Amgen: Talimogene Laherparepvec Reduced Size Of Melanoma Tumors In New Study

(RTTNews) - Biotechnology giant Amgen Inc (AMGN) Friday said findings from a pre-specified retrospective analysis of patients with metastatic melanoma showed that its investigational drug talimogene laherparepvec reduced the size of injected tumors and non-injected tumors that metastasized to other parts of the body.

The analysis recorded tumor-level responses from a pivotal Phase 3 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 67th Annual Cancer Symposium in Phoenix.

Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumor tissue and to initiate a systemic anti-tumor immune response.

Of the 295 patients treated with talimogene laherparepvec, about 4,000 tumor lesions were tracked for this analysis. Half of these lesions were injected with talimogene laherparepvec at least once. The results showed a 50 percent or greater reduction in tumor size in 64 percent of injected tumors.

In addition, one-third of uninjected non-visceral tumors, and 15 percent of visceral tumors were 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 observed adverse events in the study were fatigue, chills and pyrexia. The most common serious adverse events include disease progression in both groups, and cellulitis and pyrexia in the talimogene laherparepvec group. Serious adverse events occurred in 26 percent of talimogene laherparepvec patients and 13 percent of GM-CSF patients.

Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing the pigment to skin. Melanoma is the most aggressive and serious form of skin cancer.

Currently, 132,000 melanoma cases occur globally each year. In the U.S., while melanoma accounts for less than 5 percent of skin cancer cases, it causes the most skin cancer deaths.