Amgen’s melanoma drug improved OS in phase three

Amgen's melanoma drug has been found to improve overall survival (OS) in phase three clinical trials.

The drug, talimogene laherparepvec, was being evaluated in over 400 patients with unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). Analysis of the trial showed that the median overall survival was 23.3 months in the talimogene laherparepvec arm over 19.0 months in the GM-CSF arm.

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

"The interim overall survival subset results complement the durable response data we reported earlier this year and these endpoints appear to correlate with each other in terms of where the most benefit is being seen in this trial. We look forward to the mature overall survival data expected in the first half of next year."

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

"A favorable trend in overall survival was observed in patients who received talimogene laherparepvec and the trend was pronounced in patients with stage III and IV M1a disease where an important clinical need exists for patients whose disease has not yet spread to distant organs. I look forward to seeing the final results next year."

Howard Kaufman, M.D., professor and director of the section of surgical oncology in the Department of General Surgery, Rush University Medical Center in Chicago.

Melanoma is the most aggressive and serious form of skin cancer in which the best treatment approach involves early detection. Currently, 132,000 melanoma cases occur globally each year. Metastatic melanoma remains a devastating and difficult-to-treat disease with a high unmet need.