Tisagenlecleucel and axicabtagene ciloleucel CAR T cell therapy for relapsed/refractory follicular lymphoma: a retrospective observational study utilizing external control arm
Axicabtagene ciloleucel(axi-cel) and tisagenlecleucel(tisa-cel) are effective treatments for relapsed or refractory follicular lymphoma(r/r FL), as demonstrated in the studies comparing these treatments vs. conventional therapies. The two single-arm trials, ZUMA5 and ELARA, share similar patient eligibility criteria, which is crucial when selecting an external control arm. This study aims to assess comparative effectiveness of axi-cel and tisa-cel by comparing OS, PFS and TTNT with an external control arm from SMC-LCS(Samsung Medical Center - Lymphoma Cohort Study). Eligibility criteria of ZUMA5 and ELARA was applied to construct the external control arm from SMC-LCS. These patients were then weighted using matching adjusted indirect comparison(MAIC) method to resemble baseline characteristics of ZUMA5 and ELARA, respectively. Time-to-event outcomes analyzed with weighted Kaplan-Meier. OS, PFS and TTNT in the external control arm were 31.5, 16.8, and 6.8 months while outcomes were not reached in the axi-cel and tisa-cel arms. In the analysis of ZUMA5 vs. external control arm, the hazard ratios(HRs) for OS, PFS, and TTNT were 0.98(95% CI, 0.51-1.89), 0.60(0.35-1.03), and 0.31(0.18-0.52). For ELARA vs. external control arm, the HRs were 0.47(0.21-1.06), 0.78(0.46-1.31), and 0.34(0.20-0.58). Axi-cel and tisa-cel both demonstrated outstanding effectiveness compared to patients with r/r FL receiving conventional therapies in a routine care setting in South Korea.
2024 Spring Convention