Positive analysis of talimogene laherparepvec for Metastatic Melanoma - Amgen

Amgen announced findings from a pre-specified retrospective analysis of patients with Metastatic Melanoma that showed talimogene laherparepvec reduced the size of injected tumours and also non-injected tumours that had metastasized to other parts of the body. The analysis recorded tumour-level responses from a pivotal Phase III study evaluating talimogene laherparepvec in patients with injectable unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). Full results were presented during an oral session at the Society of Surgical Oncology (SSO) 67th Annual Cancer Symposium in Phoenix .

Of the 295 patients treated with talimogene laherparepvec, almost 4,000 tumour lesions were tracked for this analysis. Half of these lesions were injected with talimogene laherparepvec at least once, while the rest were not injected, including visceral tumour lesions (tumours involving solid organs such as the lungs and liver). The results showed a 50 percent or greater reduction in tumour size in 64 percent of injected tumors. In addition, one-third of uninjected non-visceral tumours, and 15 percent of visceral tumours were also reduced by at least 50 percent. There were 35 melanoma-related surgeries performed during this trial of which 30 percent successfully removed all residual disease. The most frequently observed adverse events in the Phase III study were fatigue, chills and pyrexia.