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Amgen: Talimogene laherparepvec reduced size of melanoma tumors
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Amgen announced retrospective analysis results of a phase 3 study of patients with metastatic melanoma that showed talimogene laherparepvec reduced the size of injected tumors and noninjected tumors that had metastasized.
“These data add to the body of evidence supporting talimogene laherparepvec’s local and distant effect,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a news release. “Melanoma remains a devastating and difficult-to-treat disease and talimogene laherparepvec continues to demonstrate encouraging results in this setting.”
Researchers studied tumor level response in patients with stage IIIB, IIIC or IV melanoma who were treated with talimogene laherparepvec and were compared with patients treated with granulocyte-macrophage colony-stimulating factor (GM-CSF), according to the release.
Talimogene laherparepvec, an investigational oncolytic immunotherapy, selectively replicates in tumor tissue and initiates a systemic anti-tumor immune response, according to Amgen. It is injected directly into tumor tissue to cause lytic cell death and release an array of tumor-derived antigens. It also is intended to express GM-CSF, which can help activate the immune system.
Two hundred ninety-five patients were treated with talimogene laherparepvec. Of almost 4,000 tumors followed, half were injected with talimogene laherparepvec at least once; the remainder were not injected, including visceral tumor lesions.
Sixty-four percent of injected tumors showed a 50% or greater reduction in size, as did 33% of nonvisceral and 15% of visceral tumors.
Adverse events included fatigue, chills and pyrexia. Serious adverse events included disease progression in both groups, with cellulitis and pyrexia reported in the talimogene laherparepvec group. Serious adverse events were reported by 26% of talimogene laherparepvec patients and 13% of GM-CSF patients.
The study results were presented during an oral session at the Society of Surgical Oncology 67th Annual Cancer Symposium in Phoenix.