PMID- 34493319
OWN - NLM
STAT- MEDLINE
DCOM- 20211122
LR  - 20211122
IS  - 1756-8722 (Electronic)
IS  - 1756-8722 (Linking)
VI  - 14
IP  - 1
DP  - 2021 Sep 8
TI  - Matching-adjusted indirect treatment comparison of liso-cel versus axi-cel in 
      relapsed or refractory large B cell lymphoma.
PG  - 140
LID - 10.1186/s13045-021-01144-9 [doi]
LID - 140
AB  - BACKGROUND: In the absence of randomized studies directly comparing chimeric 
      antigen receptor T cell therapies, this study used matching-adjusted indirect 
      comparisons (MAIC) to evaluate the comparative efficacy and safety of 
      lisocabtagene maraleucel (liso-cel) versus axicabtagene ciloleucel (axi-cel) in 
      patients with relapsed or refractory large B cell lymphoma (LBCL). METHODS: 
      Primary data sources included individual patient data from the TRANSCEND NHL 001 
      study (TRANSCEND [NCT02631044]; N = 256 for efficacy set, N = 269 for safety set) 
      for liso-cel and summary-level data from the ZUMA-1 study (NCT02348216; N = 101 
      for efficacy set, N = 108 for safety set) for axi-cel. Inter-study differences in 
      design, eligibility criteria, baseline characteristics, and outcomes were 
      assessed and aligned to the extent feasible. Clinically relevant prognostic 
      factors were adjusted in a stepwise fashion by ranked order. Since bridging 
      therapy was allowed in TRANSCEND but not ZUMA-1, the initial efficacy and safety 
      analyses included bridging therapy use as a matching factor (TRANSCEND patients 
      who received bridging therapy were removed). Subsequent sensitivity analyses 
      excluded this matching factor. RESULTS: The initial analysis showed similar 
      MAIC-weighted efficacy outcomes between TRANSCEND and ZUMA-1 for overall and 
      complete response rates (odds ratio [95% confidence interval (CI)], 1.40 
      [0.56-3.49] and 1.21 [0.56-2.64], respectively) and for overall survival and 
      progression-free survival (hazard ratio [95% CI], 0.81 [0.44-1.49] and 0.95 
      [0.58-1.57], respectively). MAIC-weighted safety outcomes favored liso-cel, with 
      significantly lower odds of all-grade and grade >/= 3 cytokine release syndrome 
      (odds ratio [95% CI], 0.03 [0.01-0.07] and 0.08 [0.01-0.67], respectively) and 
      study-specific neurological events (0.16 [0.08-0.33] and 0.05 [0.02-0.15], 
      respectively). Efficacy and safety outcomes remained similar in sensitivity 
      analyses, which did not include use of bridging therapy as a matching factor. 
      CONCLUSIONS: After matching and adjusting for clinically relevant prognostic 
      factors, liso-cel demonstrated comparable efficacy and a more favorable safety 
      profile compared with axi-cel in patients with third- or later-line relapsed or 
      refractory LBCL. TRIAL REGISTRATION: NCT02631044 and NCT02348216.
CI  - (c) 2021. The Author(s).
FAU - Maloney, David G
AU  - Maloney DG
AD  - Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, 
      98109-1024, USA. dmaloney@fredhutch.org.
FAU - Kuruvilla, John
AU  - Kuruvilla J
AD  - Princess Margaret Cancer Centre, Toronto, ON, Canada.
FAU - Liu, Fei Fei
AU  - Liu FF
AD  - Bristol-Myers Squibb, Princeton, NJ, USA.
FAU - Kostic, Ana
AU  - Kostic A
AD  - Bristol-Myers Squibb, Seattle, WA, USA.
FAU - Kim, Yeonhee
AU  - Kim Y
AD  - Bristol-Myers Squibb, Seattle, WA, USA.
FAU - Bonner, Ashley
AU  - Bonner A
AD  - EVERSANA, Burlington, ON, Canada.
FAU - Zhang, Yixie
AU  - Zhang Y
AD  - EVERSANA, Burlington, ON, Canada.
FAU - Fox, Christopher P
AU  - Fox CP
AD  - Nottingham University Hospitals NHS Trust, Nottingham, UK.
FAU - Cartron, Guillaume
AU  - Cartron G
AD  - Montpellier University Hospital Center, Montpellier, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT02348216
SI  - ClinicalTrials.gov/NCT02631044
PT  - Clinical Trial, Phase I
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210908
PL  - England
TA  - J Hematol Oncol
JT  - Journal of hematology & oncology
JID - 101468937
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 0 (Biological Products)
RN  - U2I8T43Y7R (axicabtagene ciloleucel)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents, Immunological/adverse effects/*therapeutic use
MH  - Biological Products/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Immunotherapy, Adoptive/adverse effects/*methods
MH  - Lymphoma, Large B-Cell, Diffuse/*therapy
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/therapy
MH  - Treatment Outcome
PMC - PMC8425084
OTO - NOTNLM
OT  - Axicabtagene ciloleucel
OT  - CAR T cell therapy
OT  - Indirect treatment comparison
OT  - Lisocabtagene maraleucel
OT  - Matching-adjusted indirect comparison
COIS- DGM has received consultancy fees for scientific advisory board membership from 
      A2 Biotherapeutics; honoraria from Amgen, BioLineRx, Bristol-Myers Squibb, 
      Celgene, a Bristol-Myers Squibb Company, Genentech, Gilead Sciences, Janssen, 
      Juno Therapeutics, a Bristol-Myers Squibb Company, Kite Pharma, a Gilead Company, 
      Legend Biotech, MorphoSys, Novartis, and Pharmacyclics; and grants for research 
      paid directly to his institution from Celgene, a Bristol-Myers Squibb Company, 
      Juno Therapeutics, a Bristol-Myers Squibb Company, and Kite Pharma, a Gilead 
      Company. He has patents with Juno Therapeutics, a Bristol-Myers Squibb Company 
      (not licensed, no royalties), and stock options in A2 Biotherapeutics. JK has 
      received consultancy fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences, 
      Karyopharm Therapeutics, Merck, Roche, and Seattle Genetics; honoraria from 
      Amgen, Antengene, AstraZeneca, Celgene, a Bristol-Myers Squibb Company, Gilead 
      Sciences, Janssen, Karyopharm Therapeutics, Merck, Novartis, Pfizer, Roche, 
      Seattle Genetics, and TG Therapeutics; and grants for research from AstraZeneca, 
      Janssen, and Roche. FFL, AK, and YK are employees of Bristol-Myers Squibb and 
      hold stock in Bristol-Myers Squibb. AB and YZ are employees of EVERSANA, which 
      received funding from Bristol-Myers Squibb to conduct the analyses. CPF has 
      received honoraria from AbbVie, Adienne, AstraZeneca, Atara Biotherapeutics, 
      Celgene, a Bristol-Myers Squibb Company, Genmab, Gilead Sciences, Incyte, Roche, 
      Sunesis Pharmaceuticals, and Takeda; and grants for research from AbbVie, 
      Adienne, Gilead Sciences, Roche, and Takeda. GC has received consultancy fees 
      from Celgene, a Bristol-Myers Squibb Company, and F. Hoffmann-La Roche and 
      honoraria from AbbVie, Celgene, a Bristol-Myers Squibb Company, F. Hoffmann-La 
      Roche, Gilead Sciences, Janssen, and Sanofi.
EDAT- 2021/09/09 06:00
MHDA- 2021/11/23 06:00
PMCR- 2021/09/08
CRDT- 2021/09/08 05:44
PHST- 2021/07/01 00:00 [received]
PHST- 2021/08/21 00:00 [accepted]
PHST- 2021/09/08 05:44 [entrez]
PHST- 2021/09/09 06:00 [pubmed]
PHST- 2021/11/23 06:00 [medline]
PHST- 2021/09/08 00:00 [pmc-release]
AID - 10.1186/s13045-021-01144-9 [pii]
AID - 1144 [pii]
AID - 10.1186/s13045-021-01144-9 [doi]
PST - epublish
SO  - J Hematol Oncol. 2021 Sep 8;14(1):140. doi: 10.1186/s13045-021-01144-9.