Open Access

Table 2

Two approved CAR-T therapies using SAT/ECA studies for relapsed or refractory diffuse large B-cell lymphoma with ≥2 prior lines of therapy.

Axicabtagene ciloleucel Tisagenlecleucel
SAT ZUMA-1 study (n = 101) [6] JULIET study (n = 115) [7]
Almost 2 dozen of medical centers in U.S. and Israel. Over a dozen of medical centers from U.S. and other countries.
ECA SCHOLAR-1 study (n = 636) [8] CORAL study (n = 297) [9]
Observational cohorts from two large medical centers and participants of two previous phase-III RCTs. Observational cohorts from the Lymphoma Academic Research Organization (LYSARC) in France.
Key endpoints Complete response, overall response, progression events, and overall survival.
Bias mitigation Multivariable regression including propensity score analysis.
Sensitivity analysis of definition of SoC.

Residual confounding biases

Patient-level Unable to control time trends due to use of a historical ECA.
Concern over unobserved confounders.
Non-random missingness in ECAs.
System-level Unable to adjust because of use of the post-intervention measurement only design.

CAR-T: chimeric antigen receptor T-cell; SAT: single arm trial; ECA: external control arm; SoC: standard-of-care.

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