PMID- 33720336 OWN - NLM STAT- MEDLINE DCOM- 20210531 LR - 20210925 IS - 2473-9537 (Electronic) IS - 2473-9529 (Print) IS - 2473-9529 (Linking) VI - 5 IP - 6 DP - 2021 Mar 23 TI - Cytokine release syndrome and neurological event costs in lisocabtagene maraleucel-treated patients in the TRANSCEND NHL 001 trial. PG - 1695-1705 LID - 10.1182/bloodadvances.2020003531 [doi] AB - Chimeric antigen receptor (CAR) T-cell therapies have demonstrated high response rates in patients with relapsed/refractory large B-cell lymphoma (LBCL); however, these therapies are associated with 2 CAR T cell-specific potentially severe adverse events (AEs): cytokine release syndrome (CRS) and neurological events (NEs). This study estimated the management costs associated with CRS/NEs among patients with relapsed/refractory LBCL using data from the pivotal TRANSCEND NHL 001 trial of lisocabtagene maraleucel, an investigational CD19-directed defined composition CAR T-cell product with a 4-1BB costimulation domain administered at equal target doses of CD8+ and CD4+ CAR+ T cells. This retrospective analysis of patients from TRANSCEND with prospectively identified CRS and/or NE episodes examined relevant trial-observed health care resource utilization (HCRU) associated with toxicity management based on the severity of the event from the health care system perspective. Cost estimates for this analysis were taken from publicly available databases and published literature. Of 268 treated patients as of April 2019, 127 (47.4%) experienced all-grade CRS and/or NEs, which were predominantly grade /=3 CRS and NE). Key drivers of cost were facility expenses, including intensive care unit and other inpatient hospitalization lengths of stay. HCRU and costs were significantly greater among patients with grade >/=3 AEs (22.8%). Therefore, CAR T-cell therapies with a low incidence of severe CRS/NEs will likely reduce HCRU and costs associated with managing patients receiving CAR T-cell therapy. This clinical trial was registered at www.clinicaltrials.gov as #NCT02631044. CI - (c) 2021 by The American Society of Hematology. FAU - Abramson, Jeremy S AU - Abramson JS AD - Massachusetts General Hospital Cancer Center, Boston, MA. FAU - Siddiqi, Tanya AU - Siddiqi T AD - City of Hope National Medical Center, Duarte, CA. FAU - Garcia, Jacob AU - Garcia J AD - Bristol-Myers Squibb, Seattle, WA. FAU - Dehner, Christine AU - Dehner C AD - Bristol-Myers Squibb, Seattle, WA. FAU - Kim, Yeonhee AU - Kim Y AD - Bristol-Myers Squibb, Seattle, WA. FAU - Nguyen, Andy AU - Nguyen A AD - BluePath Solutions, Los Angeles, CA; and. FAU - Snyder, Sophie AU - Snyder S AD - BluePath Solutions, Los Angeles, CA; and. FAU - McGarvey, November AU - McGarvey N AD - BluePath Solutions, Los Angeles, CA; and. FAU - Gitlin, Matthew AU - Gitlin M AD - BluePath Solutions, Los Angeles, CA; and. FAU - Pelletier, Corey AU - Pelletier C AD - Bristol-Myers Squibb, Princeton, NJ. FAU - Jun, Monika P AU - Jun MP AD - Bristol-Myers Squibb, Princeton, NJ. LA - eng SI - ClinicalTrials.gov/NCT02631044 PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - Blood Adv JT - Blood advances JID - 101698425 RN - 0 (Antigens, CD19) SB - IM MH - Antigens, CD19 MH - *Cytokine Release Syndrome MH - Humans MH - Immunotherapy, Adoptive MH - *Lymphoma, Large B-Cell, Diffuse MH - Retrospective Studies PMC - PMC7993105 COIS- Conflict-of-interest disclosure: J.S.A. declares consulting for Allogene, Bristol-Myers Squibb, Celgene, Gilead, Kite Pharma, and Novartis. T.S. declares consulting for AstraZeneca, BeiGene, Celgene, Juno Therapeutics, Kite Pharma, and Pharmacyclics/AbbVie; institutional research funding from AstraZeneca, BeiGene, Celgene, Juno Therapeutics, Kite Pharma, Oncternal, Pharmacyclics, and TG Therapeutics; speakers bureau for AstraZeneca, Janssen, Pharmacyclics, and Seattle Genetics; and travel, accommodations, and expenses from AstraZeneca. J.G., C.D., C.P., M.P.J., and Y.K. are employees of Bristol-Myers Squibb and may own stock in Bristol-Myers Squibb. S.S., A.N., N.M., and M.G. are employees of BluePath Solutions, which was contracted by Bristol-Myers Squibb to perform the analyses. EDAT- 2021/03/16 06:00 MHDA- 2021/06/01 06:00 PMCR- 2021/03/15 CRDT- 2021/03/15 13:16 PHST- 2020/10/06 00:00 [received] PHST- 2021/02/09 00:00 [accepted] PHST- 2021/03/15 13:16 [entrez] PHST- 2021/03/16 06:00 [pubmed] PHST- 2021/06/01 06:00 [medline] PHST- 2021/03/15 00:00 [pmc-release] AID - S2473-9529(21)00194-4 [pii] AID - 2020/ADV2020003531 [pii] AID - 10.1182/bloodadvances.2020003531 [doi] PST - ppublish SO - Blood Adv. 2021 Mar 23;5(6):1695-1705. doi: 10.1182/bloodadvances.2020003531.