Amgen Inc recently announced that its experimental and novel treatment for advanced melanoma met its primary endpoint of durable response rate (DRR) in a late stage study.
The Phase III trial evaluated the efficacy and safety of talimogene laherparepvec for treatment of unresected stage IIIB, IIIC, or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). Durable response rate was defined as the rate of complete or partial response lasting continuously for at least six months. They found that patients in the talimogene laherparepvec arm’s DRR was 16 percent compared to two percent in the GM-CSF arm. This was considered a statistically significant increase. Overall survival (OS) was a key secondary endpoint of the study. The analysis of OS is event driven. A pre-planned interim analysis conducted analyzing DRR and OS has shown a trend in favor of the experimental treatment. According to the company, OS data is expected to mature in late 2013 in line with previous guidance.
Talimogene laherparepvec is injected directly into the tumor and replicates until the membrane of the cancer cells rupture. It is designed to cause local lytic destruction of tumors while also stimulating a systematic anti-tumor immune response.
“These are the first Phase 3 results of this novel approach to cancer therapy,” Sean E. Harper, MD, Executive Vice President of Research and Development at Amgen stated. “A high unmet needs exists in melanoma and we believe the innovative mechanism of action of talimogene laherparepvec may offer a promising approach for these patients.”
According to the company, the most common adverse events observed in this 400 patient study were fatigue, child, and pyrexia and the most common serious adverse events consisted of disease progression, cellulitis, and pyrexia.
Melanoma is the deadliest of skin cancers. Melanoma accounts for only less than five percent of skin cancer cases, however it accounts for 75 percent of all skin cancer deaths, according to the World Health Organization.
Amgen plans to present additional safety and efficacy data at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting.
Last Updated: 3/20/13; 10:20AM EST