Long-term remission and survival in patients with relapsed or refractory multiple myeloma after treatment of LCAR-B38M CAR-T: At least 5-year follow-up in LEGEND-2.

作者：Jian‐Qing Mi, Wanhong Zhao, Lijuan Chen, Weijun Fu, Baiyan Wang, Jie Xu, Jie Liu, Shiwei Jin, Han Zhu, Juan Du, Hua Jiang, Huabin Sun, Yehui Jia, Xiao-Hu Fan, Jianyong Li, Jian Hou, Chen Zhu, Wanggang Zhang, Aili He, Sai‐Juan Chen · 发表于：Journal of Clinical Oncology · 年份：2023 · DOI：10.1200/jco.2023.41.16_suppl.8010 · 被引用次数：8 · 研究领域：CAR-T cell therapy research、Biosimilars and Bioanalytical Methods

8010 Background: LCAR-B38M CAR-T cells express a structurally differentiated CAR construct containing a 4-1BB costimulatory domain and 2 BCMA-targeting single-domain antibodies designed to confer avidity. LEGEND-2 was a first-in-human phase 1 study of LCAR-B38M conducted in China, which showed encouraging efficacy and manageable safety in 74 patients (pts) with RRMM. The US phase 1b/2 CARTITUDE-1 and Chinese phase 2 CARTIFAN-1 trials of ciltacabtagene autoleucel, which expresses the same CAR as LCAR-B38M, confirmed the efficacy observed in LEGEND-2. Here, we present ≥5-y FU data from LEGEND-2, the longest FU for any BCMA-targeted CAR-T cell therapy study. Methods: Study design was previously published. Pts underwent lymphodepletion with cyclophosphamide (cy) 300 mg/m 2 (n=66) or cy 250 mg/m 2 plus fludarabine 25 mg/m 2 (n=8) prior to receiving LCAR-B38M at a median dose of 0.51 × 10 6 (range, 0.07-2.10 × 10 6 ) CAR-positive T cells/kg in a single (n=9) or 3 split (n=65) infusions. Results: Pts were enrolled from 30 Mar 2016 to 26 Nov 2017. As of 30 Nov 2022, median FU was 65.4 mo (range, 0.4-78.8). 74 pts had received LCAR-B38M (median age, 54.5 y; 60.8% male; median [range] 3 [1-9] prior lines of therapy [LOT]; 44.6% ISS stage I; 28.4% ISS stage III; 29.7% with extramedullary disease [EMD]; 35.7% cytogenetic high risk). No new CAR-T cell-related toxicities were reported in the analysis. ORR (87.8%), CR rate (73.0%), MRD-negative CR rate (67.6%), median DOR (23 mo), and media...