Amgen reports Phase III melanoma data for immunotherapy

Amgen Inc. (NASDAQ:AMGN) reported top-line data late Tuesday showing that talimogene laherparepvec met the primary endpoint of improving durable response rate (DRR) vs. GM-CSF in a Phase III trial to treat melanoma (16% vs. 2%, p-value not disclosed). DRR was defined as the rate of complete or partial response lasting continuously for six months or more. Amgen said data for the secondary endpoint of overall survival (OS) are expected to mature late this year. The company said a pre-planned interim analysis of the OS endpoint showed a trend in favor of talimogene laherparepvec compared to GM-CSF. The open-label, international trial enrolled more than 400 patients with unresectable stage IIIB, IIIC or IV melanoma.

The company said it is too early to discuss regulatory plans for the modified herpes simplex virus type 1 (HSV-1) encoding GM-CSF. Amgen gained the product through its 2011 acquisition of BioVex Inc. for $425 million up front and up to $575 million in milestones (see BioCentury, Jan. 31, 2011). ...