小细胞肺癌治疗新药Tarlatamab药理作用及临床评价

doi:10.19803/j.1672-8629.20240354

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (9): 1078-1080.
DOI: 10.19803/j.1672-8629.20240354

• 综述 • 上一篇

小细胞肺癌治疗新药Tarlatamab药理作用及临床评价

郑丽¹, 张凯华², 孙雪林^3,*

¹中国航天科工集团七三一医院药学部,北京 100074;
²中国航天科工集团七三一医院胸外科,北京 100074;
³北京医院药学部,北京 100730

收稿日期:2024-05-27 出版日期:2024-09-15 发布日期:2024-09-14
通讯作者: ^*孙雪林,女,博士,副主任药师,老年慢病管理与药物警戒。E-mail：sxl1220@163.com
作者简介:郑丽,女,博士,主管药师,循证医学与抗肿瘤药物管理。
基金资助:
中央高水平医院临床科研业务费资助（BJ-2023- 200）; 国家重点研发计划（2020YFC2009001）; 七三一医院院级科研基金（2022-QSYN-01）

Pharmacological effect and clinical evaluation of tarlatamab against small cell lung cancer

ZHENG Li¹, ZHANG Kaihua², SUN Xuelin^3,*

¹Department of Pharmacy, China Aerospace Science & Industry Corporation 731 Hospital, Beijing 100074, China;
²Department of Thoracic Surgery, China Aerospace Science & Industry Corporation 731 Hospital, Beijing 100074, China;
³Department.of Pharmacy, Beijing Hospital, Beijing 100730, China

Received:2024-05-27 Online:2024-09-15 Published:2024-09-14

摘要/Abstract

摘要： 小细胞肺癌是一种高度侵袭性神经内分泌癌,易转移且进展快,耐药率及复发率高。目前的治疗方案对患者的生存获益非常有限。2024年5月16号,美国食品药品监督管理局（FDA）批准tarlatamab上市,为既往接受过一线或二线治疗的小细胞肺癌患者提供了新的治疗方案。临床研究显示本品治疗效果佳且安全性高。本文对其药理作用、药代动力学特征、临床评价、安全性及用法用量进行简要概述。

关键词: 小细胞肺癌, tarlatamab, 临床评价, 安全性

Abstract: Small cell lung cancer (SCLC) is a highly invasive neuroendocrine carcinoma that is prone to metastasis and progression, with high rates of drug resistance and recurrence. The current treatment options have limited benefits for patient survival. On May 16, 2024, the FDA approved the marketing of tarlatamab, providing a new treatment plan for SCLC patients who have previously received first-line or second-line treatment. Clinical studies have shown that this drug is effctive and safe. This article reviews the pharmacological effects，clinical studies，safety，usage and dosage of tarlatamab.

Key words: small cell lung cancer, tarlatamab, clinical evaluation, safety

中图分类号:

R979.1

郑丽, 张凯华, 孙雪林. 小细胞肺癌治疗新药Tarlatamab药理作用及临床评价[J]. 中国药物警戒, 2024, 21(9): 1078-1080.

ZHENG Li, ZHANG Kaihua, SUN Xuelin. Pharmacological effect and clinical evaluation of tarlatamab against small cell lung cancer[J]. Chinese Journal of Pharmacovigilance, 2024, 21(9): 1078-1080.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/10.19803/j.1672-8629.20240354

https://zgywjj.magtechjournal.com/CN/Y2024/V21/I9/1078

参考文献

[1] CHEN G, LI Y, JIANG CH, et al.Analysis of one case of deep coma and severe drug-induced liver injury caused by sofantinib tablets and sustained-release hydroxycodone tablets[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2023, 20(11): 1296-1298, 1302.
[2] RUDIN CM, BRAMBILLA E, FAIVRE FC, et al.Small-cell lung cancer[J]. Nature Reviews Disease Primers, 2021, 7(1): 3.
[3] HORN L, MANSFIELD AS, SZCZESNA A, et al.First-line Atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer[J]. The New England Journal of Medicine, 2018, 379(23): 2220-2229.
[4] PAZ-ARES L, CHEN Y, REINMUTH N, et al.Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN[J]. ESMO Open, 2022, 7(2): 100408.
[5] DOMINE M, MORAN T, ISLA D, et al.SEOM clinical guidelines for the treatment of small-cell lung cancer (SCLC) (2019)[J]. Clinical & Translational Oncology, 2020, 22(2): 245-255.
[6] SALTOS A, ANTONIA S.Breaking the impasse: advances in treatment of small cell lung cancer[J]. Clinics in Chest Medicine, 2020, 41(2): 269-280.
[7] GANTI AKP, LOO BW, BASSETTI M, et al.Small cell lung cancer, version 2.2022, NCCN clinical practice guidelines in oncology[J]. Journal of the National Comprehensive Cancer Network, 2021, 19(12): 1441-1464.
[8] TENDLER S, RUDIN CM.Tarlatamab: new star on the horizon for small-cell lung cancer?[J] Journal of Clinical Oncology, 2023, 41(16): 2877-2880.
[9] SAUNDERS LR, BANKOVICH AJ, ANDERSON WC, et al. A DLL3-targeted antibody-drug conjugate eradicates high-grade pulmonary neuroendocrine tumor-initiating cells in vivo[J]. Science Translational Medicine, 2015, 7(302): 302ra136.
[10] SABARI JK, LOK BH, LAIRD JH, et al.Unravelling the biology of SCLC: implications for therapy[J]. Nature Reviews Clinical Oncology, 2017, 14(9): 549-561.
[11] FDA. Tarlatamab-dlle (Imdelltra)[EB/OL]. (2024-05-16)[2024-05-26]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf.
[12] AHN MJ, CHO BC, FELIP E, et al.Tarlatamab for patients with previously treated small-cell lung cancer[J]. The New England Journal of Medicine, 2023, 389(22): 2063-2075.
[13] CHUNG HC, PIHA-PAUL SA, LOPEZ-MARTIN J, et al.Pembrolizumab after two or more lines of previous therapy in patients with recurrent or metastatic SCLC: results from the KEYNOTE-028 and KEYNOTE-158 studies[J]. Journal of Thoracic Oncology, 2020, 15(4): 618-627.
[14] READY N, FARAGO AF, DE BF, et al.Third-line nivolumab monotherapy in recurrent SCLC: checkmate 032[J]. Journal of Thoracic Oncology, 2019, 14(2): 237-244.
[15] PAZ-ARES L, CHAMPIAT S, LAI WV, et al.Tarlatamab, a first-in-class DLL3-targeted bispecific T-cell engager, in recurrent small-cell lung cancer: an open-label, phase I study[J]. Journal of Clinical Oncology, 2023, 41(16): 2893-2903.
[16] PAZ-ARES L, DVORKIN M, CHEN Y, et al.Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial[J]. Lancet, 2019, 394(10212): 1929-1939.
[17] TRIGO J, SUBBIAH V, BESSE B, et al.Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial[J]. The Lancet Oncology, 2020, 21(5): 645-654.
[18] VON PAWEL J, JOTTE R, SPIGEL DR, et al.Randomized phase Ⅲ trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer[J]. Journal of Clinical Oncology, 2014, 32(35): 4012-4019.

小细胞肺癌治疗新药Tarlatamab药理作用及临床评价

Pharmacological effect and clinical evaluation of tarlatamab against small cell lung cancer

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

[1]	刘婷, 曹忠强, 何文佳, 袁秀丽, 陈泽彬, 李学娟. 培门冬酶注射液致急性重症胰腺炎1例分析[J]. 中国药物警戒, 2024, 21(9): 1075-1077.
[2]	王岩, 滕晶晶, 杨同金, 夏新, 喻丹丹, 占海兵, 杨文明. 智脑胶囊长期毒性研究[J]. 中国药物警戒, 2024, 21(8): 878-883.
[3]	孙一鑫, 聂晓璐, 王晓玲, 郭鹏. 国内外基于真实世界数据的药品上市后安全性主动监测系统对比分析[J]. 中国药物警戒, 2024, 21(8): 892-899.
[4]	刘倩, 李博, 疏欣扬. 蓝芩口服液联合抗菌药物治疗急性扁桃体炎有效性与安全性的系统评价与Meta分析[J]. 中国药物警戒, 2024, 21(8): 916-920.
[5]	刘连奇, 肖典, 钟武, 周辛波, 李松. 抗体偶联药物的相关毒性和研究对策[J]. 中国药物警戒, 2024, 21(7): 721-729.
[6]	姜海伦, 周辛波, 肖典, 钟武, 李松. 蛋白水解靶向嵌合体类药物及其潜在风险分析[J]. 中国药物警戒, 2024, 21(7): 730-734.
[7]	胡笑文, 张才煜, 王峰峰, 濮恒婷, 刘阳, 陈华. 基于规定日服用剂量改进药物肝毒性预测方法的研究[J]. 中国药物警戒, 2024, 21(7): 776-780.
[8]	程毅菁, 李涛, 刘军廷, 黄贵民, 钟旭丽, 林爱华, 潘守东, 李龙, 白东升, 占小俊, 刘振江, 任韡, 聂晓璐, 邰隽. 基于真实世界数据的注射用尖吻蝮蛇血凝酶儿童用药安全性评价[J]. 中国药物警戒, 2024, 21(7): 787-790.
[9]	苏海, 昝孟晴, 牛剑钊, 马铃云, 刘倩. 高效液相色谱法测定乙醇对格列吡嗪控释片体外释放行为的影响[J]. 中国药物警戒, 2024, 21(6): 638-643.
[10]	潘知玉, 朱健, 于亚南, 刘骏, 姜燕华, 钱真真, 吴广, 王忠, 武红莉, 荆志伟. 3010例芪蛭通络胶囊的真实世界安全性研究[J]. 中国药物警戒, 2024, 21(6): 660-665.
[11]	邵波, 徐丽丽, 朱兰, 刘硕, 万浩, 黄光瑞. 湿毒清制剂肝损伤风险分析及思考[J]. 中国药物警戒, 2024, 21(6): 666-670.
[12]	孙雪林, 杜娇, 谭琴, 胡欣, 张亚同, 郑丽. 阿美替尼上市后不良反应分析[J]. 中国药物警戒, 2024, 21(6): 683-686.
[13]	于静, 帕拉提·热合曼, 赵婷, 冯继荣, 孙岩, 何磊. 拉考沙胺治疗4岁以下癫痫患儿疗效、安全性与血药浓度的相关性研究[J]. 中国药物警戒, 2024, 21(5): 559-562.
[14]	刘翠丽, 吴晨, 王涛. 吡拉西坦制剂安全性风险分析及思考[J]. 中国药物警戒, 2024, 21(5): 563-566.
[15]	杨波, 王梦娇, 胡丽丽, 王来成, 李倩, 孔飞飞, 吕冬梅, 沈佳妮. 385例PD-1抗肿瘤治疗的安全性研究及风险因素分析[J]. 中国药物警戒, 2024, 21(4): 447-450.