Efficacy and tolerability of talimogene laherparepvec in treatment of solid tumors: A systematic review.

e14554 Background: Talimogene laherparepvec (T-VEC) is an oncolytic virus engineered to selectively replicate within tumor cells, leading to cell lysis and enhanced systemic antitumor immunity through expression of granulocyte-macrophage colony-stimulating factor (GM-CSF). Since its FDA approval in 2015 for the treatment of unresectable melanoma, T-VEC has generated interest for its potential application in other malignancies. However, a comprehensive synthesis of response rates, survival outcomes, and adverse events associated with T-VEC across non-melanoma solid tumors is lacking. This systematic review aims to synthesize available evidence on the efficacy and safety of T-VEC across a range of solid tumors to better define its clinical utility beyond melanoma. Methods: A systematic literature search of PubMed, Embase, and Scopus was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Peer-reviewed clinical studies reporting outcomes of T-VEC therapy in non-melanoma solid tumors were included. Extracted variables included patient age, cancer type, T-VEC dosage, treatment duration, survival outcomes, treatment response, and adverse events. Median overall survival (OS), complete response rates, and grade ≥ 3 adverse events were compared across studies. Results: Of 1,664 identified records, 10 clinical studies met inclusion criteria, encompassing outcomes across 11 cancer types. These included breast cancer (n = 5), sarcomas (n = 3), basal cell carcinoma (n = 1), pancreatic cancer (n = 1), and colorectal cancer (n = 1). Clinical outcomes varied by tumor type. Partial response or stable disease was achieved in 76% of sarcoma patients, while complete responses were observed in 33% of patients with breast cancer and basal cell carcinoma. No cases of progressive disease were reported among basal cell carcinoma patients. Median OS ranged from 3.8 to 30 months, with the shortest survival observed in colorectal cancer and the longest in a breast cancer cohort. The most frequently reported grade ≥ 3 adverse events were hematologic, cardiovascular, and constitutional or administration site–related. Conclusions: T-VEC demonstrated promising efficacy and an acceptable safety profile in basal cell carcinoma and sarcomas, with more heterogeneous responses observed in breast cancer. Further studies are warranted to better characterize the clinical outcomes of T-VEC in non-melanoma solid tumors, particularly in combination with other immunotherapeutic agents.