不适合移植的大 B 细胞淋巴瘤二线使用 axicabtagene ciloleucel:ALYCANTE 最终分析
Second-line axicabtagene ciloleucel in large B-cell lymphoma ineligible for transplantation: ALYCANTE final analysis.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Comparative efficacy of tisagenlecleucel and lisocabtagene maraleucel among adults with relapsed/refractory large B-cell lymphomas: an indirect treatment comparison.
Comparative efficacy of tisagenlecleucel and lisocabtagene maraleucel among adults with relapsed/refractory large B-cell lymphomas: an indirect treatment comparison.
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本研究比较了tisagenlecleucel(tisa-cel)与lisocabtagene maraleucel(liso-cel)在复发/难治性大B细胞淋巴瘤(r/r LBCL)中的总生存期(OS)、无进展生存期(PFS)、完全缓解率(CRR)和总缓解率(ORR)。采用匹配调整间接比较(MAIC),将JULIET研究(tisa-cel)的个体患者水平数据进行加权,以匹配TRANSCEND研究(liso-cel)的患者人群。主要分析比较了JULIET研究中接受输注的患者(N = 106)与TRANSCEND研究的疗效可评估集(EES)(N = 256[接受输注])。经调整后,tisa-cel与liso-cel EES患者之间的OS、PFS和CRR具有可比性。tisa-cel的估计调整后2年OS、2年PFS、ORR和CRR分别为45.6%、38.2%、62.9%和47.7%,而liso-cel分别为43.8%、42.1%、72.7%和53.1%。一项情景分析将JULIET患者与TRANSCEND主要分析集(PAS)(N = 133)进行了比较。TRANSCEND PAS的ORR显著高于匹配后的JULIET患者,但未观察到CRR的显著差异。
This study compared overall survival (OS), progression-free survival (PFS), complete response rate (CRR), and overall response rate (ORR) of tisagenlecleucel (tisa-cel) and lisocabtagene maraleucel (liso-cel) in relapsed or refractory large B-cell lymphomas (r/r LBCL). Using matching-adjusted indirect comparison (MAIC), individual patient-level data from JULIET (tisa-cel) were weighted to match the patient population in TRANSCEND (liso-cel). The main analysis compared infused JULIET patients ( N = 106) with the TRANSCEND efficacy-evaluable set (EES) ( N = 256 [infused]).
After adjustment, OS, PFS, and the CRR were comparable between tisa-cel and liso-cel EES patients. The estimated adjusted 2-year OS, 2-year PFS, ORR, and CRR were 45. 6, 38. 2, 62. 9, and 47. 7%, respectively, for tisa-cel vs. 43. 8, 42. 1, 72. 7, and 53. 1% for liso-cel. A scenario analysis compared JULIET patients to the TRANSCEND primary analysis set (PAS) ( N = 133). ORR was significantly higher in the TRANSCEND PAS compared with matched JULIET patients, but no significant differences in CRR were observed.
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