Novartis has announced topline results from the global Phase III CANTOS study investigating the efficacy, safety and tolerability of canakinumab (ACZ885) in combination with standard of care in people with a prior heart attack and inflammatory atherosclerosis. With more than 10,000 patients enrolled in the study over the last six years, CANTOS is one of the largest and longest-running clinical trials in the company’s history.
The CANTOS study met the primary endpoint, demonstrating that when used in combination with standard of care canakinumab reduces the risk of major adverse cardiovascular events (MACE), a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, in patients with a prior heart attack and inflammatory atherosclerosis. The full data from the study will be submitted for presentation at a medical congress and for peer reviewed publication later this year.
“Despite current treatment, about 25% of heart attack survivors will have another cardiovascular event within five years, making the outcome of the CANTOS study a promising new development for patients,” says Vas Narasimhan, global head, Drug Development and chief medical officer, Novartis. “Canakinumab is the first and only investigational agent which has shown that selectively targeting inflammation reduces cardiovascular risk. Our priority now is to thoroughly analyse these important data and discuss them with regulatory agencies.”