彭博利珠单抗在中国微卫星不稳定性高/错配修复缺陷肿瘤患者中的应用KEYNOTE-158。

IF 2.7 4区医学 Q3 IMMUNOLOGY

Immunotherapy Pub Date : 2024-03-20 DOI:10.2217/imt-2023-0294

Jianming Xu, Yimin Mao, Nong Xu, Yuxian Bai, Dong Wang, Xiaojun Chen, Xianli Yin, Yanhong Deng, Jianwei Yang, Jieqing Zhang, Jie Tang, Yi Huang, Jiayi Li, Suxia Luo, Hong Zheng, Weidong Zhao, Miaomiao Xu, Nan Li, Yixiang Mao, Alexander Gozman, Xiaohua Wu

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引用次数: 0

摘要

目的：评估Pembrolizumab对KEYNOTE-158（队列L）中微卫星不稳定性高（MSI-H）/错配修复缺陷（dMMR）肿瘤华裔患者的治疗效果。研究方法MSI-H/dMMR晚期肿瘤患者接受pembrolizumab 200 mg静脉注射，Q3W。主要终点为总反应率（ORR）。次要终点为应答持续时间（DOR）、无进展生存期（PFS）和总生存期（OS）。结果：24 名患者入选（20 名可进行疗效评估）。中位随访时间为 12.4 个月，ORR 为 70%。DOR、PFS和OS均未达标。共有 19 例（79%）患者发生了治疗相关不良事件（AE；4 例[17%]≥3 级），8 例（33%）发生了免疫介导的不良事件（4 例[17%]≥3 级）。结论Pembrolizumab提供了有意义和持久的应答，且安全性可控。这些结果与全球试验报告的结果一致。

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Pembrolizumab in patients from China with microsatellite instability-high/mismatch repair deficient tumors: KEYNOTE-158.

Aim: To evaluate pembrolizumab in patients of Chinese descent with microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) tumors enrolled in KEYNOTE-158 (Cohort L). Methods: Patients with MSI-H/dMMR advanced tumors received pembrolizumab 200 mg IV Q3W. Primary end point was overall response rate (ORR). Secondary end points were duration of response (DOR), progression-free survival (PFS) and overall survival (OS). Results: 24 patients were enrolled (20 were evaluable for efficacy). With median follow-up of 12.4 months, the ORR was 70%. DOR, PFS and OS were all not reached. A total of 19 (79%) patients had a treatment-related adverse event (AE; grade ≥3 in 4 [17%]), and 8 (33%) had an immune-mediated AE (grade ≥3 in (4 [17%]). Conclusion: Pembrolizumab provided meaningful and durable responses with manageable safety. These results are consistent with those reported for the global trial.

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来源期刊

Immunotherapy 医学-免疫学

CiteScore

5.00

自引率

3.60%

发文量

113

审稿时长

6-12 weeks

期刊介绍： Many aspects of the immune system and mechanisms of immunomodulatory therapies remain to be elucidated in order to exploit fully the emerging opportunities. Those involved in the research and clinical applications of immunotherapy are challenged by the huge and intricate volumes of knowledge arising from this fast-evolving field. The journal Immunotherapy offers the scientific community an interdisciplinary forum, providing them with information on the most recent advances of various aspects of immunotherapies, in a concise format to aid navigation of this complex field. Immunotherapy delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for this vitally important area of research. Unsolicited article proposals are welcomed and authors are required to comply fully with the journal''s Disclosure & Conflict of Interest Policy as well as major publishing guidelines, including ICMJE and GPP3.