Cancer research and treatment · 2025
Effectiveness of CAR-T Cell Therapies for Relapsed/Refractory Follicular Lymphoma: An External Control Arm Study.
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Seo Hee-Jin, Kim Ju Hwan, Yoon Sang Eun, Kim Won Seog, Yon Dong Keon, Shin Ju-Young, Kim Seok Jin
Аннотация
PURPOSE: Axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), and lisocabactagene maraleucel (liso-cel) have received regulatory approval for relapsed or refractory follicular lymphoma (r/r FL). However, the data are scare on their comparative effectiveness against the salvage therapies available in real-world settings. This study aimed to indirectly compare treatment outcomes of axi-cel, tisa-cel, and liso-cel versus usual care in South Korean patients with FL.
MATERIALS AND METHODS: To assess effectiveness in real-world data, aggregate data from the ZUMA-5, ELARA, and TRANSCEND FL studies were compared with individual patient data from the Samsung Medical Center - Lymphoma Cohort Study (SMC-LCS). Patients meeting ZUMA-5, ELARA, and TRANSCEND FL eligibility criteria were selected as the external control arm. All eligible treatment lines per patient were analyzed as independent episodes and weighted using the matching-adjusted indirect comparison (MAIC) method. Time-to-event outcomes were assessed with weighted Kaplan-Meier analysis, and adjusted hazard ratios (aHR) were estimated using Cox proportional hazards models.
RESULTS: Axi-cel included 127 patients, tisa-cel included 94, liso-cel included 101, and 121 episodes from 49 patients were analyzed in the external control arm. The weighted hazard ratios for overall survival (OS) and progression-free survival (PFS) for axi-cel versus the external control were 0.37 (95% CI, 0.21-0.64), 0.35 (95% CI, 0.20-0.59), respectively. For tisa-cel, the HRs were 0.24 (95% CI, 0.11-0.53), and 0.35 (95% CI, 0.20-0.60), respectively. For liso-cel, the HRs were 0.38 (95% CI, 0.13-1.04), and 0.36 (95% CI, 0.15-0.88), respectively.
CONCLUSION: All three CAR-T therapies showed outstanding effectiveness compared to conventional treatments in usual care in South Korea.
MATERIALS AND METHODS: To assess effectiveness in real-world data, aggregate data from the ZUMA-5, ELARA, and TRANSCEND FL studies were compared with individual patient data from the Samsung Medical Center - Lymphoma Cohort Study (SMC-LCS). Patients meeting ZUMA-5, ELARA, and TRANSCEND FL eligibility criteria were selected as the external control arm. All eligible treatment lines per patient were analyzed as independent episodes and weighted using the matching-adjusted indirect comparison (MAIC) method. Time-to-event outcomes were assessed with weighted Kaplan-Meier analysis, and adjusted hazard ratios (aHR) were estimated using Cox proportional hazards models.
RESULTS: Axi-cel included 127 patients, tisa-cel included 94, liso-cel included 101, and 121 episodes from 49 patients were analyzed in the external control arm. The weighted hazard ratios for overall survival (OS) and progression-free survival (PFS) for axi-cel versus the external control were 0.37 (95% CI, 0.21-0.64), 0.35 (95% CI, 0.20-0.59), respectively. For tisa-cel, the HRs were 0.24 (95% CI, 0.11-0.53), and 0.35 (95% CI, 0.20-0.60), respectively. For liso-cel, the HRs were 0.38 (95% CI, 0.13-1.04), and 0.36 (95% CI, 0.15-0.88), respectively.
CONCLUSION: All three CAR-T therapies showed outstanding effectiveness compared to conventional treatments in usual care in South Korea.