Safety of talimogene laherparepvec: a real-world retrospective pharmacovigilance study based on FDA Adverse Event Reporting System (FAERS).

Abstract

Background: Oncolytic virus therapy is a rapidly evolving emerging approach for the medical management of cancer. Talimogene laherparepvec (T-VEC) is the first and only Food and Drug Administration (FDA)-approved oncolytic virus therapy. Considering that exactly how T-VEC works is not known, there is a strong need for a comprehensive pharmacovigilance study to identify safety signals of potential risks with T-VEC.

Objective: The objective of this study was to assess the risk of adverse events (AEs) related to T-VEC.

Methods: We implemented a pharmacovigilance study utilizing individual case safety reports (ICSRs) reported to the FDA Adverse Event Reporting System (FAERS) database dated from 2004 quarter 1 to 2023 quarter 3. In this study, we used two algorithms, reporting odds ratio (ROR) and information component (IC), to assess the risk of AEs related to T-VEC.

Results: A total of 1138 ICSRs of patients who received the T-VEC and reported to the FDA dated from 2004 quarter 1 to 2023 quarter 3 were available. A total of seven system organ classes (SOCs) demonstrated statistically significant signals, i.e. General disorders and administration site conditions, Injury, poisoning and procedural complication, Infections and infestations, Neoplasms benign, malignant and unspecified, Skin and subcutaneous tissue disorders, Hepatobiliary disorders, and Endocrine disorders. From the preferred term level perspective, the most reported AEs in T-VEC-treated patients were pyrexia, illness, influenza, influenza-like illness, and chills. Unexpected significant AEs were detected, such as sepsis, encephalitis, syncope, and lymphadenopathy.

Conclusions: Most AEs in T-VEC-treated patients have been previously mentioned in the prescriptive information or documented in other clinical trials. But safety signals were also be detected in 4 unexpected AEs (sepsis, encephalitis, syncope, and lymphadenopathy). Further clinical trials need to be undertaken to facilitate a more comprehensive comprehension of the safety profile of T-VEC.