Amgen announced top-line results from the primary overall survival (OS) analysis of their Phase 3 trial on 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).
This global, open-label Phase 3 study evaluated the safety and efficacy of talimogene laherparepvec in patients randomized 2:1 to receive either talimogene laherparepvec every two weeks through direct tumor injection or GM-CSF subcutaneously for the first 14 days of 28-day cycles, for up to 18 months. Though the primary end point of durable response rate was met previously, the secondary endpoint of overall survival was not; however, data strongly trended in favor of talimogene laherparepvec (P=0.051). The estimated OS hazard ratio and improvement in median OS were similar to what was previously reported at the interim OS analysis.
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Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors and to initiate an immune response to target cancer that has metastasized. It replicates within tumor cells, leading to their rupture and release of tumor-derived antigens and GM-CSF, which stimulate the body’s immune response against cancer cells.
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