Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma
Oluwole, Olalekan O; Bouabdallah, Krimo; Muñoz, Javier; De Guibert, Sophie; Vose, Julie M; Bartlett, Nancy L; Lin, Yi; Deol, Abhinav; McSweeney, Peter A; Goy, Andre H; Kersten, Marie José; Jacobson, Caron A; Farooq, Umar; Minnema, Monique C; Thieblemont, Catherine; Timmerman, John M; Stiff, Patrick; Avivi, Irit; Tzachanis, Dimitrios; Kim, Jenny J; Bashir, Zahid; McLeroy, Jeff; Zheng, Yan; Rossi, John M; Johnson, Lisa; Goyal, Lovely; van Meerten, Tom
(2021) British Journal of Haematology, volume 194, issue 4, pp. 690 - 700
(Article)
Abstract
ZUMA-1 (NCT02348216) examined the safety and efficacy of axicabtagene ciloleucel (axi-cel), an autologous CD19-directed chimaeric antigen receptor (CAR)-T cell therapy, in refractory large B-cell lymphoma. To reduce treatment-related toxicity, several exploratory safety management cohorts were added to ZUMA-1. Specifically, cohort 6 investigated management of cytokine release syndrome (CRS) and neurologic
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events (NEs) with prophylactic corticosteroids and earlier corticosteroid and tocilizumab intervention. CRS and NE incidence and severity were primary end-points. Following leukapheresis, patients could receive optional bridging therapy per investigator discretion. All patients received conditioning chemotherapy (days -5 through -3), 2 × 106 CAR-T cells/kg (day 0) and once-daily oral dexamethasone [10 mg, day 0 (before axi-cel) through day 2]. Forty patients received axi-cel. CRS occurred in 80% of patients (all grade ≤2). Any grade and grade 3 or higher NEs occurred in 58% and 13% of patients respectively. Sixty-eight per cent of patients did not experience CRS or NEs within 72 h of axi-cel. With a median follow-up of 8·9 months, objective and complete response rates were 95% and 80% respectively. Overall, prophylactic corticosteroids and earlier corticosteroid and/or tocilizumab intervention resulted in no grade 3 or higher CRS, a low rate of grade 3 or higher NEs and high response rates in this study population.
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Keywords: axi-cel, chimaeric antigen receptor-T cell, corticosteroids, cytokine release syndrome, large B-cell lymphoma, prophylaxis, Hematology
ISSN: 0007-1048
Publisher: Wiley-Blackwell
Note: Funding Information: : consultancy or advisory role for Kite, a Gilead Company, Pfizer, Spectrum Pharmaceuticals, Legend, and Bayer. : honoraria from Kite, a Gilead Company, Takeda, Roche, and Celgene; consultancy or advisory role for Kite, a Gilead Company, Takeda, Roche, and Sandoz; travel support from Roche. : honoraria from Kyowa and Seattle Genetics; consultancy or advisory role for Pharmacyclics, Bayer, Kite, a Gilead Company, Pfizer, Janssen, Juno/Celgene, Bristol‐Myers Squibb, Kyowa, Alexion, Fosun Kite, Innovent, Seattle Genetics, and BeiGene; speakers’ bureau participation for Kite, a Gilead Company, Kyowa, Bayer, Pharmacyclics/Janssen, Seattle Genetics, Acrotech/Aurobindo, BeiGene, Verastem, AstraZeneca, Juno/Celgene/Bristol Myers Squibb, Genentech/Roche, and AbbVie; research funding from Bayer, Kite, a Gilead Company, Juno/Celgene/Bristol‐Myers Squibb, Merck, Portola, Incyte, Genentech, Pharmacyclics, Seattle Genetics, Janssen, and Millennium. : honoraria from Gilead Sciences, AbbVie, and Janssen; 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research funding from Kite, a Gilead Company, Janssen, Celgene, Bluebird Bio, Merck, and Takeda. : consultancy or advisory role for Janssen and Kite, a Gilead Company. : employment with Colorado Blood Cancer Institute Medical Group; consultancy or advisory role for, speakers' bureau participation for, and research funding from Kite, a Gilead Company. : employment with Regional Cancer Care Associates/OMI; leadership role at and stock or other ownership in Cancer Outcome Tracking Analysis (COTA); consultancy or advisory role for AstraZeneca, Celgene, Gilead Sciences, Kite, a Gilead Company, and Xcenda; research funding from Acerta, AstraZeneca, Celgene, Constellation, Genentech‐Hoffmann La Roche, Infinity, and Infinity Verastem. : honoraria from, consultancy or advisory role for, and travel support from Kite, a Gilead Company, Novartis, and Miltenyi; research funding from Roche, Takeda, and Celgene. : honoraria from Kite, a Gilead Company, Celgene, Novartis, Pfizer, Precision Biosciences, Nkarta, Lonza, and AbbVie; 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researching funding from Kite, a Gilead Company, Incyte, Amgen, Gamida Cell, Macrogenics, Cellectar, and Bristol‐Myers Squibb. : no relevant financial relationships to disclose. : consultancy or advisory role for Partner, Takeda, EUSA, Kite, a Gilead Company, Kyowa Kirin, and Magenta; speakers' bureau participation for Takeda and Kite, a Gilead Company; research funding from Bristol‐Myers Squibb, Kite, a Gilead Company, Genentech, Incyte, and Fate. and : employment with Kite, a Gilead Company; stock or other ownership in Gilead Sciences. : employment with Kite, a Gilead Company; stock or other ownership in OmniacPharmConsult Ltd. former employment with Kite, a Gilead Company. : employment with Kite, a Gilead Company, and Trillium Therapeutics; stock or other ownership in and patents, royalties, or other intellectual property from Trillium Therapeutics. : honoraria from Celgene; consultancy or advisory role for Kite, a Gilead Company. OOO KB JM SdG JMV NLB YL AD PAM AHG MJK CAJ UF MCM CT JMT PS IA DT JJK, JM, YZ, LG ZB JMR: LJ TvM Publisher Copyright: © 2021 Kite, a Gilead Company. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.
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