2298. Infections in Patients Receiving TVEC Therapy

Abstract

BackgroundOncolytic viral immunotherapy is an emerging cancer treatment, but the infectious complications are not well described outside of clinical trials. Genetically engineered replication competent herpes simplex virus (HSV-1), commercially known as IMLGYIC® (AmGen) or talimogene laherparepvec (TVEC) was the first FDA approved agent in this class and is used for the local intralesional treatment (of unresectable melanoma. TVEC is derived from a wild-type(WT) strain of HSV-1 (JS—1), which is modified to attenuate off-target effects and promote selective proliferation within cancer cells. Despite these changes local and systemic infection with HSV have been reported from trials and is the subject of an FDA mandated post-marketing review. Here we review the infectious complications of the first cohort of patients treated at our institution post-FDA approval.MethodsDemographic and clinical information for 52 adult patients treated for unresectable melanoma with TVEC following FDA approval in 2015 was extracted from the EMR for the period October 1, 2015–June 30, 2018. EMR and microbiologic data were reviewed for evidence of local site reaction and disseminated infection.ResultsNo cases of disseminated HSV infection were identified during the study period. Of cutaneous reactions, none were documented as greater than severity grade 2, based on standard adverse event reporting criteria. 3 (50%) grade 1–2 cutaneous reactions were deemed probable or definitely related to TVEC and described as pruritis or rash. 12 (23%) patients had any microbiologically confirmed infection identified following TVEC therapy; 6 were bacterial (3 UTI, 1BSI, 2 wound). 8 episodes of viral infections occurred (5 respiratory and 3 GI). A single patient was noted to have localized HSV dermal lesions more than one year after the final TVEC.ConclusionNo local or disseminated HSV infections were encountered in the study cohort. Bacterial skin and soft-tissue infection were uncommon. Most other infections were unrelated to TVEC therapy. Real-world review of the use of an HSV-derived oncolytic viral vector therapy mimics reported infectious complications from clinical trials.Disclosures All authors: No reported disclosures.