Tarlatamab（tarlatamab-dlle：IMDELLTRA™）是安进（Amgen）开发的一种首创、半衰期延长的双特异性 δ 样配体 3 (DLL3) 导向的 CD3 T 细胞接合剂，用于治疗小细胞肺癌（ SCLC）和神经内分泌前列腺癌。 Tarlatamab 与肿瘤细胞表面的 DLL3 和细胞毒性 T 淋巴细胞 (CTL) 表面的 CD3 结合，导致 T 细胞激活、炎症细胞因子的释放以及 CTL 介导的表达 DLL3 的肿瘤细胞的细胞死亡。 2024 年 5 月，tarlatamab 在美国首次获得批准，用于治疗在铂类化疗期间或之后疾病进展的成人广泛期 SCLC (ES-SCLC)。根据关键 2 期 DeLLphi-301 研究中的总体缓解率和缓解持续时间，Tarlatamab 获得了针对该适应症的加速批准，并且继续批准可能取决于验证性试验中临床益处的证明。 Tarlatamab 正在巴西、加拿大、以色列和英国接受监管审查，多个国家正在进行临床研究。本文总结了 tarlatamab 开发过程中的里程碑，这些里程碑导致首次批准用于治疗铂类化疗期间或之后疾病进展的 ES-SCLC。© 2024。作者获得 Springer Nature Switzerland AG 的独家许可。

Tarlatamab (tarlatamab-dlle: IMDELLTRA™) is a first-in-class, half-life extended bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager being developed by Amgen for the treatment of small cell lung cancer (SCLC) and neuroendocrine prostate cancer. Tarlatamab binds to DLL3 on the surface of tumour cells and CD3 on the surface of cytotoxic T lymphocytes (CTLs), resulting in T-cell activation, release of inflammatory cytokines and CTL-mediated cell death of DLL3-expressing tumour cells. In May 2024, tarlatamab received its first approval in the USA for the treatment of adults with extensive stage SCLC (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab received accelerated approval for this indication based on overall response rate and duration of response in the pivotal phase 2 DeLLphi-301 study, and continued approval may be contingent on the demonstration of clinical benefit in a confirmatory trial(s). Tarlatamab is under regulatory review in Brazil, Canada, Israel and the UK, and clinical studies are underway in multiple countries. This article summarizes the milestones in the development of tarlatamab leading to this first approval for ES-SCLC with disease progression on or after platinum-based chemotherapy.© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.