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:Survival Benefit of Relmacabtagene Autoleucel Versus Usual Care in Relapsed/Refractory Follicular Lymphoma: A Matching-Adjusted Indirect Analysis.
Survival Benefit of Relmacabtagene Autoleucel Versus Usual Care in Relapsed/Refractory Follicular Lymphoma: A Matching-Adjusted Indirect Analysis.
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在当前复发/难治性(R/R)滤泡性淋巴瘤(FL)治疗格局中,瑞基奥仑赛(relmacabtagene autoleucel,relma-cel)的生存获益尚不清楚。
本研究在一项回顾性、观察性、大规模真实世界研究(RWS)中,比较中国 FL 患者在 RELIANCE 试验(NCT04089215)接受 relma-cel 与接受常规治疗的生存结局。研究对中国 RELIANCE 试验中的 27 例患者和 RWS 中的 53 例患者进行了间接治疗比较。
此外,还与评估海外现有治疗选择的 SCHOLAR-5 研究进行直接比较。倾向评分匹配后,relma-cel 组的疾病状态(FLIPI2 评分、组织学分级、复发状态、24 个月内进展[POD24])似乎比常规治疗组更严重。尽管如此,relma-cel 组的 PFS 中位数尚未达到(95% CI 8.97–未达到),常规治疗组为 19.98 个月(95% CI 16.03–28.98),风险比(HR)为 0.40(95% CI 0.13–1.23)。
此外,比较 RELIANCE 与 SCHOLAR-5 并采用海外现有治疗方案的分析显示,PFS 的 HR 为 0.20(95% CI 0.07–0.58)。24 个月时,relma-cel 输注后患者生存率为 100%;中国常规治疗后为 38.2%,SCHOLAR-5 常规治疗后为 62.7%。对接受过两线治疗的 R/R FL 患者而言,与当前常规疗法相比,relma-cel 显示出更优的生存获益。
Little is known about the survival benefit of relmacabtagene autoleucel (relma-cel) in the current therapeutic landscape of relapsed/refractory (r/r) follicular lymphoma (FL). The current study compared the survival outcomes of Chinese FL patients administered relma-cel in RELIANCE (NCT04089215) and usual care in a retrospective, observational, large-scale real-world study (RWS). An indirect treatment comparison was carried out for 27 patients from RELIANCE and 53 patients from the RWS in China.
Additionally, a direct comparison was made with the SCHOLAR-5 study, which assessed available treatment options abroad. After propensity score matching, disease status (FLIPI2 score, histological grade, relapse status, POD24) in the relma-cel group appeared to indicate more severe disease versus the usual care group. Nevertheless, median progression-free survival (PFS) was not reached (95% CI 8. 97-NR) for relma-cel versus 19. 98 months (95% CI 16. 03-28. 98) for usual care, indicating a hazard ratio (HR) of 0.
40 (95% CI 0. 13-1. 23). Besides, a comparative analysis of RELIANCE and SCHOLAR-5, applying available treatment options abroad, revealed an HR for PFS of 0. 20 (95% CI 0. 07-0. 58). At 24 months, 100% of patients survived after relma-cel infusion, versus 38. 2% after usual care in China and 62. 7% after usual care treatment in SCHOLAR-5, respectively. Relma-cel exhibits superior survival benefits versus current conventional therapies in r/r FL patients after 2 treatment lines.
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