British Journal of Haematology
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 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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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; and van Meerten, Tom, "Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma" (2021). Journal Articles: Internal Medicine. 22.