Novartis Announces New Long-Term Data Showing Leqvio’s Efficacy and Safety Sustained Beyond Six Years
Novartis
Drug Development and Manufacturing
On August 28 US time, Novartis announced the latest long-term research data from the ORION-8 trial, a Phase III open-label extension of the ORION-9, ORION-10, and ORION-11 trials. The study data showed that Leqvio (Inclisiran) administered twice yearly in combination with statins.Efficacy of LDL-C Reduction in ASCVD Patients Can Be Sustained for Over Six Years.
Image Source: Novartis Official Website
ORION-8 is the largest clinical trial completed by Leqvio to date, serving as a supportive study for the consistency, long-term efficacy, safety, and tolerability of Leqvio. The trial has a follow-up period of three years, with a total exposure exceeding 8,500 patient-years.
Novartis has previously completed four related trials (ORION-9, ORION-10, ORION-11, and ORION-3), in which patients received Leqvio dosing every six months for a maximum treatment duration of three years. Nearly 80% (78.4% (95% CI: 76.8, 80.0)) of patients reached the pre-specified LDL-C threshold, with an average reduction in LDL-C levels of approximately 50% (49.4% (95% CI: 48.3, 50.4)).
These results consistently demonstrated efficacy comparable to the LDL-C reduction observed at the end of the initial trial. Furthermore, the long-term safety data align with previous study findings, confirming Leqvio's favorable and superior safety profile.
These long-term study results indicate that when used in conjunction with statins, Leqvio, administered twice a year, demonstrates consistent LDL-C lowering efficacy in ASCVD patients and those at increased risk of cardiovascular disease. Dr. Norman Lepor, a cardiologist from Los Angeles and head of the National Heart Institute, stated that LDL-C is one of the most modifiable risk factors for heart disease, but most patients treated with statins alone fail to reach the recommended LDL-C threshold.
Cumulative exposure to LDL-C leads to arterial plaque growth and increased risk of cardiovascular events. The results of the ORION-8 study confirmed that Leqvio has a sustained efficacy in reducing LDL-C levels in patients.
David Soergel, MD, Global Head of Cardiovascular, Renal and Metabolic Drug Development at Novartis, said that the ORION-8 trial is part of the ongoing VictORION program, which is conducting trials with Leqvio in a large and diverse patient population affected by ASCVD.
VictORION is a large-scale, dynamic clinical trial program co-created with global healthcare partners, aimed at providing confirmatory data on the cholesterol-lowering effects of Leqvio. The program is recruiting over 60,000 patients from more than 60 countries and plans to conduct over 30 clinical trials.
Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C, with the potential to avoid challenges related to treatment adherence, a common issue in cholesterol management. Leqvio has been approved for marketing in over 80 countries/regions, including the United States, the European Union, and China. In the U.S., the FDA approved a label update in July 2023, which means that patients with elevated LDL-C levels and an increased risk of heart disease can receive Leqvio treatment earlier as an adjunctive therapy to dietary modifications and statin therapy.
In addition, Novartis has obtained the global rights for the development, manufacturing, and commercialization of Leqvio under a licensing and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.
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Editor: Pea Shooter
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