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:Tisagenlecleucel: CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma.
Tisagenlecleucel: CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma.
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Tisa-cel 对经过多线治疗的复发/难治性 FL 是一种高效疗法,其毒性为低级别且可控。
引言:Tisagenlecleucel(tisa-cel)是一种抗 CD19 CAR-T 疗法,已在复发/难治性(R/R)大 B 细胞淋巴瘤和 R/R B 急性淋巴细胞白血病中显示临床活性。该疗法在 R/R 滤泡性淋巴瘤(FL)中疗效尤其显著,且毒性特征可控。针对 R/R FL 开展的关键性 ELARA 研究证实了这些发现,并促使 FDA 批准 tisa-cel 用于既往接受过两线全身治疗的 R/R FL。综述内容:本文首先介绍 FL 及当前治疗格局,重点讨论 R/R 疾病;随后综述 CAR-T 在 R/R FL 中的作用,并聚焦当前可用产品;接着概述 ELARA 研究,以说明接受治疗的患者群体;最后讨论产品选择相关问题,以及在疗效相近的情况下双特异性抗体是否会挑战 CAR-T 在 FL 治疗中的地位。专家观点:tisa-cel 对经多线治疗的 R/R FL 疗效显著,毒性多为低级别且可控。关键性 ELARA 研究显示,包括高危患者在内的患者可获得持久缓解。临床医生应考虑尽早转诊 R/R FL 患者,以评估治疗适用性并讨论治疗选择。
INTRODUCTION: Tisagenlecleucel (tisa-cel) is an anti CD19 CAR-T therapy that has demonstrated clinical activity in R/R large B-cell lymphoma and R/R B-cell acute lymphoblastic leukemia. It showed particularly high efficacy in R/R follicular lymphoma (FL) with a manageable toxicity profile. The pivotal ELARA study in R/R FL confirmed these findings and led to the FDA approval of tisa-cel in R/R FL after two lines of systemic therapies. AREAS COVERED: We start with an introduction of FL and the current treatment landscape with emphasis on the R/R setting.
We review the role of CAR-T in R/R FL with focus on currently available products.
We describe the ELARA study at a high level to give a perspective of the patient population that was treated.
Finally, we discuss aspects related to product selection and whether bispecific antibodies will challenge the role of CAR-T in FL given their similar efficacy. EXPERT OPINION: Tisa-cel is a highly effective therapy for heavily pretreated R/R FL with a toxicity profile that is low grade and manageable. Durable remissions (including high-risk patients) are seen in the pivotal ELARA study. Clinicians should consider early referral of R/R FL patients for assessment and discussion.
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