转化疗法中的一个新兴类别是溶瘤病毒（OVs）。它们的优势在于能够选择性地在肿瘤细胞内进行复制，传递多种真核生物转基因载荷，引起免疫原性细胞死亡并提高抗肿瘤免疫力，并且和其它癌症治疗方法的安全性方面大部分不重叠。目前，在全球范围内，已经批准了四种溶瘤病毒和一种非溶瘤病毒用于癌症治疗，其中talimogene laherparepvec（T-VEC）是唯一得到广泛批准的治疗方法。T-VEC主要用于治疗首次手术后复发黑色素瘤患者，并于2015年首次获得批准。随着越来越多患者接受T-VEC治疗的临床经验数据的积累，以及其他溶瘤病毒在多种癌症中的临床试验数据的出现，我们需要更好地了解OVs的潜在生物学和药理学机制，以充分发挥这些药物在癌症患者中的治疗作用。在本综述中，我们总结了现有数据，并提供了在临床实践中如何优化OVs使用的指导，重点关注T-VEC的临床经验。我们评述了当前处于临床开发中的一些新型OVs的数据，这些OVs作为单一治疗方式或作为联合治疗方案的一部分。我们还讨论了迄今为止限制OVs发展的一些临床前、临床和监管难题。 © 2023. Springer Nature Limited.

Oncolytic viruses (OVs) are an emerging class of cancer therapeutics that offer the benefits of selective replication in tumour cells, delivery of multiple eukaryotic transgene payloads, induction of immunogenic cell death and promotion of antitumour immunity, and a tolerable safety profile that largely does not overlap with that of other cancer therapeutics. To date, four OVs and one non-oncolytic virus have been approved for the treatment of cancer globally although talimogene laherparepvec (T-VEC) remains the only widely approved therapy. T-VEC is indicated for the treatment of patients with recurrent melanoma after initial surgery and was initially approved in 2015. An expanding body of data on the clinical experience of patients receiving T-VEC is now becoming available as are data from clinical trials of various other OVs in a range of other cancers. Despite increasing research interest, a better understanding of the underlying biology and pharmacology of OVs is needed to enable the full therapeutic potential of these agents in patients with cancer. In this Review, we summarize the available data and provide guidance on optimizing the use of OVs in clinical practice, with a focus on the clinical experience with T-VEC. We describe data on selected novel OVs that are currently in clinical development, either as monotherapies or as part of combination regimens. We also discuss some of the preclinical, clinical and regulatory hurdles that have thus far limited the development of OVs.© 2023. Springer Nature Limited.