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Page 4 of 14 Haydu et al. J Cancer Metastasis Treat 2021;7:36 https://dx.doi.org/10.20517/2394-4722.2021.39

Table 1. Summary of anti-CD19 CAR T-cell products approved and under investigation in B-cell lymphomas
Additional histologies
Lymphoma FDA-approved Highlighted ongoing studies
included in pivotal trials
Large B-cell
(R/R)
[10] [37]
DLBCL Axi-cel (ZUMA-1) 1st line (high-risk): Axi-cel (ZUMA-12)
Tisa-cel (JULIET) [11] 2nd line: Axi-cel (ZUMA-7) [35] , Tisa-cel (BELINDA) [36] , Liso-cel
[9]
Liso-cel (TRANSCEND) (TRANSFORM)
[54]
CAR T plus (R/R): Axi-cel (ZUMA-6; atezolizumab) , Tisa-cel
(PORTIA; pembrolizumab) [55] , Tisa-cel (NCT03876028; ibrutinib),
Liso-cel (PLATFORM; durvalumab, CC-122/220)
Allogeneic CAR (R/R): ALLO-501A (ALPHA-2), CAR-NK
[62]
(NCT03056339)
HGBCL Axi-cel (ZUMA-1) [10]
[11]
Tisa-cel (JULIET)
Liso-cel (TRANSCEND) [9]
[10]
PMBCL Axi-cel (ZUMA-1)
Liso-cel (TRANSCEND) [9]
Transformed
[10]
FL Axi-cel (ZUMA-1)
[11]
Tisa-cel (JULIET)
[9]
Liso-cel (TRANSCEND)
MZL Liso-cel (TRANSCEND) [9]
[9]
CLL/SLL Liso-cel (TRANSCEND)
Overall Axi-cel (ZUMA-1) [10,18]
ORR = 82%, CRR = 58%
Tisa-cel (JULIET) [11]
ORR = 52%, CRR = 40%
[9]
Liso-cel (TRANSCEND)
ORR = 73%, CRR = 53%
[12] [25]
MCL (R/R) Brexu-cel (ZUMA-2) Liso-cel (TRANSCEND)
ORR = 93%, CRR = 67% ORR = 84%, CRR = 59%
[13] [39]
FL (R/R) Axi-cel (ZUMA-5) Tisa-cel (Elara)
ORR = 94%, CRR = 80% ORR = 83%, 65%
[9]
FL Grade 3B Liso-cel (TRANSCEND)
MZL (R/R) Axi-cel (ZUMA-5) [13]
ORR = 85%, CRR = 60%
CLL/SLL Liso-cel (TRANSCEND) [43]
(R/R) ORR = 82%, CRR = 45%
CAR T plus BTKi: Liso-cel (PLATFORM; TRANSCEND [59] ), CD19 CAR
[58]
(NCT01865617)
PCNSL Tisa-cel (NCT04134117), City of Hope [53]
DLBCL: Diffuse large B-cell lymphoma; R/R: relapsed/refractory; HGBCL: high-grade B-cell lymphoma; PMBC: primary mediastinal B-cell
lymphoma; FL: follicular lymphoma; MZL: marginal zone lymphoma; CLL: chronic lymphocytic leukemia; SLL: small lymphocytic leukemia; MCL:
mantle cell lymphoma; PCNSL: primary CNS lymphoma; ORR: objective/overall response rate; CRR: complete response rate; SOC: standard of
care.
meet the requirements to be considered liso-cel). Product could not be manufactured for 2 patients and 48
patients had lymphoma complications or died before infusion, reflecting the high-risk nature of this
population. Ultimately 256 patients were included in the efficacy-evaluable set. The ORR was 73%, with a
CR rate of 53% and an estimated PFS and OS at 1 year of 44% and 58%, respectively, for the entire
population. Among complete responders, 86% were alive at 1 year. Liso-cel is the only CAR T-cell product
for large B-cell lymphomas that was studied in certain high-risk patient populations including patients with
secondary CNS disease, prior allogeneic stem cell transplant, ECOG performance status of 2, and in certain
histologies such as DLBCL transformed from indolent lymphomas other than FL (CLL, marginal zone,
Waldenstroms) and grade 3B FL, which is thus reflected in the broader range of eligible histologies included
in the FDA label.