Novartis Announces Positive Phase III V-MONO Trial Results for Leqvio in Low-to-Moderate Risk ASCVD Patients

Aug 29, 2024 09:32 CST Updated 09:32

Novartis

Drug Development and Manufacturing

｜Edited by the Content Team of Zhong Peptide Biochemical

August 28, 2024DayNovartis announced positive results from the Phase III V-MONO study. The study aimed to evaluate the efficacy and safety of Leqvio (inclisiran) administered twice yearly compared to placebo and ezetimibe in low- to medium-risk patients with atherosclerotic cardiovascular disease (ASCVD) who had not received lipid-lowering therapy. The results showed that the study met its primary endpoint, with Leqvio reducing patients' low-density lipoprotein cholesterol (LDL-C) levels.

V-MONO is a 6-month randomized, double-blind, placebo-controlled and active-controlled Phase III clinical study (n=350), divided into a Leqvio monotherapy group (n=174), an ezetimibe monotherapy group (n=89), and a placebo group (n=87). The primary endpoint of the study is the percentage change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to Day 150 in patients receiving Leqvio compared with those in the placebo and ezetimibe groups.

The results showed that, compared with the placebo group and the ezetimibe group, the LDL-C levels of patients in the Leqvio group achieved a clinically meaningful and statistically significant reduction.

Novartis plans to present the study data at an upcoming medical conference and intends to submit it to regulatory authorities.

To explore the potential cardiovascular benefits of Leqvio and thereby expand its eligible patient population, Novartis has launched the VictORION series of studies, such as:

VICTORION-1 PREVENT (V1P) Study (n=14000): Evaluation of the efficacy and safety of Leqvio versus placebo in preventing major adverse cardiovascular events in high-risk primary prevention patients;
VICTORION-2 PREVENT (V2P) Study (n=17006): Evaluation of the Efficacy and Safety of Leqvio versus Placebo in Preventing Major Adverse Cardiovascular Events in High-Risk Secondary Prevention Patients;
VICTORION-INCEPTION Study (n=384): Evaluation of the efficacy and safety of Leqvio in combination with usual care versus usual care alone in reducing LDL-C levels in patients with a recent acute coronary syndrome (ACS).
VICTORION-INCLUSION Study (n=1440): Evaluation of the efficacy and safety of Leqvio in combination with standard therapy versus standard therapy alone in reducing LDL-C levels in high-risk or established ASCVD patients.
ORION-4 Study (n=16,124): Evaluation of the efficacy and safety of Leqvio versus placebo in improving clinical outcomes in patients with ASCVD.

Among them, the V1P study is the only research exploring the effects of non-statin lipid-lowering therapies in a high-risk primary prevention population. The results of the ORION-4 and V2P studies are expected to be available in 2026 and 2027, respectively.

Novartis obtained the global rights to Leqvio from Alnylam Pharmaceuticals in 2013. Currently, Leqvio has been approved in nearly 100 countries and regions, including the United States, the European Union, Japan, and China. Leqvio is the first and only siRNA therapy that can reduce LDL-C, administered via subcutaneous injection. After the initial dose, it is injected again after 3 months, followed by once every 6 months.

Cardiovascular disease is a common cause of death.Fortunately, most cardiovascular deaths can be prevented through certain means.ASCVD accounts for 85% of all cardiovascular death events.This disease is caused by the continuous accumulation of LDL-C in the arteries, forming plaques.Therefore, reducing LDL-C levels can lower the risk of cardiovascular events such as heart attacks or strokes.

Novartis Development President and Chief Medical Officer Dr. Shreeram Aradhye stated, "Many patients still struggle to achieve their cholesterol-lowering goals. We are proud to address this challenge with siRNA therapy. The V-MONO study adds to the growing body of evidence supporting Leqvio's efficacy across the full spectrum of ASCVD."

About Novartis

Novartis is committed to reimagining medicine to improve people’s quality of life and extend human lifespan.We deliver high-value medicines that address the greatest disease burdens in society through our technological leadership in R&D and innovative accessibility initiatives.In the process of exploring new drugs, we have been innovating relentlessly, and our R&D investment has always been at the forefront of the global industry.Novartis has approximately 106,000 employees from over 140 countries and regions worldwide, and nearly 800 million patients globally benefit from Novartis products.

Source:

1.Medcube