塔拉塔马布用于以前接受过治疗的小细胞肺癌患者
Myung-Ju Ahn1, Byoung Chul Cho1, Enriqueta Felip1
1From Samsung Medical Center, Sungkyunkwan University School of Medicine (M.-J.A.), and Yonsei Cancer Center, Yonsei University College of Medicine (B.C.C.), Seoul, and Seoul National University Bundang Hospital, Seongnam (J.-S.L.) - all in South Korea; Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (E.F.) and Hospital de la Santa Creu i Sant Pau (M. Majem), Barcelona, Hospital Universitari i Politecnic La Fe, Valencia (O.J.-V.), and Hospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Unit, Complutense University and Ciberonc, Madrid (L.P.-A.) - all in Spain; the Department of Medical Oncology, Saint Loukas Hospital, Thessaloniki, Greece (I.K.); the Department of Respiratory Medicine, Okayama University Hospital, Okayama (K.O.), the Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa (H.I.), and Wakayama Medical University Hospital, Wakayama (H.A.) - all in Japan; Klinische Abteilung für Pneumologie, Universitätsklinikum Krems, Krems, Austria (S. Handzhiev); the Department of Oncology and Radiotherapy and Early Phase Clinical Trials Center, Medical University of Gdansk, Gdansk, Poland (R.D.); the Department of Internal Medicine, Center for Integrated Oncology, University Hospital Cologne, Cologne (J.W.), Lungen Clinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf (M.R.), and the Translational Oncology-Early Clinical Trial Unit, Comprehensive Cancer Center Mainfranken and Bavarian Cancer Research Center, Universitätsklinikum Würzburg, Würzburg (H.-D.H.) - all in Germany; Christie NHS Foundation Trust and University of Manchester, Manchester, United Kingdom (F.B.); West Virginia University Health Sciences Center, Morgantown (J.B.A.); the Department of Pulmonary Medicine, Erasmus MC Cancer Institute, Rotterdam, the Netherlands (A.-M.C.D.); Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.); the Division of Hematology-Oncology, Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh (T.K.O.), and Fox Chase Cancer Center, Philadelphia (H.B.) - both in Pennsylvania; Winship Cancer Institute of Emory University, Atlanta (S.S.R.); Sarah Cannon Research Institute at Tennessee Oncology, Nashville (M.L.J.); and Amgen, Thousand Oaks, CA (S. Huang, S.M., M. Minocha, T.J., P.M., E.S.A.).
塔拉塔马布在以前接受过小细胞肺癌治疗的患者中表现出显著的抗瘤活性和持久的反应. 10毫克的剂量显示出有希望的生存结果与可管理的安全性,包括细胞因子释放综合征.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 塔拉塔马布是一种双特异性T细胞激活剂,向DLL3和CD3.
- 以前的第一阶段试验表明,在小细胞肺癌 (SCLC) 中具有有前途的抗瘤活性.
研究的目的:
- 为了评估tarlatamab在先前治疗的SCLC患者中的抗瘤活性和安全性.
- 评估了两种不同的tarlatamab剂量的客观反应率和生存结果.
主要方法:
- 第2期,开放性试验,涉及220名先前接受过治疗的SCLC患者.
- 塔拉塔马布每两周内静脉注射10毫克或100毫克.
- 主要终点:每个RECIST的客观响应率 (ORR) v1.1.1.
主要成果:
- 10毫克剂量的ORR为40%,100毫克剂量的ORR为32%.
- 无进展生存时间的中位数为4.9个月 (10毫克) 和3.9个月 (100毫克).
- 常见的不良事件包括细胞因子释放综合征 (CRS),食欲下降和焦灼症;3级CRS不常见.
结论:
- 塔拉塔马布,特别是10毫克的剂量,在先前治疗的SCLC中表现出抗瘤活性和持久的反应.
- 观察到有希望的生存结果,但没有发现新的安全信号.
- 塔拉他马布代表了晚期SCLC的潜在新治疗选择.
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