{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,10]],"date-time":"2026-11-10T01:31:13Z","timestamp":1794274273118,"version":"4.9.0"},"reference-count":45,"publisher":"Springer Science and Business Media LLC","issue":"10","license":[{"start":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T00:00:00Z","timestamp":1694649600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T00:00:00Z","timestamp":1694649600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Kite, a Gilead company"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Nat Med"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Axicabtagene ciloleucel (axi-cel) demonstrated superior efficacy compared to standard of care as second-line therapy in patients with high-risk relapsed\/refractory (R\/R) large B cell lymphoma (LBCL) considered eligible for autologous stem cell transplantation (ASCT); however, in clinical practice, roughly half of patients with R\/R LBCL are deemed unsuitable candidates for ASCT. The efficacy of axi-cel remains to be ascertained in transplant-ineligible patients. ALYCANTE, an open-label, phase 2 study, evaluated axi-cel as a second-line therapy in 62 patients with R\/R LBCL who were considered ineligible for ASCT. The primary end point was investigator-assessed complete metabolic response at 3 months from the axi-cel infusion. Key secondary end points included progression-free survival, overall survival and safety. The study met its primary end point with a complete metabolic response of 71.0% (95% confidence interval, 58.1\u201381.8%) at 3 months. With a median follow-up of 12.0 months (range, 2.1\u201317.9), median progression-free survival was 11.8 months (95% confidence interval, 8.4\u2013not reached) and overall survival was not reached. There was no unexpected toxicity. Grade 3\u20134 cytokine release syndrome and neurologic events occurred in 8.1% and 14.5% of patients, respectively. These results support axi-cel as second-line therapy in patients with R\/R LBCL ineligible for ASCT. ClinicalTrials.gov Identifier:\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04531046\">NCT04531046<\/jats:ext-link>\n                    .\n                  <\/jats:p>","DOI":"10.1038\/s41591-023-02572-5","type":"journal-article","created":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T11:16:26Z","timestamp":1694690186000},"page":"2593-2601","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":110,"title":["Axicabtagene ciloleucel as second-line therapy in large B cell lymphoma ineligible for autologous stem cell transplantation: a phase 2 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E.B. has received honoraria from Kite\/Gilead, Bristol-Myers Squibb, Novartis, Pfizer, Incyte, ADC Therapeutics, Roche and Takeda; travel reimbursement from Kite\/Gilead, Bristol-Myers Squibb, Novartis and Pfizer; and research funding from Amgen and Bristol-Myers Squibb. G.C. has received consulting fees from Roche, AbbVie, Bristol-Myers Squibb, MedXCell, Mabqi and Onward Therapeutics; honoraria from Jansen, Gilead, Novartis, Roche, Bristol-Myers Squibb and Incyte; and travel and accommodation expenses from Gilead, Roche and Jansen. F.X.G. has received consulting fees from Gilead, Bristol-Myers Squibb, Miltenyi and Novartis; and travel and accommodation expenses from Gilead and Novartis. F.M. has received consulting fees from Roche, Gilead, Novartis, Bristol-Myers Squibb, Genmab and AbbVie; and honoraria for advisory boards from Roche, Gilead and Miltenyi. L.O. has received consulting fees from Roche; honoraria from Bristol-Myers Squibb, Kite\/Gilead and Incyte; and travel and accommodation expenses from Roche and AstraZeneca. T.G. has received consulting fees from Takeda and Kite\/Gilead; honoraria from Kite\/Gilead; and travel and accommodation expenses from Roche, Takeda and Kite\/Gilead. P.F. has received consulting fees from Gilead, AstraZeneca, BeiGene, AbbVie and Janssen; honoraria from Gilead, AstraZeneca, BeiGene, AbbVie and Janssen; and travel and accommodation expenses from Gilead, AstraZeneca, BeiGene, AbbVie and Janssen. R.D. has received honoraria from Novartis and Takeda; research funding from Ligue contre le Cancer, Arthur Sachs, Monahan Foundation, Servier Foundation, Philippe Foundation and DCP AP-HP; and non-financial support from Kite\/Gilead. C.T. has received institutional research funding from Kite\/Gilead and Roche; honoraria for advisory boards from Roche, Novartis, AstraZeneca, BeiGene, AbbVie, Takeda, Roche, Novartis, Kite\/Gilead, Bristol-Myers Squibb; and travel and accommodation expenses from Roche, Novartis, AbbVie, Takeda, Roche, Kite\/Gilead and Bristol-Myers Squibb. F.J. has received honoraria from Roche, Gilead, Janssen and Bristol-Myers Squibb; honoraria for advisory boards from Roche; and travel and accommodation expenses from Roche and Gilead. S.C. has received consulting fees from Atara, Novartis, Kite\/Gilead, Pierre Fabre, Takeda, AbbVie and AstraZeneca; honoraria for advisory boards from Kite\/Gilead, Novartis, AbbVie, Takeda and Viatris; institutional funding from Janssen; and travel and accommodation expenses from Novartis, AbbVie and Pierre Fabre. O.C. has received honoraria from Roche, Takeda, Bristol-Myers Squibb, Merck, Kite\/Gilead, AbbVie and ADC Therapeutics; and research funding from Roche, Takeda and Kite\/Gilead. G.B. has received honoraria for advisory boards from Novartis, Kite\/Gilead, Bristol-Myers Squibb and Incyte; and travel and accommodation expenses from Novartis, Kite\/Gilead, Bristol-Myers Squibb and Incyte. M.C. has received institutional research funding from AP-HP, INSERM, INCA, Fondation ARC pour la Recherche sur le Cancer and CALYM; honoraria from Amgen and CSL Behring; research funding from Innate Pharma and Servier; and travel and accommodation expenses from Pfizer, Grifols, CSL Behring and Gilead. F.L.G. has received honoraria from Rennes University Hospital. C.M. has received research funding from Kite Pharmaceuticals. C.P. is a LYSARC employee. E.I. has received honoraria from Janssen-Cilag and Pfizer. C.L. has received research funding from Ligue contre le Cancer and Labex Toucan; and travel and accommodation expenses from Roche and Janssen. All other authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}