Amgen announced top-line results from the Phase 3 trial of talimogene laherparepvec for the treatment of unresected stage IIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to cause local lytic destruction of tumors while also stimulating a systemic anti-tumor immune response.
This global, randomized, open-label, Phase 3 trial evaluated the safety and efficacy of talimogene laherparepvec in over 400 patients with unresected stage IIB, IIIC or IV melanoma. Patients were randomized 2:1 to receive either talimogene laherparepvec intralesionally every two weeks or GM-CSF subcutaneously for the first 14 days of each 28-day cycle.
The study met its primary endpoint of durable rate response (DRR), defined as the rate of complete or partial response lasting continuously for >6 months. There was a statistically significant difference observed in DRR (16% in the Talimogene laherparepvec arm vs. 2% in the GM-CSF arm).
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