Talimogene laherparepvec (Amgen) successful pivotal trial for Melanoma
Amgen has announced interim overall survival (OS) results from a pivotal Phase III 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 III study, median OS (overall survival) 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.
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