What question did this study set out to answer?

To evaluate the effectiveness and safety of oncolytic virus therapy in advanced malignancies through a review of clinical trials.

February 2, 2026

Efficacy and Safety of Oncolytic Viruses Immunotherapy in Advanced Malignancies

Key Points

To evaluate the effectiveness and safety of oncolytic virus therapy in advanced malignancies through a review of clinical trials.
Reviewed 188 clinical trials involving 5410 patients
Summarized immune responses, clinical responses, and treatment-related adverse events
Analyzed various administration routes and treatment types
Identified melanoma as the most common targeted tumor type
Reported objective response rate of 24.6% and disease control rate of 59.1% among 3536 patients
Found that intratumoral administration had higher response rates compared to intravenous
Noted manageable safety profile with most adverse events classified as Grades 1-2

Abstract

ABSTRACT Aim To provide insight into the efficacy and safety of oncolytic viruses (OVs) in advanced malignancies. Methods We reviewed 188 clinical trials, including 5410 patients. This review mainly summarized the clinical landscape of OVs, including the immune response, clinical response, and treatment‐related adverse events (TRAEs). Results We found that the most common tumor type targeted was melanoma (1586/541029.3%) and most patients were treated with OVs monotherapy (2893/541053.5%) via intratumoral (2917/541054.4%) or intravenous (1686/541061.2) delivery. Sixty‐eight (68/18836.2%) and 74 (74/18836.4%) studies evaluated the tumor microenvironment and systemic immune response, respectively. Importantly, an increase in tumor‐specific cytotoxic T lymphocytes was reported in 15 (8.0%) trials. There were 103 (54.8%) and 13 (6.9) studies reporting humoral and cellular virus‐specific immune responses, respectively. 129 (129/18868.6%) studies evaluated clinical efficacy in 3536 patients, with objective response and disease control of 870 (24.6%) and 2615 (59.1%), respectively. Subgroup analysis revealed an objective response in 522 (34.5%) and disease control in 953 (62.9%) of the 1514 patients in the herpes simplex virus (HSV) subgroup. The percentages of patients with objective response and disease control for different administration routes, including intratumoral (29.3%; 63.1%) and intravenous (18.1%; 52.8%) injections, and for different treatments including combination (31.8%; 65.1%) and monotherapy (17.3%; 55.1%), were summarized. Immunotherapy may be a promising combination therapy, with objective response and disease control occurring in high proportions of patients (35.9%; 59.9%). Moreover, OVs demonstrated a manageable safety profile, with most TRAEs being Grades 1–2. Conclusions This study provides a general overview of the status of OVs clinical trials, but further research is needed to determine the optimal treatment regimen and combination strategy.

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