#Rea study center trial#

The median time to response was 124 days (range: 44–397) ( figure 3). The aim of this study was to assess the outcome of melanoma patients treated with T-VEC in a real-life clinical setting. 11 14 15 Exactly this subgroup of patients with an initial low tumor burden might benefit from a treatment with T-VEC as an alternative treatment option to checkpoint inhibitors and targeted therapies, which in case of progression would still be available. 11 This subgroup was analyzed retrospectively with limited conclusions due to the small number of patients. 13 However, large multicenter studies of checkpoint inhibitors and BRAF and MEK inhibitors did not pre-specify the subgroup of stage IIIB–IVM1a melanoma patients during recruitment. Well-implemented systemic therapies, like checkpoint inhibitors (CTLA-4, PD-1 Inhibitors) 10–12 and targeted therapies (BRAF and MEK inhibitors) dramatically improved survival of patients with metastatic melanoma. While the impact of T-VEC on overall survival (OS) did not show significance in the intention to treat population it did significantly improve OS in patients with stage IIIB, IIIC and IVM1a in a descriptive post hoc analysis. 1 7 Intralesional treatment with T-VEC, which was compared with subcutaneous application of human GM-CSF led to durable responses over at least 6 months, the primary endpoint of the OPTIM trial, in 25,2% of patients over only 1.2% in the GM-CSF arm.

#Rea study center trial#

Approval, in 2015, was based on the results of the phase III study Oncovex Pivotal Trial in Melanoma (OPTiM). 5 6 These modifications enhance tumor-selective replication, reduce virally mediated suppression of antigen presentation, and induce tumor-specific T-cell responses. 4 HSV-1 is modified through (1) the deletion of a neurovirulence gene (ICP34.5) and a immunogenicity gene (ICP47) and (2) the insertion of two gene copies encoded for human granulocyte macrophage colony-stimulating factor (GM-CSF). 3 T-VEC is a genetically modified oncolytic herpes simplex virus type 1 (HSV-1).

1 2 It is injected directly into metastatic lesions. Talimogene laherparepvec (T-VEC) is the first approved intralesional oncolytic therapy in the European Union, the USA and Australia for the treatment of unresectable stage IIIB, IIIC or IVM1a melanoma in Europe and up to IVM1c melanoma in the USA. Correspondence to Dr Julia Maria Ressler .at.10 Department of Dermatology, Landeskrankenhaus Klagenfurt, Klagenfurt, Austria.9 Department of Dermatology, Technische Universität München Fakultät für Medizin, Muenchen, Germany.

8 Department of Dermatology, Paracelsus Medical University Salzburg, Salzburg, Austria.7 Department of Dermatology, Krankenanstalt Rudolfstiftung, Vienna, Austria.6 Department of Dermatology, Krankenhaus der Elisabethinen, Linz, Linz, Austria.5 Department of Onocology, Centre Hospitalier Universitaire Vaudois, Lausanne, VD, Switzerland.4 Department of Dermatology, University Hospital of Zurich, Zuerich, ZH, Switzerland.3 Department of Dermatology, Medical University of Graz, Graz, Austria.Poelten, Karl Landsteiner University of Health Sciences, St Poelten, Austria 2 Department of Dermatology, University Hospital St.1 Department of Dermatology, Medical University of Vienna, Vienna, Austria.