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news.Amgen has reported positive results from its Phase III trial evaluating talimogene laherparepvec in patients with injectable unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF).
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Findings from a pre-specified retrospective analysis of patients showed that talimogene laherparepvec reduced the size of injected tumors and also non-injected tumors that had metastasized to other parts of the body.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumor tissue and to begin a systemic anti-tumor immune response.
It is injected directly into tumor tissue and is intended to replicate preferentially in tumor cells causing lytic cell death and releasing an array of tumor-derived antigens
Out of the 295 patients treated with talimogene laherparepvec, about 4,000 tumor lesions were tracked for the analysis.
The results showed a 50% or greater reduction in tumour size in 64% of injected tumours as well as one-third of uninjected non-visceral tumours and 15% of visceral tumours were also reduced by at least 50%.
During the trial, around 35 melanoma-related surgeries were carried out of which 30% successfully removed all residual disease.
Amgen executive vice president of Research and Development Sean Harper said the data adds to the body of evidence supporting talimogene laherparepvec’s local and distant effect, and its potential ability to stimulate a systemic anti-tumour immune response.
"Melanoma remains a devastating and difficult-to-treat disease, and talimogene laherparepvec continues to demonstrate encouraging results in this setting," Harper said.