Pharmaceutical Business review

Amgen reports positive results of Phase III melanoma trial

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 laherparepvecā€™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.