肿瘤细胞治疗研究
英文原题：Lisocabtagene maraleucel in patients with relapsed or refractory marginal zone lymphoma (TRANSCEND FL): primary analysis results from the global, multicohort, single-arm, phase 2 study.
Lisocabtagene maraleucel in patients with relapsed or refractory marginal zone lymphoma (TRANSCEND FL): primary analysis results from the global, multicohort, single-arm, phase 2 study.
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在复发/难治性 MZL 患者中，lisocabtagene maraleucel 显示出高比例的持久缓解。
**背景：**复发/难治性边缘区淋巴瘤（MZL）仍缺乏可诱导深度且持久应答的有效治疗。TRANSCEND FL的MZL队列主要分析旨在评估CD19靶向嵌合抗原受体（CAR）T细胞疗法利索卡布他基因马拉赛的疗效和安全性。 **方法：**该2期、单臂、多队列研究在美国、加拿大、欧洲和日本30个中心开展。既往接受至少两线全身治疗的复发/难治性MZL患者可入组，接受1×10^8个CAR阳性T细胞的利索卡布他基因马拉赛；允许桥接治疗。主要终点为独立审查委员会按2014年Lugano标准通过CT评估的总体缓解率（原假设50%）。试验注册号NCT04245839，仍在进行。 **结果：**2020年11月11日至2023年8月24日招募的77例白细胞单采患者中，67例接受利索卡布他基因马拉赛，66例可评估疗效。MZL亚型包括淋巴结型32例（48%）、脾型18例（27%）和结外黏膜相关淋巴组织型17例（25%）。既往全身治疗线数中位数（四分位距）为3（2–4），研究中位随访24.1个月。主要终点达成，总体缓解率为95%（n=63；95% CI 87.3–99.1；单侧P<0.0001）。所有患者均发生治疗相关不良事件。3例（各占4%）发生3级细胞因子释放综合征或神经系统事件；未发生4–5级事件。11例（16%）出现3级感染：6例（9%）发生在治疗期间90天内，7例（10%）发生在治疗期之后。 **解读：**复发/难治性MZL患者接受利索卡布他基因马拉赛后缓解率高且持久，安全性可管理，未出现新的安全信号。结果支持将该疗法作为复发/难治性MZL的新治疗选择。 **经费来源：**Celgene（百时美施贵宝公司）。
Effective treatments with deep and durable responses for relapsed or refractory marginal zone lymphoma (MZL) are lacking. The objective of the primary analysis from the MZL cohort of TRANSCEND FL was to evaluate the efficacy and safety of the CD19-directed chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel.
In this phase 2, single-arm, multicohort study, patients from 30 sites in the USA, Canada, Europe, and Japan with relapsed or refractory MZL who had at least two previous lines of systemic therapy were eligible to receive lisocabtagene maraleucel (100 10 6 CAR + T cells). Bridging therapy was allowed. The primary endpoint was overall response rate per independent review committee by CT by use of Lugano 2014 criteria (null hypothesis 50%). This study is registered with ClinicalTrials.gov, NCT04245839, and is ongoing.
Of 77 leukapheresed patients recruited between November 11, 2020, and August 24, 2023, 67 received lisocabtagene maraleucel and 66 were efficacy evaluable. MZL subtypes included nodal (n=32 [48%]), splenic (n=18 [27%]), and extranodal-mucosa-associated lymphoid tissue (n=17 [25%]). Median (IQR) previous lines of systemic therapy was 3 (2-4). Median on-study follow-up was 24 1 months. The primary endpoint was met, with an overall response rate of 95% (n=63; 95% CI, 87 3-99 1; one-sided p<0 0001). All patients experienced a treatment-related adverse event. Grade 3 cytokine release syndrome or neurological events occurred in three (4%) patients each (no grade 4-5 events). 11 (16%) patients had grade 3 infections: six (9%) patients during the 90-day treatment-emergent period and seven (10%) during the post-treatment-emergent period. INTERPRETATION: In patients with relapsed or refractory MZL, lisocabtagene maraleucel showed high rates of durable responses. The safety profile was manageable, with no new safety signals. These results support lisocabtagene maraleucel as a new treatment option for patients with relapsed or refractory MZL. FUNDING: Celgene, a Bristol-Myers Squibb Company.
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