Systemic Benefit of Gm-Csf-Encoding, Oncolytic Herpes Virus (Talimogene Laherparepvec, T-Vec) in Metastatic Melanoma: Phase Ii Assessment
| Autor: | C. Bedell, S. Horvath, Neil Senzer, John Nemunaitis |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Oncology
medicine.medical_specialty business.industry Melanoma Phases of clinical research Hematology medicine.disease Oncolytic herpes virus Oncolytic virus Surgery Clinical research Response Evaluation Criteria in Solid Tumors Internal medicine medicine Adverse effect business Talimogene laherparepvec |
| Zdroj: | Annals of Oncology. 25:iv365 |
| ISSN: | 0923-7534 |
| DOI: | 10.1093/annonc/mdu342.12 |
| Popis: | Aim: We and others previously conducted a multicenter phase II trial to assess the efficacy and safety of T-VEC, an oncolytic immunotherapy derived from herpes simplex virus type-1, in advanced stage IIIC and IV melanoma patients (Senzer, Nemunaitis et al JCO 2009). Methods: Treatment involved intralesional (IL) injection of up to 4 mL of 106 PFU/mL of T-VEC followed 3 weeks later by up to 4 mL of 108 PFU/mL every 2 weeks for up to 24 treatments. Clinical activity assessed by modified WHO criteria, survival and safety were monitored. Results: Fifty patients (stages IIIC, n = 10; IVM1a, n = 16; IVM1b, n = 4; IVM1c, n = 20) entered trial. The overall response rate by RECIST was 26% (complete response [CR], n = 8; partial response [PR], n = 5) involving both local injected disease sites and systemic (other organ) disease sites. Overall survival was previously reported as 58% at 1 year. Further follow up in the 15 patients treated at MCCRC revealed 33% 2-year survival and 20% 5-year survival. We now report ≥ 5-year follow up of a subset of all 15 patients managed at MCCRC. Four of these patients were previously identified as having achieved complete response involving both local regional and metastatic disease sites including lung and liver. Two of these patients remain alive > 5 years at 2878 and 2184 days after treatment and two survived 1943 and 868 days before disease related mortality. No long-term adverse events were identified in any of the 15 patients including the 3 surviving ≥ 5 years. Conclusions: These results from a single clinical research center demonstrate systemic effect, long term durability of response and no evidence of adverse toxicity to T-VEC. Further long-term analysis is underway to similarly assess all 50 Phase II patients. Disclosure: All authors have declared no conflicts of interest. |
| Databáze: | OpenAIRE |
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