T-VEC was compared with GM-CSF in patients with unresected stage IIIB to IV melanoma in a randomized open-label phase III trial.
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From Ascopubs
Talimogene laherparepvec (T-VEC) is the first oncolytic immunotherapy to demonstrate therapeutic benefit against melanoma in a phase III clinical trial, a new study published online early in the Journal of Clinical Oncology has shown.
For the study, researchers enrolled 436 patients with injectable melanoma that was not surgically resectable and randomly assigned them 2:1 to intralesional T-VEC or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF).
Results showed that the durable response rate was 16.3% (95% CI: 12.1-20.5) and 2.1% (95% CI: 0-4.5) in the T-VEC and GM-CSF groups, respectively (OR = 8.9; P < 0.001). In addition, median overall survival was 23.3 months (95% CI: 19.5-29.6) with T-VEC and 18.9 months (95% CI: 16.0-23.7) with GM-CSF (HR = 0.79; 95% CI: 0.62-1.00; P = 0.051).
Researchers found that T-VEC was particularly effective in patients with treatment-naive disease and in patients with stage IIIB, IIIC, or IVM1a melanoma.
In regard to safety, the most common adverse events associated with T-VEC treatment were fatigue, chills, and pyrexia.
T-VEC is a herpes simplex virus type 1-derived oncolytic immunotherapy ultimately designed to enhance systemic antitumor immune response.
T-VEC was compared with GM-CSF in patients with unresected stage IIIB to IV melanoma in a randomized open-label phase III trial.
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From Ascopubs
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