Li Ke, Zhao Yalong, Hu Xiaocong, Jiao Jiao, Wang Wei, Yao Hongtao
Department of Medical Affairs, Guangdong Techpool Bio-pharma Co., Ltd. China.
Am J Transl Res. 2022 Jun 15;14(6):4192-4206. eCollection 2022.
Oncolytic viruses (OVs) are natural or recombinant viruses that selectively infect and kill cancer cells without harming normal cells. This review aimed to explore some ongoing and completed clinical studies on OVs, in China and worldwide, to depict a comprehensive landscape of OV clinical trials, and summarize the existing evidence on safety and effectiveness of oncolytic therapy against tumors.
Used the Center for Drug Evaluation of China National Medical Products Administration (NMPA), Chinese Clinical Trial Registry (ChiCTR), International Clinical Trials Registry Platform, ClinicalTrials.gov website, China National Knowledge Infrastructure (CNKI), and PubMed.
As of October 1, 2021, 408 clinical trials on 31 OV products have been conducted, with oncolytic DNA viruses being the most investigated ones; phase I and phase II clinical studies accounted for approximately 80% of all studies. Published clinical studies have shown that OVs, such as H101, T-VEC, G47Δ, OH2, T3011, and Pelareorep, have significant anti-tumor effects on various tumors, with only mild adverse events. When OVs are used together with antiviral drugs in the clinic, drug interactions should be considered based on the sensitivity of OVs to antiviral drugs.
OVs exhibit accurate oncolysis and favorable safety, and have positive effects on a variety of tumor treatments. It is worth noting that most of the OVs under development are still in their early stages, which is both a challenge and a promising prospect.
溶瘤病毒(OVs)是天然或重组病毒,可选择性感染并杀死癌细胞而不损害正常细胞。本综述旨在探讨中国和全球范围内一些正在进行和已完成的关于溶瘤病毒的临床研究,以描绘溶瘤病毒临床试验的全面概况,并总结溶瘤治疗针对肿瘤的安全性和有效性的现有证据。
使用中国国家药品监督管理局药品审评中心(NMPA)、中国临床试验注册中心(ChiCTR)、国际临床试验注册平台、ClinicalTrials.gov网站、中国知网(CNKI)和PubMed。
截至2021年10月1日,已对31种溶瘤病毒产品进行了408项临床试验,其中溶瘤DNA病毒是研究最多的;I期和II期临床研究约占所有研究的80%。已发表的临床研究表明,H101、T-VEC、G47Δ、OH2、T3011和Pelareorep等溶瘤病毒对各种肿瘤具有显著的抗肿瘤作用,且不良事件较轻。在临床中溶瘤病毒与抗病毒药物联合使用时,应根据溶瘤病毒对抗病毒药物的敏感性考虑药物相互作用。
溶瘤病毒表现出精确的溶瘤作用和良好的安全性,对多种肿瘤治疗有积极作用。值得注意的是,大多数正在研发的溶瘤病毒仍处于早期阶段,这既是挑战也是充满希望的前景。