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Introduction: Talimogene laherparepvec (T-VEC; IMLYGIC, Amgen Inc.) is an oncolytic immunotherapy approved in Europe for the treatment of unresectable metastatic melanoma (stage IIIB-IVM1a). This study characterised real-world use of T-VEC in four European countries.
Methods: Data on demographics, treatment pattern, safety, and clinical effectiveness were examined in a retrospective chart review of patients with stage IIIB-IVM1a unresectable melanoma treated with T-VEC in surgical (the Netherlands) and medical (Austria, Germany, UK) oncology settings.
Results: Overall, 66 patients were included (the Netherlands: n = 31; Austria, Germany, UK: n = 35). The median age was 69 years and 59.1% were female. At the time of T-VEC initiation, 47 patients (71.2%) had stage IIIB/C disease; of these, 30 were from the Netherlands. Although 72.7% patients overall received T-VEC as first-line therapy, this was higher in the Netherlands than the other countries (93.5% vs 54.3%). Of the 47 patients who discontinued T-VEC, 26 (55.3%) had no remaining injectable lesions (potentially indicating complete response); 20/26 of these patients were from the Netherlands. One patient discontinued T-VEC due to toxicity.
Conclusion: This study is the first comprehensive multinational evaluation of the use of T-VEC to treat unresectable stage IIIB/C-IVM1a melanoma in real-world clinical practice in Europe. The differences between European countries were apparent, with physicians in the Netherlands using T-VEC in patients with earlier advanced disease stage and in the first-line setting compared with other countries.
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http://dx.doi.org/10.1007/s12325-020-01590-w | DOI Listing |
Ann Surg
September 2025
Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Objective: We hypothesized that anatomic location of metastatic melanoma is associated with the degree of therapeutic response to TVEC.
Summary: TVEC is the first FDA-approved injectable oncolytic virus to treat unresectable stage IIIB-IV metastatic melanoma patients. Previously published real-world outcomes demonstrated a 39% complete response (CR) rate to TVEC.
J Oncol Pharm Pract
September 2025
Department of Research & Development, Squad Medicine and Research (SMR), Amadalavalasa, Andhra Pradesh, India.
Cancer vaccines represent a transformative shift in oncology, aiming to prevent malignancies or treat established cancers by training the immune system to recognize tumor-specific or tumor-associated antigens. This review explores the diverse platforms and mechanisms supporting cancer vaccines, ranging from prophylactic vaccines such as HPV and hepatitis B vaccines that have significantly reduced virus-related cancers to therapeutic vaccines like Sipuleucel-T and T-VEC that extend survival in prostate cancer and melanoma. Vaccine types are classified, and delivery platforms including mRNA, peptide, dendritic cell and viral vector-based approaches are examined alongside pivotal clinical trial outcomes.
View Article and Find Full Text PDFJ Clin Pharmacol
September 2025
Clinical Pharmacology, Modeling and Simulation, Amgen Inc., South San Francisco, CA, USA.
Oncolytic viruses are an emerging class of immunotherapies for cancer treatment. Talimogene laherparepvec (T-VEC) is a first-in-class oncolytic virus approved globally for advanced melanoma. Herein, we describe the quantitative clinical pharmacology aspects of T-VEC that supported the development of this unique therapy.
View Article and Find Full Text PDFVaccines (Basel)
August 2025
State Key Laboratory of Drug Regulatory Sciences, National Institutes for Food and Drug Control, Beijing 102629, China.
Oncolytic virus (OV) immunotherapy, particularly with oncolytic herpes simplex virus (oHSV), has become a promising new strategy in cancer treatment. This field has achieved significant clinical milestones, highlighted by the FDA approval of Talimogene laherparepvec (T-VEC) for melanoma in 2015 and the approval of Teserpaturev/G47Δ for malignant glioma in Japan in 2021. This review synthesizes the key preclinical and clinical advancements in oHSV therapy over the last decade, critically analyzing the core challenges in target selection, genetic modification, administration routes, and targeted delivery.
View Article and Find Full Text PDFFront Microbiol
August 2025
Department of Radiation Oncology, All India Institute of Medical Sciences, Jodhpur, India.
Background: Head and neck squamous cell carcinoma remains a significant global health burden, particularly in low-resource regions like India. Conventional treatments often fall short in achieving durable responses, prompting the need for novel therapies.
Objective: This review outlines the clinical progress, mechanism of action, and emerging therapeutic potential of oncolytic viruses (OVs) in the management of HNSCC, with an emphasis on ongoing trials, approved agents, and future directions.