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idecabtagene vicleucel (ide-cel, bb2121) 在复发/难治性多发性骨髓瘤日本患者中的 II 期结果

英文原题:Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma.

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Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma.

PubMed 2023/01/24(内容时间) Int J Hematol Q3 · IF 1.9(JCR 2025)

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研究概要

ide-cel 在日本 RRMM 患者中产生了深度、持久的缓解,安全性特征可控且可预测。

中文摘要

在II期KarMMa试验中,复发/难治性多发性骨髓瘤(RRMM)患者接受靶向B细胞成熟抗原的嵌合抗原受体(CAR)T细胞疗法idecabtagene vicleucel(ide-cel)后,获得深度且持久的缓解。本文报告KarMMa日本患者队列的亚组分析。

成人RRMM患者既往接受过3种治疗方案,包括蛋白酶体抑制剂、免疫调节剂和抗CD38抗体,且疾病对最近一次治疗难治;患者接受目标剂量为4.5×10⁸ CAR阳性T细胞的ide-cel治疗。

9名患者接受ide-cel治疗。中位随访12.9个月时,总缓解率为89%。最佳总体疗效为:5名患者(56%)达到严格完全缓解,3名(33%)达到非常好的部分缓解,1名病情稳定。中位缓解持续时间尚未达到。所有患者均发生2级细胞因子释放综合征,1名患者发生2级神经毒性,但均已缓解。2名患者死亡,死因分别为浆细胞骨髓瘤和总体健康状况恶化。

ide-cel在日本RRMM患者中带来深度、持久的缓解,安全性可耐受且符合预期。这些结果与KarMMa试验中的非日本人群相似。

展开英文摘要原文

In the phase 2 KarMMa trial, patients with relapsed/refractory multiple myeloma (RRMM) achieved deep and durable responses with idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T cell therapy. Here we report a sub-analysis of the Japanese cohort of KarMMa.

Adult patients with RRMM who had received 3 prior treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and had disease refractory to last treatment received ide-cel at a target dose of 450 10 6 CAR positive T cells.

Nine patients were treated with ide-cel. The overall response rate was 89% (median follow-up, 12.9 months). The best overall response was stringent complete response in 5 patients (56%), very good partial response in 3 (33%), and stable disease in 1. Median duration of response was not reached. All patients experienced grade 2 cytokine release syndrome and one patient experienced grade 2 neurotoxicity, but all resolved. Two patients died, one each from plasma cell myeloma and general health deterioration.

Ide-cel yielded deep, durable responses with a tolerable and predictable safety profile in Japanese patients with RRMM. These results are similar to those of the non-Japanese population in KarMMa.

论文信息

作者
Minakata D、Ishida T、Ando K、Suzuki R、Tanaka J、Hagiwara S、Ananthakrishnan R、Kuwayama S
单位
Division of Hematology, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan. daisuke_minakata_kappa@yahoo.co.jp.Japan
文献类型
II 期临床试验
期刊
International journal of hematology2023 May
原文标识
PubMed 36690910 · DOI 10.1007/s12185-023-03538-6