Amgen 2013 Annual Report Download - page 8
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Ivabradine
•In August 2013, we obtained the commercial rights in the United States to Servier's novel oral drug ivabradine, a small molecule inhibitor of the
cardiac f-current (If). Ivabradine is approved in the EU and many other jurisdictions outside of the United States as Procoralan ® for chronic heart
failure and stable angina in patients with elevated heart rates.
Talimogene Laherparepvec
•In March 2013, we announced results from the phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for
the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating
factor (GM-CSF).
The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at
least six months. A statistically significant difference was observed in DRR: 16 percent in the talimogene laherparepvec arm versus two percent in the
GM-CSF arm. A pre-planned interim analysis conducted with the analysis of DRR has shown an overall survival (OS) trend in favor of talimogene
laherparepvec as compared to GM-CSF. The analysis of OS, a key secondary endpoint of the study, is event driven.
Trebananib
•In June 2013, we announced that the phase 3 TRINOVA-1 trial evaluating trebananib plus paclitaxel versus placebo plus paclitaxel in recurrent
ovarian cancer met its primary endpoint of progression-free survival (PFS). A statistically significant difference was observed in PFS with a 34
percent reduction in the risk of disease progression or death. The median PFS was 7.2 months in the trebananib arm versus 5.4 months in the
control arm. The primary analysis of the OS secondary endpoint is event driven.
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