or CAR-T at second line in diffuse large B-cell lymphoma","route":"/terms/lymphoma-decision-transplant-or-car-t/"}],"person":[{"id":"frederick-locke","kind":"person","name":"Frederick L. Locke","route":"/people/frederick-locke/"},{"id":"jason-westin","kind":"person","name":"Jason R. Westin","route":"/people/jason-westin/"},{"id":"sattva-neelapu","kind":"person","name":"Sattva S. Neelapu","route":"/people/sattva-neelapu/"}],"pairing":[{"id":"car-t-before-transplant-lbcl","kind":"pairing","name":"Early relapse: CAR-T before transplant","route":"/pairings/car-t-before-transplant-lbcl/"}],"paper":[{"id":"paper-belinda-tisagenlecleucel-second-line-nejm-2022","kind":"paper","name":"Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma","route":"/key-papers/paper-belinda-tisagenlecleucel-second-line-nejm-2022/"},{"id":"paper-transform-liso-cel-lancet-2022","kind":"paper","name":"TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma","route":"/key-papers/paper-transform-liso-cel-lancet-2022/"},{"id":"paper-zuma-1-axi-cel-nejm-2017","kind":"paper","name":"ZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma","route":"/key-papers/paper-zuma-1-axi-cel-nejm-2017/"},{"id":"paper-zuma-7-axi-cel-second-line-nejm-2022","kind":"paper","name":"ZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early","route":"/key-papers/paper-zuma-7-axi-cel-second-line-nejm-2022/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"}]}}