PMID- 37572232
OWN - NLM
STAT- Publisher
LR  - 20231010
IS  - 1573-0646 (Electronic)
IS  - 0167-6997 (Print)
IS  - 0167-6997 (Linking)
VI  - 41
IP  - 5
DP  - 2023 Oct
TI  - Efficacy, safety, and cost-minimization analysis of axicabtagene ciloleucel and 
      tisagenlecleucel CAR T-Cell therapies for treatment of relapsed or refractory 
      follicular lymphoma.
PG  - 710-718
LID - 10.1007/s10637-023-01389-w [doi]
AB  - Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are chimeric 
      antigen receptor (CAR) T-cell therapies used to treat adult patients with 
      relapsed or refractory follicular lymphoma (rrFL) after two or more lines of 
      systemic therapy. In the absence of head-to-head clinical trials, this study 
      aimed to compare the efficacy, safety, and cost of axi-cel and tisa-cel in the 
      treatment of rrFL after at least two lines of treatment. Overall response rate 
      (ORR) and safety signals were compared using reporting odds ratios (RORs) with 
      95% confidence intervals (CIs) at p < 0.05. Progression-free survival (PFS), 
      duration of response (DoR), and overall survival (OS) were compared using the 
      Kaplan?Meier method with a log-rank test. Cost and cost-minimization analyses of 
      drug acquisition, drug administration, serious adverse events (AEs), and relapsed 
      management were calculated. Costs were extracted from the IBM-Micromedex Red 
      Book, Centers for Medicare and Medicaid Services, and existing literature. 
      Statistical analyses were conducted using Microsoft Excel and R version 4.0.5. No 
      statistically significant differences were observed between axi-cel and tisa-cel 
      in terms of ORR, DoR, and OS (p > 0.05). PFS was significantly better with 
      tisa-cel (p < 0.05). Axi-cel was significantly associated with higher incidences 
      of CRS, neurologic events, and grade 3-4 AEs than tisa-cel (ROR > 1, p < 0.05). 
      Axi-cel and tisa-cel cost $512,021 and $450,885 per patient, respectively, 
      resulting in savings of US$61,136 with tisa-cel over axi-cel. Tisa-cel appears to 
      have a better safety profile, fewer serious AEs, lower mortality rate, and lower 
      cost than axi-cel.
CI  - (c) 2023. The Author(s).
FAU - Ghanem, Buthainah
AU  - Ghanem B
AUID- ORCID: 0000-0003-1682-4867
AD  - Department of Pharmaceutical Economics and Policy, School of Pharmacy, Chapman 
      University, Irvine, CA, USA. bghanem@chapman.edu.
LA  - eng
PT  - Journal Article
DEP - 20230812
PL  - United States
TA  - Invest New Drugs
JT  - Investigational new drugs
JID - 8309330
SB  - IM
PMC - PMC10560186
OTO - NOTNLM
OT  - Blood cancer
OT  - CAR T cell therapy
OT  - Cancer immunotherapy
OT  - Hematology
OT  - Non-hodgkin lymphoma
COIS- Author declares no conflict of interest.
EDAT- 2023/08/13 00:42
MHDA- 2023/08/13 00:42
PMCR- 2023/08/12
CRDT- 2023/08/12 11:08
PHST- 2023/05/05 00:00 [received]
PHST- 2023/08/02 00:00 [accepted]
PHST- 2023/08/13 00:42 [pubmed]
PHST- 2023/08/13 00:42 [medline]
PHST- 2023/08/12 11:08 [entrez]
PHST- 2023/08/12 00:00 [pmc-release]
AID - 10.1007/s10637-023-01389-w [pii]
AID - 1389 [pii]
AID - 10.1007/s10637-023-01389-w [doi]
PST - ppublish
SO  - Invest New Drugs. 2023 Oct;41(5):710-718. doi: 10.1007/s10637-023-01389-w. Epub 
      2023 Aug 12.