THOUSAND OAKS, Calif., Nov. 18, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced interim overall survival (OS) results from a pivotal Phase 3 trial evaluating talimogene laherparepvec in patients with unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). Results will be presented today during an oral session at the 2013 Society for Melanoma Research (SMR) Congress, in Philadelphia.
At a predefined interim analysis of this Phase 3 study, median OS was 23.3 months in the talimogene laherparepvec arm over 19.0 months in the GM-CSF arm (HR = 0.79, 95 percent CI 0.61-1.02; p=0.0746). Differences in survival rates were pronounced in the subset of patients with stage IIIB, IIIC or IV M1a disease (HR = 0.56, 95 percent CI, 0.38-0.81) or who received talimogene laherparepvec as first-line treatment (HR = 0.49, 95 percent CI, 0.33-0.74), each comprising approximately 50 percent of the study population.
"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," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to the mature overall survival data expected in the first half of next year."
The most frequently observed adverse events were fatigue, chills and pyrexia. The most common serious adverse events include disease progression in both arms, and cellulitis and pyrexia in the talimogene laherparepvec arm. Serious adverse events occurred in 26 percent of talimogene laherparepvec patients and 13 percent of GM-CSF patients. Immune-mediated events were reported infrequently.
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