Novartis announced results from two pooled post hoc analyses of Phase III ORION-9, -10 and -11 trials that showed twice-yearly Leqvio (inclisiran) provided effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction in two sub-populations of atherosclerotic cardiovascular disease (ASCVD) – established cerebrovascular disease (CeVD) and polyvascular disease (PVD). Results were presented at the ESC Congress 2021, organized by the European Society of Cardiology (ESC).
In the first analysis, patients with established CeVD treated with Leqvio achieved an average 55.2% reduction in LDL-C from baseline to Day 510 compared with placebo (P<.0001). In the second analysis, patients with PVD treated with Leqvio achieved an average 48.9% reduction in LDL-C from baseline to Day 510 compared with placebo (P<.0001). Results were similar for patients without PVD, with an average 51.5% reduction in LDL-C from baseline to Day 510 for Leqvio compared with placebo (P<.0001).
“We know that long-term exposure to persistently elevated LDL-C increases the risk of ASCVD, which may lead to cardiovascular events such as heart attack or stroke. These analyses show that twice-yearly Leqvio provides similar effective and sustained LDL-C reduction in two smaller ASCVD sub-populations – CeVD and PVD – as in the wider Phase III ORION ASCVD population,” said David Soergel, M.D., Global Head of Cardiovascular, Renal and Metabolic Drug Development, Novartis. “As the first and only small interfering RNA to provide effective and sustained LDL-C reduction, Leqvio helps manage a critical cardiovascular risk factor for ASCVD. It is a key component of our ambition to bend the curve of life by reducing and stopping premature death from cardiovascular disease.”
Leqvio was well-tolerated in both analyses, with a modest excess of mainly mild treatment-emergent adverse events (TEAEs) at the injection site that were transient in nature, which is consistent with the results from the overall pooled population from the combined trials. Treatment-emergent serious adverse events (TESAEs) were reported more frequently in patients with PVD, which was likely due to their more advanced disease.
Leqvio is the first and only approved small interfering RNA (siRNA) LDL-C-lowering treatment in Europe. It is currently under review by the U.S. Food and Drug Administration (FDA) and other health authorities.