Shirley Matt
Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
Drugs. 2024 Dec;84(12):1659-1663. doi: 10.1007/s40265-024-02119-z. Epub 2024 Nov 19.
Enlonstobart (Enshuxing), a recombinant, fully humanised immunoglobulin G4 monoclonal antibody targeted against programmed cell death protein 1 (PD-1), is being developed by the CSPC Pharmaceutical Group for the treatment of advanced cervical cancer and other solid tumours. Enlonstobart received its first approval (a conditional marketing authorisation) in June 2024, in China, for use in patients with recurrent or metastatic programmed cell death ligand 1 (PD-L1)-positive cervical cancer who have failed previous platinum-containing chemotherapy. Phase III clinical evaluation of enlonstobart for use as first-line treatment (in combination with chemotherapy ± bevacizumab) in patients with recurrent or metastatic PD-L1-positive cervical cancer is also underway in China. Additionally, phase II clinical development of enlonstobart (as a part of combination therapy) for use against a range of other solid tumour types is continuing. This article summarises the milestones in the development of enlonstobart leading to this first approval for recurrent or metastatic cervical cancer.
恩沃利单抗（恩适得）是一种重组的、完全人源化的免疫球蛋白G4单克隆抗体，靶向程序性细胞死亡蛋白1（PD-1），由中国生物制药集团开发，用于治疗晚期宫颈癌和其他实体瘤。恩沃利单抗于2024年6月在中国获得首个批准（有条件上市许可），用于既往含铂化疗失败的复发或转移性程序性细胞死亡配体1（PD-L1）阳性宫颈癌患者。恩沃利单抗作为复发或转移性PD-L1阳性宫颈癌患者一线治疗（联合化疗±贝伐珠单抗）的III期临床评估也在中国进行。此外，恩沃利单抗针对一系列其他实体瘤类型（作为联合治疗的一部分）的II期临床开发也在继续。本文总结了恩沃利单抗在复发性或转移性宫颈癌首次获批之前的研发历程中的关键节点。
