Amgen presents phase 3 melanoma results

Hannah Blake

pharmaphorum

Amgen has announced top-line results of its phase 3 clinical trials that were evaluating the efficacy and safety of talimogene laherparapvec in for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).

The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months. A statistically significant difference was observed in DRR: 16% in the talimogene laherparepvec arm versus two% in the GM-CSF arm.

The analysis of overall survival (OS), a key secondary endpoint of the study, is event driven, according to Amgen. A pre-planned interim analysis conducted with the analysis of DRR has shown an OS trend in favor of talimogene laherparepvec as compared to GM-CSF. The OS data is expected to mature in late 2013 in line with previous guidance.

"These are the first Phase 3 results of this novel approach to cancer therapy. A high unmet need exists in melanoma and we believe the innovative mechanism of action of talimogene laherparepvec may offer a promising approach for these patients."

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

Among the various types of skin cancer, melanoma is the most aggressive and also the most serious. Although melanoma accounts for less than five% of skin cancer cases, or 132,000 cases globally each year, melanoma accounts for 75% of all skin cancer deaths.

Additional safety and efficacy data will be submitted to the American Society of Clinical Oncology (ASCO) for the 2013 Annual Meeting.