Amgen Says Study of Combination Treatment for Melanoma Meets Primary Endpoint

Amgen (AMGN) reported late Thursday its Phase 2 study of Imlygic in combination with Yervoy met its primary endpoint of objective response rate (ORR) that doubled compared with Yervoy alone, in patients with unresectable advance melanoma.

The study demonstrated Imlygic in combination with Yervoy more than doubled ORR, defined as the proportion of patients with tumor size reduction, compared to ipilimumab alone in patients with unresectable stage IIIB-IV melanoma (39% versus 18%). Patients in the combination arm also experienced nearly double the complete response rate compared to ipilimumab alone (13% versus 7%).

Imlygic is designed to rupture cancer cells causing the release of tumor-derived antigens, which along with granulocyte-macrophage colony-stimulating factor (GM-CSF), may help to initiate an anti-tumor immune response. However, the exact mechanism of action is unknown. This may be complementary to ipilimumab’s mechanism of action, as the blockade of cytotoxic T-lymphocyte-associated antigen-4 has been shown to augment activation and proliferation of tumor infiltrating T-effector cells.

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