TY - JOUR
T1 - Patterns of Use, Outcomes, and Resource Utilization among Recipients of Commercial Axicabtagene Ciloleucel and Tisagenlecleucel for Relapsed/Refractory Aggressive B Cell Lymphomas
AU - Riedell, Peter A.
AU - Hwang, Wei Ting
AU - Nastoupil, Loretta J.
AU - Pennisi, Martina
AU - McGuirk, Joseph P.
AU - Maziarz, Richard T.
AU - Bachanova, Veronika
AU - Oluwole, Olalekan O.
AU - Brower, Jamie
AU - Flores, Oscar A.
AU - Ahmed, Nausheen
AU - Schachter, Levanto
AU - Bharucha, Kharmen
AU - Dholaria, Bhagirathbhai R.
AU - Schuster, Stephen J.
AU - Perales, Miguel Angel
AU - Bishop, Michael R.
AU - Porter, David L.
N1 - Publisher Copyright:
© 2022 The American Society for Transplantation and Cellular Therapy
PY - 2022/10
Y1 - 2022/10
N2 - Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are CD19-directed chimeric antigen receptor (CAR) T cell therapies approved for the treatment of relapsed/refractory aggressive B cell lymphomas. We present a multicenter retrospective study among centers that prescribe either commercial product to evaluate usage patterns, safety and efficacy outcomes, and resource utilization. Data collection included all patients from 8 US centers who underwent apheresis between May 1, 2018, and July 31, 2019. Patient selection, toxicity management, and disease assessment followed institutional practices. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy consensus criteria, and tumor responses were assessed according to the Lugano 2014 classification scheme. A total of 260 patients underwent apheresis, including 168 (65%) for axi-cel and 92 (35%) for tisa-cel. Among the infused patients, the median age was 59 years for axi-cel recipients and 67 years for tisa-cel recipients (P < .001). The median time from apheresis to infusion was 28 days for axi-cel recipients and 45 days for tisa-cel recipients (P < .001). Sixty-one percent of the axi-cel recipients and 43% of the tisa-cel recipients would have been ineligible for the ZUMA-1 and JULIET trials, respectively. Grade ≥3 CRS occurred in 9% of axi-cel recipients and in 1% of tisa-cel recipients (P = .017), and grade ≥3 ICANS was seen in 38% of axi-cel recipients and 1% of tisa-cel recipients (P < .001). Inpatient cell therapy infusion was common (92% in axi-cel recipients, 37% in tisa-cel recipients). The day 90 overall response rate was 52% in the axi-cel group and 41% in the tisa-cel group (P =. 113), with complete response in 44% and 35%, respectively (P =. 319). Twelve-month progression-free survival (42% versus 32%; P =. 206) and overall survival (62% versus 59%; P =. 909) rates were comparable in the axi-cel and tisa-cel groups. Baseline characteristics differed between the 2 groups, although response rates and survival outcomes were comparable, albeit lower than those in the pivotal trials. Safety and resource utilization appear to be key differentiators between axi-cel and tisa-cel.
AB - Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are CD19-directed chimeric antigen receptor (CAR) T cell therapies approved for the treatment of relapsed/refractory aggressive B cell lymphomas. We present a multicenter retrospective study among centers that prescribe either commercial product to evaluate usage patterns, safety and efficacy outcomes, and resource utilization. Data collection included all patients from 8 US centers who underwent apheresis between May 1, 2018, and July 31, 2019. Patient selection, toxicity management, and disease assessment followed institutional practices. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy consensus criteria, and tumor responses were assessed according to the Lugano 2014 classification scheme. A total of 260 patients underwent apheresis, including 168 (65%) for axi-cel and 92 (35%) for tisa-cel. Among the infused patients, the median age was 59 years for axi-cel recipients and 67 years for tisa-cel recipients (P < .001). The median time from apheresis to infusion was 28 days for axi-cel recipients and 45 days for tisa-cel recipients (P < .001). Sixty-one percent of the axi-cel recipients and 43% of the tisa-cel recipients would have been ineligible for the ZUMA-1 and JULIET trials, respectively. Grade ≥3 CRS occurred in 9% of axi-cel recipients and in 1% of tisa-cel recipients (P = .017), and grade ≥3 ICANS was seen in 38% of axi-cel recipients and 1% of tisa-cel recipients (P < .001). Inpatient cell therapy infusion was common (92% in axi-cel recipients, 37% in tisa-cel recipients). The day 90 overall response rate was 52% in the axi-cel group and 41% in the tisa-cel group (P =. 113), with complete response in 44% and 35%, respectively (P =. 319). Twelve-month progression-free survival (42% versus 32%; P =. 206) and overall survival (62% versus 59%; P =. 909) rates were comparable in the axi-cel and tisa-cel groups. Baseline characteristics differed between the 2 groups, although response rates and survival outcomes were comparable, albeit lower than those in the pivotal trials. Safety and resource utilization appear to be key differentiators between axi-cel and tisa-cel.
KW - Aggressive large B cell lymphoma
KW - CAR T cell therapy outcomes
KW - CAR T cell toxicity
KW - Chimeric antigen receptor T cell therapy
KW - Resource utilization
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UR - http://www.scopus.com/inward/citedby.url?scp=85136273493&partnerID=8YFLogxK
U2 - 10.1016/j.jtct.2022.07.011
DO - 10.1016/j.jtct.2022.07.011
M3 - Article
C2 - 35850429
AN - SCOPUS:85136273493
SN - 2666-6367
VL - 28
SP - 669
EP - 676
JO - Transplantation and Cellular Therapy
JF - Transplantation and Cellular Therapy
IS - 10
ER -