Amgen’s (AMGN) melanoma treatment, talimogene laherparepvec, showed a four-month longer interim overall survival in a phase 3 trial versus granulocyte-macrophage colony-stimulating factor (GM-CSF).
Amgen (AMGN) on Tuesday 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 GM-CSF. The trial was a global, randomized, open-label, Phase 3 trial to evaluate the safety and efficacy of talimogene laherparepvec in over 400 patients. Results were presented November 18 at the 2013 Society for Melanoma Research (SMR) Congress.
Melanoma is the most aggressive and serious form of skin cancer. It is often not detected until the cancer has spread to other parts of the body. Currently, 132,000 melanoma cases occur globally each year. In the United States, melanoma accounts for less than five percent of skin cancer cases, but it causes the most skin cancer deaths. Moreover, melanoma has a high degree of recurrence.
In the predefined interim analysis, median OS was 23.3 months in the talimogene laherparepvec arm compared with 19.0 months in the GM-CSF arm. The most favorable results so far in the study were 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 Overall survival data for the full study will be presented in the first half of 2014.