Favorable OS Ph III results with Amgen’s talimogene laherparepvec in melanoma patients

USA-based Amgen (Nasdaq: AMGN), the world’s largest independent biotech firm, has presented positive 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 were presented 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 was 23.3 months in the talimogene laherparepvec arm over 19.0 months in the GM-CSF arm (HR = 0.79, 95% 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% CI, 0.38-0.81) or who received talimogene laherparepvec as first-line treatment (HR = 0.49, 95% CI, 0.33-0.74), each comprising around 50% of the study population.

Data complement durable response previously reported