Table 3.

CAR T-cell therapies FDA approved for AYA B-ALL

TrialNo. of patientsMedian age (range), yearsCR/CRi (%)MRD-negativeCR in responders (%)Median RFS (mo)Median OS (mo)Unique toxicity
Tisa-cel        
 ELIANA26  75 11 (3-23) 81 100 EFS at 12 months = 50% 19.1 CRS (any): 77%
Gr. ≥3: 35%
ICANS (any): 40%
Grade ≥3: 13% 
Brexu-cel        
 ZUMA-3, phase 1/228  78 42.5 (18-84) 73 97 11.7 25.4 CRS (any): 93%
Gr. ≥3: 31%
ICANS (any): 78%
Gr. ≥3: 38% 
TrialNo. of patientsMedian age (range), yearsCR/CRi (%)MRD-negativeCR in responders (%)Median RFS (mo)Median OS (mo)Unique toxicity
Tisa-cel        
 ELIANA26  75 11 (3-23) 81 100 EFS at 12 months = 50% 19.1 CRS (any): 77%
Gr. ≥3: 35%
ICANS (any): 40%
Grade ≥3: 13% 
Brexu-cel        
 ZUMA-3, phase 1/228  78 42.5 (18-84) 73 97 11.7 25.4 CRS (any): 93%
Gr. ≥3: 31%
ICANS (any): 78%
Gr. ≥3: 38% 

CRi, complete remission with incomplete count recovery; CRS, cytokine release syndrome; Gr, grade, ICANS, immune effector cell-associated neurotoxicity syndrome.

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