In a nutshell
The authors evaluated the effectiveness of talimogene laherparepvec (T-VEC), a virus therapy, for the treatment of advanced melanoma.
Some background
In advanced melanoma (stage 3/4), cancer spreads from the skin to other parts of the body. Immunotherapy (uses body’s own immune system to fight cancer) and targeted therapy are promising treatment options for this disease. These therapies have shown improvement in overall survival (those who are still alive after the treatment) of patients. Oncolytic viruses are novel immunotherapies for cancer. These include administering live viruses directly into tumors. The viruses grow within the tumors, killing the tumor cells and helping to grow a protein that makes the immune system stronger. This protein is called granulocyte macrophage colony-stimulating factor (GM-CSF).
T-VEC is one such virus immunotherapy targeted to kill melanoma cells. The effect of this immunotherapy in improving durable response rate (DRR) in advanced melanoma needs to be evaluated. DRR is the number of patients who saw a partial or complete response (partial or complete loss of tumors) for 6 months or more.
Methods & findings
The authors aimed to evaluate the DRR of T-VEC in stage 3/4 melanoma that could not be surgically removed.
436 patients were included in this phase III study. 295 patients were randomly assigned to receive T-VEC (group 1) injection directly into the tumor. 141 patients were randomly assigned to receive GM-CSF (group 2) injection in the skin.
In group 1, a DRR was seen in an average of 16.3% of patients. In comparison, a DRR was seen in an average of 2.1% of patients in group 2. The overall response rate (patients who saw a partial plus complete response) was 26.4% in group 1. This was compared to 5.7% in group 2. The overall survival in group 1 patients was 23.3 months. This was compared to 18.9 months in group 2.
The most common side effects in group 1 patients were tiredness, chills and fever.
The bottom line
The authors concluded that T-VEC was a safe and effective virus therapy in advanced melanoma.
Published By :
Journal of clinical oncology
Date :
May 26, 2015
